Dr. Daniel F. Hayes, M.D. - Curriculum Vitae

Daniel F. Hayes, M.D.

Professor, Internal Medicine

University of Michigan Comprehensive Cancer Center

1500 E. Medical Center Drive, #6312 CCC, SPC 5942

Ann Arbor, MI 48109-5942

Tel: 734-615-6725, hayesdf@umich.edu

Curriculum Vitae

Education and Training

May 1974 A.B. Indiana University, Bloomington, Indiana

May 1977 M.S. Indiana University, Bloomington, Indiana

June 1979 M.D. Indiana University School of Medicine, Indianapolis, Indiana

Postdoctoral Training

Internship and Residencies:

July 1979–June 1980 Intern in Medicine, Parkland Memorial Hospital, University of Texas Southwestern Medical School, Dallas, Texas

July 1980–June 1981 Junior Assistant Resident, Parkland Memorial Hospital

July 1981–June 1982 Senior Assistant Resident, Parkland Memorial Hospital

Clinical Fellowships:

July 1982–June 1985 Clinical Fellow in Medicine, Harvard Medical School, Boston

July 1982–June 1985 Fellow in Medical Oncology, Dana-Farber Cancer Institute, Boston

July 1982–June 1985 Clinical Fellow in Medicine, Brigham and Women’s Hospital, Boston

Licensure and Certification

Board Certifications:

September 1982 American Board of Internal Medicine, Certificate No. 88573

November 1985 American Board of Internal Medicine, Medical Oncology, Certificate, No. 88573

State Licenses:

June 1979 Indiana License Registration No. 29468 (inactive)

July 1979 Texas Institutional Permit (inactive)

Nov 1982–Nov 06, 2009 Commonwealth of Massachusetts Board of Registration in Medicine, License No. 49272 (inactive)

February 1996 District of Columbia Registration No. 22014 (inactive)

June 2001–Jan 31, 2014 State of Michigan, Physician License ID No. 4301078842

Aug 31, 2011–Aug 30, 2013 VA Ann Arbor Healthcare System, Without Compensation Consultant, Hematology/Oncology

Academic, Administrative, and Clinical Appointments

Academic Appointments:

July 1985–June 1988 Instructor in Medicine, Harvard Medical School

July 1988–June 1996 Assistant Professor of Medicine, Harvard Medical School

July 1996–June 2001 Associate Professor in Medicine, Georgetown University Medical Center

July 2001–Present Professor of Internal Medicine, University of Michigan Health System

December 2008–Present Stuart B. Padnos Professorship in Breast Cancer, University of Michigan Comprehensive Cancer Center

Administrative Appointments:

2001–2004, University of Michigan Comprehensive Cancer Center Protocol Review 2009– Committee

2001– University of Michigan Comprehensive Cancer Center Breast Oncology Program: Clinical Director

2001– University of Michigan Comprehensive Cancer Center Breast Care Task Force Committee: Member

2002–2003 University of Michigan Comprehensive Cancer Center Pharmacy Committee: Chairperson

2002–2003 University of Michigan Comprehensive Cancer Center Operations Committee: Interim Medical Director

2002 University of Michigan Comprehensive Cancer Center Clinical Executive Committee: Chairperson

2002–2009 University of Michigan Comprehensive Cancer Center Protocol Data Safety Monitoring Board

2006– University of Michigan Comprehensive Cancer Center Clinical/Translational Resource Allocation Committee (CTRAC)

2007– University of Michigan, Department of Internal Medicine Advisory Promotion and Tenure Committee

2008– University of Michigan Department of Internal Medicine Research Incentive Program Committee

2009-2010 University of Michigan Medical School, Dean’s Committee for NCRC Biointerfaces Technology Collaborations

1/25/13 – UofM NCRC Biointerfaces Institute Challenge: Detecting Rare Cells and Particles, invited clinician speaker

2011– University of Michigan Comprehensive Cancer Center

Head & Neck SPORE Scientific Advisory Board

2011– University of Michigan Comprehensive Cancer Center

GI SPORE Scientific Advisory Board

2012– University of Michigan Medical School Office of Research Inaugural Central Biorepository (CBR) Oversight and Governance Committee

2014–2015 CBR Regulatory and Compliance Working Group Charter Committee

2013– University of Michigan Medical School Office of Research Biorepository Pilots Implementation Committee

2013–2014 University of Michigan Comprehensive Cancer Center Director Search Committee.

Clinical Appointments:

1985–1988 Clinical Associate in Medicine, Dana-Farber Cancer Institute

1985–1996 Associate Physician, Brigham and Women’s Hospital

1988–1992 Assistant Physician, Dana Farber Cancer Institute

1992–1996 Medical Director, Breast Evaluation Center, Dana-Farber Cancer Institute

1992–1996 Assistant Professor of Medicine, Dana-Farber Cancer Institute

1996–2001 Clinical Director, Breast Cancer Program, Lombardi Cancer Center, Georgetown University Medical Center

2001– Clinical Director, Breast Oncology Program, University of Michigan Comprehensive Cancer Center

2001– Attending Physician, Medical Oncology Service, University Hospital, University of Michigan Health System

Past Administrative/Clinical Appointments:

Dana-Farber Cancer Institute:

1984–1991 Chief Physician, Staff Health Department

1985–1996 Attending Physician, Medical Oncology Service

1986–1996 Staff Physician, Breast Evaluation Center

1991–1996 Medical Director, Breast Evaluation Center Brigham and Women’s Hospital

1984–1994 Chairperson, Journal Club/Cancer Biology Seminars

1985–1992 HIV Research Safety Committee

1985–1996 Fellowship Selection Committee

1987–1996 Ambulatory Services Committee

1988–1996 Evaluation Committee for the American Board of Internal Medicine Medical Oncology Subspecialty Examination

1991, 1993 Planning Committee, Department of Medicine Retreat

1993–1996 Scientific Review Committee

1993–1996 Strategic Planning Committee, Women’s Cancers Program

1993–1996 Clinical Research Working Group Long Range Information Services Planning Committee

1994 Clinical Re-engineering Committee

1994–1995 Clinical Executive Committee

Georgetown University Medical Center:

1996–2001 Clinical Director, Breast Cancer Program

1996–2001 Attending Physician, Medical Oncology Service

1998–2001 Teaching Attending Physician, General Medical Service

1996–2001 Clinical Research Committee

1996–2001 Program Leader, Clinical Breast Cancer

1996–2001 Histopathology Shared Resource Committee

1996–2001 Blood and Nipple Aspirate Shared Resource Committee

1997–2001 Institutional Principle Investigator, Cancer and Leukemia Group B

Research Interests

Breast Cancer

• Biomarkers

• Circulating tumor cells

• New drug development

GRANTS

Current Peer-Reviewed Grants and Contracts

*UM Office of Research and Sponsored Projects (ORSP) – formerly called the Division of Research Development and Administration (DRDA)

Sponsor: NIH – National Cancer Institute: P30 CA046592 (Wicha, PI)

Hayes Role: Breast Oncology Program, Co-Director (0.60 CM)

Title: U of M Comprehensive Cancer Center Support Grant

Total Project Period: 06/01/2012 – 05/31/2017

Annual Direct Costs: $18,287,645

UM ORSP* #11-PAF04124

Sponsor: NIH – National Cancer Institute: 2-T32-CA-009357-31-A1(Cooney, PI)

Hayes Role: Co-Investigator (0.36 CM)

Title: Oncology Research Training Grant

Total Project Period: 05/01/2013 – 06/30/2018

Annual Direct Costs: $310,231

UM ORSP* #12-PAF03609

Sponsor: Susan G. Komen Foundation: SAC110015 (Hayes, PI)

Hayes Role: Principal Investigator (2.4 CM)

Title: Biomarker studies for personalized breast cancer care.

Total Project Period: 07/01/2010 – 06/30/2015

Annual Direct Costs: $160,000

UM ORSP* #12-PAF07843

Sponsor: Breast Cancer Research Foundation: No number (Rae, PI)

Hayes Role: Co-Investigator (0.60 CM)

Title: Pharmacogenomic predictors of breast cancer endocrine response

Total Project Period: 10/01/2011 – 09/30/2015

Annual Direct Costs: $208,333

UM ORSP* #14-PAF06690

Sponsor: Breast Cancer Research Foundation: No number (Hayes, PI)

Hayes Role: Principal Investigator (0.36 CM)

Title: Financial support for the Breast Cancer Intergroup Correlative Science Studies

Total Project Period: 10/01/2010 – 09/30/2015

Annual Direct Costs: $333,333

UM ORSP* #14-PAF06693

Sponsor: Lilly Clinical Investigator Award, Damon Runyon Fdn: No number (Henry, PI)

Hayes Role: Co-Mentor (0.60 CM concurrent with research activities)

Title: Pain processing pathway analysis in aromatase inhibitor-associated musculoskeletal syndrome.

Total Project Period: 07/01/2010 – 06/30/2015

Annual Direct Costs: No funds requested for co-mentorship role.

UM ORSP* #10-PAF04476

Sponsor: NIH/NCI: U10 CA032102 (SWOG, Baker, PI)

Hayes Role: Co-Investigator (0.60 CM)

Title: Southwest Oncology Group Treatment Grant

Total Project Period: 03/23/2010 – 12/31/2015

Annual Direct Costs: $50,192,450

UM ORSP* #09-PAF00672

Sponsor: NIH: 1R01CA151701-01A1 (Rae, PI)

Hayes Role: Co-Investigator (0.60 CM)

Title: Genetic predictors of anti-estrogen clinical activity in breast cancer patients.

Total Project Period: 06/15/2011 – 03/31/2016

Annual Direct Costs: $291,991

UM ORSP* #10-PAF07148

Sponsor: Susan G. Komen for the Cure® Career Catalyst Research Award (Yao, PI)

Hayes Role: Mentor (0 CM)

Title: Pharmacoepigenetics of noncoding RNAs in breast cancer chemotherapy.

Total Project Period: 07/01/2012 – 06/30/2015

Annual Direct Costs: No funds requested for co-mentorship role.

Sponsor: NIH: 1R01CA170198 (Luker/Takayama, PIs)

Hayes Role: Co-Investigator (0.60 CM)

Title: Modeling therapy of disseminated cancer cells in bone marrow (PQ 17)

Total Project Period: 09/01/2012 – 06/30/2016

Annual Direct Costs: $219,202

UM ORSP* #12-PAF02397

Sponsor: Southwest Oncology Group-Clinical Trials Initiative, L.L.C.

Hayes Role: PI (0 CM)

Title: SWOGS1222: Performance of circulating tumor cell endocrine therapy index from whole blood specimens collected from patients with estrogen receptor positive metastatic breast cancer who participate in SWOG protocol S1222.

Total Project Period: 05/20/2014 – 03/31/2019

Annual Direct Costs: $2,426,822

UM ORSP* #14-PAF04090

Current Contract with Pharmaceutical/Commercial Interests

Sponsor (Direct ): Astra Zeneca AB

Hayes Role: UM PI (0 CM)

Title: Performance of circulating tumor cell-endocrine therapy index as Central Laboratory for a Phase I trial of an oral selective estrogen receptor downregulator in patients with ER positive metastatic breast cancer.

Total Project Period: 11/01/2014–10/31/2016

Annual Direct Costs: $230,225

UM ORSP* #15-PAF01039

Sponsor (Direct ): Washington University at St. Louis

Sponsor (Prime ): Puma Biotechnology, Inc.

UMCC 2013.055 (Hayes, PI)

Hayes Role: UM PI (0 CM)

Title: Ame#1: A Phase II Study of Neratinib in Metastatic HER2 Non-amplified but HER2 Mutant Breast Cancer.

Total Project Period: 07/19/2013–07/31/2018

Annual Direct Costs: $33,492

UM ORSP* #13-PAF06938 + 14-PAF04306

Sponsor (Direct): Translational Research in Oncology (TRIO)

Sponsor (Prime): Pfizer

Hayes Role: PI

Title: A randomized, multicenter, double-blind phase 3 study of PD-0332991 (oral CDK 4/6 inhibitor) plus letrozole versus placebo plus letrozole for the treatment of postmenopausal women with ER (+), HER2 (-) breast cancer who have not received any prior systematic anti-cancer treatment for advanced disease.

Total Project Period: 07/22/2013–07/14/2018

Annual Direct Costs: $182,911

UM ORSP* #13-PAF05619

Sponsor: University of Alabama/Susan G. Komen for the Cure® Foundation

UAB 1028/TBCRC (Hayes, UM PI)

Hayes Role: UM PI (0 CM)

Title: Correlative to UAB 1028: An open label, randomized, Phase II trial of abraxane with or without tigatuzumab in patients with metastatic, triple negative breast cancer.

Total Project Period: 10/26/2010–09/14/2014

Annual Direct Costs: $78,750

UM ORSP* #11-PAF02872

Sponsor: Janssen Diagnostics, Inc. (Johnson & Johnson subsidiary)

No number (Hayes, PI)

Hayes Role: PI (0 CM)

Title: Investigations into the biology of circulating tumor cells in metastatic breast cancer patients.

Total Project Period: 10/12/2011–12/31/2014

Annual Direct Costs: $43,149

UM ORSP* #11-PAF00981

Sponsor: Janssen Research and Development, LLC (Johnson & Johnson subsidiary)

N014591/UMCC 2011.066 (Hayes, PI)

Hayes Role: PI (0 CM)

Title: Randomized, open-label study of abiraterone acetate (JNJ-212082) plus prednisone with or without exemestane in postmenopausal women with ER+ metastatic breast cancer progressing after letrozole or anastrozole therapy

Total Project Period: 03/01/2012 – 06/23/2014

Annual Direct Costs: $235,483

UM ORSP* #11-PAF06732

Sponsor: Janssen Diagnostics, Inc. (Johnson & Johnson subsidiary)

UMCC 2012.132 (Hayes, PI)

Hayes Role: PI (0 CM)

Title: COMETI P2 Trial: Characterization of Circulating Tumor Cells from Patients with Metastatic Breast Cancer Using the CTC-Endocrine Therapy Index

Total Project Period: 04/10/2013–12/31/2014

Annual Direct Costs: $128,377

UM ORSP* #13-PAF00525

Sponsor: Janssen Diagnostics, Inc. (Johnson & Johnson subsidiary)

Hayes Role: PI (0 CM)

Title: Research funding agreement: Support for Hayes’ laboratory regarding CellSearch™ discovery studies

Total Project Period: 04/29/2013–02/28/2015

Annual Direct Costs: $96,464

UM ORSP* #13-PAF04095

Past Pharmaceutical Contracts

1990–91 Centocor, Inc. PI

“Clinical Investigations of the CA15-3 Antigen”

1991–92 Amgen, Inc. PI

“A Phase I Trial of Recombinant Methionyl Human Stem Cell Factor in Patients with Advanced Breast Cancer”

1988–96 Adria Laboratories/Pharmacia/Orion Corporation PI

“A Phase III Clinical Trial Comparing Toremifene to Tamoxifen in Postmenopausal Patients with Metastatic Breast Cancer”

1993–96 Centocor, Inc. PI

“Monitoring with the CA15-3 Radioimmunoassay to Detect Rapid Progression in Patients Receiving Chemotherapy for Metastatic Breast Cancer”

1993–96 Genentech, Inc. PI

“Intravenous Recombinant Humanized Anti-p185 HER-2 Monoclonal Antibody Plus Cisplatin in Patients with Metastatic Breast Cancer”

1995–96 Burroughs Wellcome Co. PI

“A Phase I Trial of Navelbine Given By Three Consecutive Day Dosing with Filgrastim Support in Metastatic Breast Cancer Refractory to Prior Chemotherapy”

1995–96 Amgen, Inc. PI

“A Phase I Trial of Navelbine Given By Three Consecutive Day Dosing with Filgrastim Support in Metastatic Breast Cancer Refractory to Prior Chemotherapy”

2004–07 UMCC #2004.031 Wyeth-Ayerst.Pharmeceuticals, Inc. PI

“A Phase III Randomized, Placebo Controlled, Double-Blind, Study of Oral CCI-779 Administered in Combination with Letrozole vs. Letrozole Alone as First Line Hormonal Therapy in Postmenopausal Women with Locally Advanced or Metastatic Breast Cancer”

2003–09 UMCC #2-19 Wyeth-Ayerst Pharmaceuticals, Inc. PI

“A Phase II Randomized Open-Label Study of Letrozole in Combination with Two Dose Levels and Schedules of Oral CCI-779, or Letrozole Alone, in Postpartum Women with Locally Advanced or Metastic Breast Cancer”

2006–09 UMCC# 2005.115 GlaxoSmithKline PI

“A Phase II Study of Lapatinib for Brain Metastases in Subjects with ErbB2-Positive Breast Cancer Following Trastuzumab-based Systemic Therapy and Cranial Radiotherapy”

2005–09 UMCC #2005.074 Pfizer PI

"A Multi-Center Randomized Clinical Trial Correlating the Effects of 24 Months of Exemestane or Letrozole on Surrogate Markers of Response with Aromatase Polymorphism"

Note: Part of a NIH/NIGMS grant (5U01GM061373); PI effort is supported by the original grant.

2005–10 Pfizer (sub-study)

"Characterization of Rheumatic Symptoms Associated with AIs"

Note: Part of a NIH/NIGMS grant (5U01GM061373); PI effort is supported by the original grant.

2005–11 Novartis (sub-study) PI

Note: Part of a NIH/NIGMS grant (5U01GM061373); PI effort is supported by the original grant.

2010-12 Janssen Diagnostics, Inc. (Johnson & Johnson subsidiary) PI

“A pilot single institutional study to determine the feasibility of quantifying ER, HER2, Ki-67, and Bcl-2 expression in circulating tumor cells (CTC) in a single blood draw from women undergoing a new treatment for metastatic breast cancer.”

Past Peer Reviewed Grants and Contracts

1985 American Cancer Society Physician’s Research Training Fellowship PI

1985–88 National Cancer Institute Clinical Investigator Award (K08) PI

“Immunodiagnostic Approaches to Breast Cancer”

1991–93 National Cancer Institute (R03) PI

“Circulating c-neu Protein in Breast Cancer Patients”

1992 CALGB Chairman’s Development Award PI

1992–95 National Institutes of Health P20 SPORE Grant Investigator

(Donald W. Kufe, M.D., PI)

Project 5: “DF3 Expression in Human Breast Cancer” Investigator

(Donald W. Kufe, M.D., PI)

Project B “Tissue Bank Core” Investigator

(Frederick P. Li, M.D., PI)

1994–95 National Institutes of Health: Small Business Innovation Research Program (SBIR)

“A Videotape for Recruitment to Oncology Clinical Trials” Investigator

(Nancy Avis, Ph.D., PI)

1992–96 National Surgical Adjuvant Breast and Bowel Project PI

“Studies of Adjuvant Therapy for Breast Cancer”

1994–99 National Institutes of Health U01 (CA64057) PI

“Correlative Studies of Angiogenesis in Breast Cancer”

1994–99 Department of Defense, U.S. Army Medical Research Admin Investigator

“Linkage of Molecular and Epidemiological Breast Cancer Investigation with Treatment Data: A Specialized Registry” (O. Ross McIntyre, M.D., PI)

1996–2001 SPORE in Breast Cancer, Lombardi Cancer Center Investigator; (Marc E. Lippman, PI) Director, Core

1996–2001 Department of Defense Breast Cancer Center Support Group Investigator;

(Marc E. Lippman, PI) Director, Project

1998–2001 Cancer and Leukemia Group B (CALGB) PI

Georgetown Main Member Grant

1998–2001 Cancer and Leukemia Group B, (CALGB), Plasma Bank Investigator

(Subcontract from Central Grant, Richard Schilsky, PI)

1998–2001 Chemoprevention Studies in Breast Cancer PI

(NCI Contracts) NOI-CN-65001; NOI-CN-65003

2000–2002 Surrogate Markers as Endpoints: Novel Clinical Design for Combining Standard and Novel Therapies in Breast Cancer Mentor

(Vered Stearns, PI)

The Cancer Research Fund of the Damon Runyon-Walter Winchell Foundation

2003– 2007 Correlative Studies of erbB-2/HER2 and p53 in CALBG Pro PI

NIH/NCI 5R01 CA092461

2005–2007 Tumor banking for the Southwest Oncology Group (SWOG) Co-PI

NIH/NCI 1 U24 CA114748 (Laurence Baker, PI)

2006–2007 Does Adjuvant Breast Cancer Therapy Change Bone Mineral Co-PI

Density (BMD) in Post Menopausal Women? (Cathy Van Poznak, PI)

POP0402593 Susan G. Komen Breast Cancer Fdn

2003–2008 Michigan Center for Health Communications Research Co-PI, Project 3: A Tamoxifen Prophylaxis Decision Aid

(Victor Strecher, PI)

2004–2009 Outcomes of triaged family care in advanced cancer (L. Northouse, PI) Co-Invest.

1R01 CA107383 NIH/NCI

2005–2009 Clinical project involving evaluation of therapy of patients with a variety of malignant tumors. Southwest Oncology Group (SWOG) (Baker, PI) Co-Investigator

2 U10 CA032102 NIH/NCI

2005–2010 Role of EZH2 in breast cancer progression (Kleer, PI) Co-Investigator

5 RO1 CA107469 NIH/NCI

2005–2010 Pharmacogenomics Research Network and Knowledge Base (Flockhart, PI) Co-I

5 U01 GM061373 NIH/NIGMS (UM ORSP #F016656)

2008–2012 Altered brain function in chemotherapy for breast cancer (Cimprich, PI) Co-I

R01 NR10939 NIH/NINR (UM ORSP #06-3716)

2009–2012 Analysis of glycan structural modifications to identify improved biomarkers for breast cancer detection (Misek, PI) Co-I\

2008 –2013 A search for gene fusions/translocations in breast cancer (Chinnaiyan, PI) Co-I

DOD: W81XWH-08-1-0110 (Chinnaiyan, PI)

2009–2014 Genetic risk for osteonecrosis of the jaw (ONJ) in patients with metastatic breast cancer. (Van Poznak, PI) Mentor

NIH/NIDACR: 1 K23-DE-020197 (Van Poznak, PI)

2009–2014 Predictors of ovarian function in women treated with aromatase inhibitors

(Henry, PI) Mentor

NIH/NCI: 1 K07-CA-134747 (Henry, PI)

Honors and Awards

1974 E.J. Stahr Distinguished Senior Award, Indiana University

1978–1979 Internal Medicine Senior Honors Program, Indiana University School of Medicine

2006– America’s Top Doctors

2007 American Society of Clinical Oncology Gianni Bonadonna Breast Cancer Award (Inaugural Recipient)

2008 Teacher of the Year Award, University of Michigan Health System, Division of Hematology/Oncology

2009– Association of American Physicians (AAP), elected member

2009 Shelbyville High School Hall of Fame, Shelbyville, Indiana

2013– Fellow, American Society of Clinical Oncology (FASCO)

2013– Member, American Clinical and Climatological Association (ACCA)

Memberships, Offices and Committee Assignments in Professional Societies:

1981–Present American College of Physicians (ACP)

1999–2000 Medical Knowledge Self Assessment Program 12 Hematology/Oncology Writing Committee

2001–2002 Medical Knowledge Self Assessment Program 13 Hematology/Oncology Committee

2004–2005 Medical Knowledge Self Assessment Program 14 Hematology/Oncology Committee

1986–Present Massachusetts Medical Society

1986–2001 Cancer and Adult Leukemia Group B (CALGB)

1993–2001 Breast Cancer Core Committee, Cadre Member

1995–1996 Vice-Chairperson

1993–2001 Solid Tumor Correlative Sciences Committee

1993–1995 Vice Chairperson

1996–2001 Chairperson

1997–2001 Board of Directors

1997–2001 Foundation, Board of Trustees

1986–Present American Society of Clinical Oncology (ASCO)

1994 Program Committee, Annual Meeting

1994– Tumor Marker Expert Panel

2004– Co-Chair

1996–2001 Breast Cancer Working Group, Chair

2000 Program Committee, Annual Meeting

Chair, Breast Cancer Sub-Committee

2001, 2006 Program Committee, Annual Meeting

2007 Program Committee, Annual Meeting

Chair, Breast Cancer Sub-Committee

2008–2009 Chair-Elect, Scientific Program Committee, Annual Meeting

2009–2010 Chair, Scientific Program Committee, Annual Meeting

2010–2011 Immediate Past Chair, Scientific Program Committee, Annual Meeting

2011–2014 Member, Board of Directors (BOD)

2013–2014 Member, Executive Committee, BOD

2012– Member, Expert Panel, Guidelines development in the use of tumor biomarkers in early stage breast cancer.

2012– Member, Expert Panel, Guidelines development in the use of tumor biomarkers to guide decisions on systemic therapy for woment with advanced stage or recurrent breast cancer.

2013– BOD Liaison, Audit Committee

2013– BOD Liaison, Cancer Survivorship Committee

2013– Reviewer, Conquer Cancer Foundation of ASCO Long-Term International Fellowship (LIFe) Committee

2015–2016 President-Elect

2016–2017 President

2017–2018 Past President

1988–Present American Association of Cancer Research (AACR)

– Member, Cancer Biomarkers Collaborative

1988–2001 International Society of Biological Markers, Working Group on Tumor Marker Criteria

1989–2001 American Association for the Advancement of Science

1992–Present The Breast Cancer Intergroup of North America, NIH, NCI

2003– Chair, Correlative Sciences Committee

1993–Present American Society of Breast Disease (ASBD)

1998–2001 College of American Pathologists (CAP), Breast Cancer Prognostic Factor Committee

2013–2014 College of American Pathologists (CAP), Cancer Committee, ASCO inbound liaison member

1999, 2010 Institute of Medicine (IOM) Review Committees

1999–2001 - Committee to Review Mammography and Beyond: Developing Technologies for the Early Detection of Breast Cancer(published 2001)

2010–2012 - Committee to Review Omics-based Tests for Predicting Patient Outcomes in Clinical Trials (published 2012)

2000–2001 National Cancer Institute (NCI): Breast Cancer Pathology Committee for Common Data Elements

2000–2010 American Joint Committee on Cancer (AJCC)/TNM Committee

2000– Breast Cancer Subcommittee, Member

2006– Breast Cancer Subcommittee, Chair

2001–Present Southwest Oncology Group (SWOG)

2001– Cadre member, Breast Committee

2002– Chair, Breast Cancer Correlative Sciences (Translational Medicine) Committee

2003–2006 Co-Chair, Correlative Sciences Committee

2002–Present Union Internationale Contra Cancer (UICC) TNM Expert Advisory Panel on Breast Tumours

2002–Present National Academy of Clinical Biochemistry (USA) Tumor Marker Guidelines Committee

2003–Present National Comprehensive Cancer Network Guidelines Breast Cancer Committee

2008–Present Friends of Cancer Research (Bethesda, MD)

– Member, FDA Oncology Program Advisory Working Group

2008–Present Center for Medical Technology Policy (CMTP) (Baltimore, MD)

– Member, Advisory Group

2008–2010 U.S. Department of Health & Human Services, Centers for Medicare & Medicaid Services

– Member, Medicare Evidence Development Coverage Advisory Committee (MedCAC)

2009 Peer Review College of the Danish Council for Strategic Research, Danish Ministry for Science, Technology and Innovation (Copenhagen, Denmark)

2009– Association of American Physicians (AAP)

2010– Susan G. Komen for the Cure™

– Member, Scientific Advisory Council (SAC)

– Peer Review Committee, Komen Promise Grants

2010–2012 Worldwide Innovative Networking in Personalized Medicine (WIN)

– Member, Scientific Advisory Board

2013– American Clinical and Climatological Association (ACCA)

Editorial Boards

92–95; 97–01; 05–08 Journal of Clinical Oncology (Editorial Board)

1994–2004 The Breast Journal (Associate Editor)

1996– The Breast (Editorial Board)

1996– Breast Diseases: A Year Book Quarterly (Contributing Editor)

1997–1999 Cancer Therapeutics (Editorial Board)

1998– Breast Cancer Research and Treatment (Assoc. Editor ’98-‘10)

1999–2007 Clinical Breast Cancer (Editorial Board)

2000– Clinical Cancer Research (Editorial Board)

2000–2007 Breast Cancer Research (Editorial Board)

2001– UpToDate Breast Cancer Section Editor

2007– Breast Cancer: Basic and Clinical Research (Editorial Board)

2008– Current Breast Cancer Reports (Editor-in-Chief)

2008– Translational Oncology

Reviewer (in addition to Editorial Boards above)

2006– Journal of the National Cancer Institute

2006– Lancet

2006– New England Journal of Medicine

2006– Molecular Oncology

2009– Journal of Clinical Oncology

Data Safety Monitoring Boards

1995– International Breast Cancer Study Group (all studies) Chairperson

1995–1999 Droloxifene vs. tamoxifen in advanced breast cancer (Pfizer) Chairperson

2002– HERA: A Randomized study of 1 year vs. 2 years vs. no Herceptin in women with HER-2 positive Breast Cancer Chairperson

2013– NeoPHOEBE (conducted by the Breast International Group)

Chairperson

Teaching Activities

Dana-Farber Cancer Institute:

1984–1994 Chairperson, Journal Club/Cancer Biology Seminars for First-Year Clinical Fellows

1985–1996 Preceptor, Brigham and Women’s Hospital Primary Care Residents’ Rotation in Breast Evaluation Center

1985–1986 Attending Physician, Medical Oncology Service

1988–1996 Lecturer, Introduction to Medical Oncology

1992–1996 Chairperson, Breast Evaluation Center Weekly Clinical Conferences

Brigham and Women’s Hospital:

1991–1996 Attending Physician, Internal Medicine Service

1992–1996 Lecturer, “Breast Cancer”, Department of Medicine/Division of Primary Care Medicine

Harvard Medical School:

1984–1991 Lecturer, “Intensive Review of Internal Medicine” BWH postgraduate course

1987–1999 Preceptor, “Introduction to Clinical Medicine” ad hoc Review Committee, M.D. Honors Thesis

1988 Andrew Tager, candidate

1989–1996 Faculty, “Cancer Medicine” DFCI postgraduate course

1991–1996 Faculty, “Office Practice of Primary Care Medicine” BWH postgraduate course

1992 Miriam Scheizer, candidate

1992–1995 Faculty, “Advances and Controversies in Surgery” BWH postgraduate course

1993 Faculty, “Critical Issues in Breast Cancer Management” JCRT postgraduate course

1993 Lecturer, “Biology of the Cancer Cell,” Harvard Medical School graduate course

1995 Faculty, “Modern Surgical Oncology for the General Surgeon,” NEDH postgraduate course

Georgetown University Medical Center

1996–2001 Faculty, Introductory Lectures to Oncology Fellows, “Adjuvant Therapy of Breast Cancer”

1996–2001 Coordinator, Breast Cancer Tumor Board/Didactic Lectures

1997–2001 Faculty, House staff Luncheon Lectures, “Introduction to Breast Cancer”

1997–2001 Faculty, Medical Students and House staff, “Translational Science in Breast Cancer at Lombardi/GUMC”

1996–2001 Presenter, Surgical Grand Rounds, “Adjuvant Therapy of Breast Cancer”

2001 Presenter, Gynecologic Grand Rounds, “Prevention of Breast Cancer”

University of Michigan Health System:

2001– HemOnc 2nd Year Fellow’s Introduction to Clinical Research (Co-Director)

2001– Ad hoc Internal Medicine Morning Report (Ambulatory, Inpatient)

2001– UMCCC Breast Cancer Translational Medicine didactic lectures (Director)

2014– Cancer Biology 554, Dept Pathology, UM Medical School, Breast Cancer lecture for Dr. Christine Canman’s class.

2015– Cancer Biology 554, Dept Pathology, UM Medical School, Breast Cancer lecture for Dr. Christine Canman’s class.

Graduate Students, Post Doctoral Fellows, Clinical Fellows Mentored

Consulting

Scientific Advisory Boards

1988 Farmos/Schering: Clinical trials of toremifene

1992 Genentech: Clinical trials of monoclonal antibody 4D5

1988 Oncogene Sciences: Correlative studies of her-2/neu oncogene

1996 Cancer Research Network, Inc (PI: Charles L. Vogel, M.D.)

1995 Breast Cancer Program, Roswell Park Cancer Institute (PI: Stephen Edge, M.D.)

2004 Breast Cancer Program, Winship Cancer Institute, Emory University (PI: Ruth O’Regan, M.D.)

2007–2010 New York University Cancer Institute, NY, NY

2009–2010 University Klinische Eppendorf Cancer Center, Hamburg, Germany

2009– Tisch Cancer Institute, Mt. Sinai School of Medicine, NY, NY

2009– Oncimmune LLC, De Soto, KS, USA

2009–2010 Halcyon Diagnostics, Inc., Rowley, MA, USA

2012 Seattle Breast SPORE External Advisor, Fred Hutchinson Cancer Research Center, Seattle, WA

2012– Hold’Em for Life Translating Discoveries into Breast Cancer Cures, Marvelle Koffler Breast Centre, Mount Sinai Hospital, Toronto, ON, Canada

2013 Transformative Pathology Review Panel, Ontario Institute for Cancer Research (OICR), Toronto, ON, Canada

2014– Scientific Advisory Board, Ontario Institute for Cancer Research (OICR), Toronto, ON, Canada

Study Sections

1989 Immunotherapy of Breast Cancer (NIH PO1, RL Ceriani, PI) ad hoc

1992 American Joint Commission on Cancer ad hoc (Chair)

(NIH UO1, D Winchester, PI)

1998 National Cooperative Breast Cancer Tissue Resource NIH ad hoc

1998–2002 Sub-Committee H (NIH Clinical Trials) Sitting member

2003–2007 Cancer Biomarkers (NIH ZRG1CBSS) Sitting member

2008 Komen Promise Grants for Breast Cancer Research

2009–2010 Cancer Prevention and Research Institute of Texas (CPRIT), Translational and Clinical Peer Review Committee-1, Dallas, TX

2010– Susan G. Komen for the Cure™; various study sections (chair) as a member of the Komen Scientific Advisory Council

Extramural Invited Presentations (Last 3 years)

1/25/12 Grand Rounds, Oakwood Hospital, Dearborn, MI

- MRI “Staging” of the affected breast. An oncology/evidence-based perspective.

2/11/12 2012 Mayo Clinic, Jacksonville, FL - 5th Annual Breast Cancer Course Update in Individualized Management of Breast Cancer: A Post San Antonio Meeting Update.

- Biomarkers in Breast Cancer Treatment

3/22-23/12 European Breast Cancer Conference (EBCC) 8, Vienna, Austria

- A clinician’s perspective on breast cancer: Many diseases – we need to understand the biology.

- Genomic profiling in breast cancer.

- Biomarkers in breast cancer treatment

3/28/12 Komen Distinguished Lectureship, University of Maryland School of Nursing

- Determining who gets chemotherapy for breast cancer: Biology vs. anatomy.

3/28/12 University of Maryland Greenebaum Cancer Center

- Circulating tumor cells: Counting, and much more.

3/31-4/3/12 2012 AACR Annual Meeting, Chicago, IL

3/31 - Education Session - Current Challenges in Molecular Marker Research:

Tumor Markers 101

4/2 - Scientific Forum:

Circulating tumor cells: Enumeration and molecular characterization are great, but do they have clinical utility?

4/3 - Science Policy Session (Panel presentation) - Evolutions of Translational Omics– Lessons learned and path forward: A new report from the Institute of Medicine:

Observations on the recommended evaluation process.

04/24/12 Dana-Farber Cancer Institute Clinical Investigator Seminar Series, Boston, MA

- Biomarkers

06/15/12 Nobel Conference on Breast Cancer, Stockholm, Sweden

- Circulating Tumor Cells: Current and Potential Clinical Utility and What They Can Teach Us About the Biology of Metastases.

06/28/12 3rd UK Breast Cancer Forum, Royal College of Physicians, London

- Can biology trump anatomy for adjuvant chemotherapy decisions?

09/27/12 The Robert A. Phillips Lecture, Ontario Institute of Cancer Research, Toronto, Ontario, Canada

- Selection of adjuvant chemotherapy for breast cancer: Can biology trump anatomy?

01/10/13 Defining Clinical Utility of Molecular Diagnostics for Cancer Treatment Workshop, PACCT (The Program for the Assessment of Clinical Cancer Tests), Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Bethesda, MD

- Generation of an OMICs-based Tumor Biomarker Test: the Institute of Medicine Recommendations for a Pathway Forward

01/17/13 13th Cours Francophone Superieur sur le Cancer du Sein, Nice, France

- Who should receive adjuvant chemotherapy in 2013?

02/1/13 15th International Symposium on Anti-Angiogenic Therapy, San Diego, CA

- Promise and pitfalls of anti-angiogenic therapy in the adjuvant setting.

02/13/13 3rd Annual Circulating Tumor Cells: Future of Cancer Management conference, San Francisco, CA

- Circulating Tumor Cells: Current clinical utility and future directions.

03/13/13 13h International St. Gallen Breast Cancer Conference: Primary Therapy of Early Breast Cancer: Evidence, Controversies and Consensus, St. Gallen, Switzerland

- From the genoma to bedside: Are we lost in translation?

4/5/13 BIG-NABCG Annual Meeting, Washington, DC

(Breast International Group and North American Breast Cancer Group)

Session: Shaping the BCRF “Evelyn Lauder Founder’s Fund” International Research Program for Metastatic Breast Cancer

– Proposal to fund collection and analysis of metastatic biopsies of patients going on clinical trials: D. Hayes.

A separate proposal for the adjuvant setting: SAGE challenge to use “omics” to identify patients not suitable for future adjuvant trials in view of their excellent prognosis: D. Hayes and S. Friend.

04/11-12/13 Annual meeting of the Danish Society for Clinical Oncology (DSKO), Nyborg, Denmark, combined with a yearly course for PhD students.

- Clinical testing of biomarkers (Key Note Lecture presented to PhD students)

- Biomarkers in breast cancer (Key Note Lecture presented to DSKO)

05/7/13 Dana-Farber Cancer Institute Clinical Investigator Seminar Series, Boston, MA

- Circulating Tumor Cells

06/20/13 Canadian Breast Cancer Symposia (CBCS), Toronto, Ontario, Canada

- Personalizing the treatment of breast cancer – what lies ahead?

06/26/13 St. Luke’s Hospital, Breast Center, Tokyo, Japan

- Discovery and evaluation of tumor biomarker tests: A bad tumor marker is as bad as a bad drug.

06/27-29/13 21st Annual Meeting Japanese Breast Cancer Society, Hamamatsu, Japan

- Choosing Chemotherapy for Patients with Early Stage Breast Cancer:

- Can Biology Trump Anatomy?

- Adjuvant chemotherapy in breast cancer in view of St. Gallen 2013

- Meet the Professor Session: Use of biomarkers in the clinical setting

10/5-7/13 5th International Symposium Primary Systemic Treatment in the Management of Operable Breast Cancer: Towards the rapid assessment of therapy efficacy, U.O.M. Patologia Mammaria Breast Cancer Center – Azienda Istituti Ospitalieri de Cremona, Italy

- Which benefits from neoadjuvant in clinical routine and research perspective?

11/08/13 Circulating Nucleic Acids in Plasma and Serum (CNAPS VIII), Baltimore, MD

Session 4 – Special Session – Legal, Regulatory and Clinical Considerations of CNAPS

- Vicious Cycle

02/07/14 University of Miami Miller School of Medicine, Sylvester Comprehensive Cancer Center, Miami, FL

- Circulating tumor cells in breast cancer

03/28/14 2014 Lymphangioleiomyomatosis (LAM) Foundation Research Conference, Chicago, IL

- Biomarker Development and Validation in Breast Cancer: the Paradigm of Estrogen Receptor

04/10/14 Clinical Investigator Training Program, Dana-Farber Cancer Institute, Massachusetts General Hospital, Boston, MA

- Breast Cancer 101

04/11/14 Visiting Professor, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University

- Adjuvant chemotherapy for breast cancer: Can biology trump anatomy?

05/07/14 Pre-IMPAKT 2014 Training Course, Brussels, Belgium

- How to report translational research results

05/08/14 IMPAKT 2014, Brussels, Belgium

- Liquid biopsies for genotyping and monitoring breast cancer: Ready for Prime Time?

05/10/14 BIG/NABCG meeting, Brussels, Belgium

- Clinical trials in the Omics era

08/08/14 Grand Rounds presentation, Josephine Ford Cancer Center, Henry Ford Hospital, Detroit, MI

- Neoadjuvant chemotherapy for breast cancer: Facts and fiction.

10/10/14 Visiting Professor, Bromberg Lecture, University of Texas Southwestern, Dallas, TX

- Selection of Patients for Breast Cancer Adjuvant Chemotherapy: Can Biology Trump Anatomy?

11/07/14 Eli Lilly Oncology, Indianapolis, IN

- Incorporating and using tumor biomarkers in translational research and routine clinical care

01/29/15 Yale University, New Haven, CT

- Circulating Tumor Markers. Present Status and Future Directions: Liquid biopsies?

01/30/15 Institute of Medicine (IOM) of the National Academies, Committee on Policy Issues in the Clinical Development and Use of Biomarkers for Molecularly Targeted Therapies

- Study context—Current landscape for biomarkers for molecularly targeted therapies.

03/12/15 MidMichigan Health Symposium, Midland, MI

- Selection of Patients for Breast Cancer Adjuvant Chemotherapy: Can Biology Trump Anatomy?

03/18/15 St. Gallen International Oncology Conference, Vienna, Austria

- Clinical utility of genetic signatures in selecting adjuvant treatment: risk stratification in early versus late recurrences

04/23-25/15 Global Breast Cancer Conference (GBCC 2015) & 4th International Breast Cancer Symposium (4th IBCS), Korean Breast Cancer Society, Jeju Island, Korea

- Plenary Speaker: “TBD”

11/23/15 5th Seattle Symposium in Biostatistics, Seattle, WA

- Topic: Clinical trials for diagnosis, prognosis, and intervention

12/08/15 San Antonio Breast Cancer Symposium (SABCS), San Antonio, TX

- Education Session: “Predictive gene expression profiles in breast cancer, where are we?

Patents

•Title: Method for predicting progression free and overall survival at each follow-up time point during therapy of metastatic breast cancer patients using circulating tumor cells.

Filed 14 Mar 2005 with the European Patent Office, Netherlands.

Application No./Patent No. 05725638.0-1223-US2005008602.

United States Patent Application Publication No. US 2009/0061456 A1

Applicant/Proprietor: Immunicon Corporation. Inventors: William J. Allard, Harleysville, PA (US); Gerald V. Doyle, Radnor, PA (US); Daniel F. Hayes, Ann Arbor, MI (US); Michael Craig Miller, Quakertown, PA (US); Leon W.M.M. Terstappen, Huntington Valley, PA (US).

Correspondence address: Philip S. Johnson, Johnson & Johnson, One Johnson & Johnson Plaza, New Brunswick, NJ 08933-7003 (US).

•Title: Diagnosis and treatment of breast cancer.

Technology title: Monitoring CTC cells in women with EP positive metastatic breast cancer.

Originally filed 07/09/2008; U.S. Provisional Patent Application.

Original Application No. 61/079,642; Pending 7/7/2011 PCT/US2011/043189

Applicant/Proprietor: University of Michigan. Daniel F. Hayes, MD is designated as sole inventor. UM contact: Ms. Robin Rasor, robinlr@umich.edu . (Update 2/01/2012 provided by Laura Charlick, charlick@umich.edu ).

• Title: Circulating Tumor Cell Capturing Techniques and Devices

Originally filed 1/31/12; Original Application No. 61/593,092. PENDING.

Applicant Proprietor: University of Michigan. Daniel F. Hayes, MD is designated as inventor/co-inventor.

Bibliography

Peer-Reviewed Journals and Publications:

1. Rothgeb TM, Jones BN, Hayes DF, and Gurd RS. Methylation of glucagon, characterization of the sulfonium derivative, and regeneration of the native covalent structure. Biochemistry. 1977; 16:5813–5818.

2. Wittebort RJ, Hayes DF, Rothgeb TM, and Gurd RS. The quantitation of carbamino adduct formation of angiotensin II and bradykinin. Biophys J. 1978; 24:765–778.

3. Kufe D, Inghirami G, Abe M, Hayes D, Justi-Wheeler H, and Schlom J. Differential reactivity of a novel monoclonal antibody (DF3) with human malignant versus benign breast tumors. Hybridoma. 1985; 3:223–232.

4. Hayes DF, Sekine H, Ohno T, Abe M, Keefe K, and Kufe DW. Use of a murine monoclonal antibody for detection of circulating plasma DF3 antigen levels in breast cancer patients. J Clin Invest. 1985; 75:1671–1678.

5. Sekine H, Hayes DF, Ohno T, Keefe KA, Schaetzl E, Bast RC, Knapp R, and Kufe DW. Circulating DF3 and CA125 antigen levels in serum from patients with epithelial ovarian carcinoma. J Clin Oncol. 1985; 3:1355–1363.

6. Hayes DF, Lechan RM, Postner MR, Weichselbaum RR, Miller D, and Ervin TJ. The syndrome of inappropriate antidiuretic hormone secretion associated with induction chemotherapy for squamous cell carcinoma of the head and neck. J Surg Oncol. 1986; 32:150–152.

7. Hayes DF, Zalutsky M, Kaplan W, Noska M, Thor A, Colcher D, and Kufe D. Pharmacokinetics of radiolabeled monoclonal antibody B6.2 in patients with metastatic breast cancer. Cancer Res. 1986; 46:3157–3163.

8. Hayes DF, Zurawski Jr VR, and Kufe DW. Comparison of circulating CA15-3 and carcinoembryonic antigen levels in patients with breast cancer. J Clin Oncol. 1986; 4:1542–1550.

9. Friedman EL, Hayes DF, and Kufe DW. Reactivity of monoclonal antibody DF3 with a high molecular weight antigen expressed in human ovarian carcinomas. Cancer Res. 1986; 46:5189–5194.

10. Sheldon T, Hayes DF, Cady B, Parker L, Osteen R, Silver B, Recht A, Come S, Henderson IC, and Harris JR. Primary radiation therapy for locally advanced breast cancer. Cancer. 1987; 60:1219–1225.

11. Hayes DF, Sekine H, Marcus D, Alper CA, and Kufe DW. Genetically determined polymorphism of the circulating human breast cancer-associated DF3 antigen. Blood. 1988; 71:436–440.

12. Hayes DF, Noska M, Kufe DW, and Zalutsky M. Influence of radioiodination method on the binding of monoclonal antibody DF3 to breast carcinoma cells. Nucl Med Biol. 1988; 15:235–241.

13. Siddiqui J, Abe M, Hayes D, Shani E, Yunis E, and Kufe D. Isolation and sequencing of a cDNA coding for the human DF3 breast carcinoma-associated antigen. Proc Natl Acad Sci, U S A. 1988; 85:2320–2323.

14. Tondini C, Hayes DF, Gelman R, Henderson IC, and Kufe DW. Comparison of CA15-3 and carcinoembryonic antigen in monitoring the clinical course of patients with metastatic breast cancer. Cancer Res. 1988; 48:4107–4112.

15. Hull S, Bright A, Carraway K, Abe M, Hayes D and Kufe DW. Oligosaccharide differences in the DF3 sialomucin antigen from normal human milk and the BT-20 human breast carcinoma cell line. Cancer Commun. 1989; 1:261–267.

16. Tondini C, Pap SA, Hayes DF, Elias AD, and Kufe D. Evaluation of monoclonal antibody DF3 conjugated with ricin as a specific immunotoxin for in vitro purging of human bone marrow. Cancer Res. 1990; 50:1170–1175.

17. Hayes DF, Silberstein DS, Rodrique S, and Kufe DW. DF3 antigen, a human epithelial cell mucin, inhibits adhesion of eosinophils to antibody-coated targets. J Immunol. 1990; 145:962–970.

18. Perey L, Hayes D, Tondini C, van Melle G, Bauer J, Lemarchand T, Reymond M, Mach J, and Leyvraz S. Elevated CA125 levels in patients with metastatic breast carcinoma. Br J Cancer. 1990; 62:668–670.

19. Maimonis P, Hayes DF, O’Hara C, and Kufe D. Detection and characterization of a high-molecular weight human lung carcinoma-associated glycoprotein. Cancer Res. 1990; 50:6738–6743.

20. Hayes DF, Mesa-Tejada R, Papsidero L, Croghan G, Korzun A, Norton L, Wood W, Strauchen J, Grimes M, Weiss R, Ree H, Thor A, Koerner F, Rice M, Barcos M, and Kufe DW. Prediction of prognosis in primary breast cancer by detection of a high molecular weight mucin-like antigen using monoclonal antibodies DF3, F36/22, and CU18: A Cancer and Leukemia Group B study. J Clin Oncol. 1991; 9:1113–1123.

21. Maimonis P, Hayes DF, Schaffel S and Kufe DW. Lung cancer associated protein: Development and characterization of a new assay that detects a circulating lung cancer marker. Cancer Res. 1991; 51:3838–3842.

22. Carney W, Hamer P, Petit D, Retos C, Greene R, Zabrecky J, McKenzie S, Hayes DF, Kufe DW, DeLellis R, Naber S, and Wolfe H. Detection and quantitation of the neu oncoprotein. J Tumor Marker Oncol. 1991; 6:53–72.

23. Abner AL, Recht A, Vicini FA, Silver B, Hayes D, Come S, and Harris JR. Cosmetic results after surgery, chemotherapy, and radiation therapy for early breast cancer. Intl J Rad Oncol Biol Physics. 1991; 21:331–338.

24. Perey L, Hayes DF, Maimonis P, Abe M, O’Hara C, and Kufe D. Tumor specific reactivity of a monoclonal antibody prepared against a recombinant peptide derived from the DF3 human breast carcinoma-associated antigen. Cancer Res. 1992; 52:2563–2568.

25. Damstrup L, Anderson J, Kufe DW, Hayes DF, and Poulsen HS. Immunocytochemical determination of the estrogen-regulated proteins Mr 24,000, Mr 52,000 and DF3 breast cancer associated antigen: Clinical value in advanced breast cancer and correlation with estrogen receptor. Ann Oncol. 1992; 3:71–77.

26. Fisken J, Roulston JE, Beattie G, Hayes DF, and Leonard RCF. Investigation of the c-neu proto-oncogene related protein (NRP) in the serum of primary epithelial ovarian cancer patients using a novel immunoassay. Intl J Gynecol Cancer. 1992; 2:134–140.

27. Perey L, Hayes DF, and Kufe D. Effects of differentiating agents on cell surface expression of the breast carcinoma-associated DF3-P epitope. Cancer Res. 1992; 52:6365–6370.

28. Abner A, Recht A, Eberlein T, Come S, Shulman L, Hayes DF, Connolly J, Silver B, and Harris J. Prognosis following salvage mastectomy for recurrence in the breast after conservative surgery and radiation therapy for early stage breast cancer. J Clin Oncol. 1993; 11:44–48.

29. Shapiro CL, Gelman RS, Hayes DF, Osteen R, Obando A, Canellos GP, Frei III E, and Henderson IC. Comparison of adjuvant chemotherapy with methotrexate and fluorouracil with and without cyclophosphamide in breast cancer patients with one to three positive axillary lymph nodes. J Natl Cancer Inst. 1993; 85:812–817.

30. Andrews Jr CW, Jessup JM, Goldman H, Hayes DF, Kufe DW, O’Hara CJ, and Steele Jr GD. Localization of tumor-associated glycoprotein DF3 in normal, inflammatory, and neoplastic lesions of the colon. Cancer. 1993; 72:3185–3190.

31. Nguyen M, Watanabe H, Budson A, Richie JP, Hayes DF, and Folkman J. Elevated levels of an angiogenic peptide, basic fibroblast growth factor, in the urine of patients with a wide spectrum of cancers. J Natl Cancer Inst. 1994; 86:356–361.

32. Janicek MJ, Hayes DF, and Kaplan WD. Healing flare in skeletal metastases from breast cancer. Radiology. 1994; 192:201–204.

33. Nixon AJ, Neuberg D, Hayes DF, Gelman R, Connolly JL, Schnitt S, Abner A, Recht A, Vicini F, and Harris JR. Relationship of patient age to pathologic features of the tumor and prognosis for patients with Stage I or II breast cancer. J Clin Oncol. 1994; 12:888–894.

34. Vogel CL, Schoenfelder J, Shemano I, Hayes DF, and Gams RA. Worsening bone scan in the evaluation of antitumor response during hormonal therapy of breast cancer. J Clin Oncol. 1995; 13:1123–1128.

35. Shapiro CL, Dezube BJ, Tretyakov O, Wright J, Cap B, Henderson IC, and Hayes DF. Dose escalation of thioTEPA combined with pentoxifylline for advanced breast cancer. Clin Cancer Res. 1995; 1:791–796.

36. Hayes DF, Van Zyl JA, Hacking A, Goedhals L, Bezwoda WR, Mailliard JA, Jones SE, Vogel CL, Berris RF, Shemano I, and Schoenfelder J. Randomized comparison of tamoxifen and two separate doses of toremifene in postmenopausal patients with metastatic breast cancer. J Clin Oncol. 1995; 13:2556–2566.

37. Perry JJ, Berry DA, Weiss RB, Hayes DF, Duggan DB, and Henderson IC. High dose toremifene for estrogen and progesterone receptor negative metastatic breast cancer: A phase II trial design of the Cancer and Leukemia Group B (CALGB). Breast Cancer Res Treat. 1995; 36:35–40.

38. Costa JJ, Demetri GD, Harrist TJ, Dvorak AM, Hayes DF, Merica E, Menchaca DM, Gringeri AJ, Schwartz LB, and Galli SJ. Recombinant human stem cell factor (kit ligand) promotes human mast cell and melanocyte hyperplasia and functional activation in vivo. J Exp Med. 1996; 183:2681–2686.

39. Recht A, Come S, Henderson IC, Gelman RS, Silver B, Hayes DF, Shulman L, and Harris J. Five-year results of a randomized trial testing the sequencing of chemotherapy and radiation therapy following conservative surgery for patients with early stage breast cancer. N Engl J Med. 1996; 334:1356–1361.

40. Hayes DF, Bast R, Desch CE, Fritsche H, Kemeny N, Locker G, MacDonald J, Mennel R, Ravdin P, Norton L, Taube S, and Winn R. A Tumor Marker Utility Grading System (TMUGS): A framework to evaluate clinical utility of tumor markers. J Natl Cancer Inst. 1996; 88:1456–1466.

41. Tumor Marker Expert Panel, American Society of Clinical Oncology. Clinical practice guidelines for the use of tumor markers in breast and colorectal cancer. J Clin Oncol. 1996; 14:2843–2877. (Practice Guidelines – Dr. Hayes was a sitting member of the Panel and wrote an entire section.)

42. Gershanovich M, Hayes DF, Ellmen J, and Vuorinen J. High-dose toremifene vs tamoxifen in postmenopausal advanced breast cancer. Oncology (Huntingt). 1997; 11:2936.

43. Shapiro CL, Ayash L, Webb I, Gelman R, Keating J, Williams L, Demetri G, Clark P, Elias A, Duggan D, Hayes DF, Hurd D, and Henderson IC. Repetitive cycles of cyclophosphamide, thiotepa, and carboplatin (CTCb) intensification with peripheral blood progenitor cells (PBPC) and filgrastim (G-CSF) in advanced breast cancer patients. J Clin Oncol. 1997; 15:674–683.

44. Yamauchi H, O’Neill A, Gelman A, Carney W, Hosch S, Kufe DW, and Hayes DF. Elevated circulating HER-2/neu-related protein (NRP) is associated with low response rate to first-line hormone therapy in patients with estrogen and/or progesterone receptor positive (ER, PR Pos) advanced breast cancer. J Clin Oncol. 1997; 15:2518–2525.

45. Roach M, Cirrincione C, Budman D, Hayes DF, Henderson IC, Berry D, Younger J, and Hart R. Race is not an independent prognostic factor for women receiving adjuvant chemotherapy for stage II breast cancer: An analysis based on CALGB 8541. Cancer J Sci Am. 1997; 3:107–112.

46. Pegram M, Lipton A, Hayes DF, Weber B, Baselga J, Tripathy D, Baly D, Baughman S, Twaddell T, Glaspy J, and Slamon D. Phase II study of receptor-enhanced chemosensitivity using recombinant humanized anti-p185HER2/neu monoclonal antibody plus cisplatin in patients with HER2/neu-overexpressing metastatic breast cancer refractory to chemotherapy treatment. J Clin Oncol. 1998; 16:2659–2671.

47. Shapiro CL, Hardenbergh-Harrigan P, Gelman R, Blanks D, Hauptman P, Recht A, Hayes DF, Harris J, and Henderson IC. Cardiac effects of adjuvant doxorubicin and radiation therapy in breast cancer patients. J Clin Oncol. 1998; 16:3493–3501.

48. Jacobs T, Siziopikou K, Prioleau J, Raza S, Baum J, Hayes DF, and Schnitt S. Do prognostic marker studies on core needle biopsy specimens of breast carcinoma accurately reflect the marker status of the tumor? Modern Pathol. 1998; 11:259–264.

49. Watanabe M, Wallace P, Keler T, Deo Y, and Hayes DF. Antibody Dependent Cellular Phagocytosis (ADCP) and Antibody Dependent Cellular Cytotoxicity (ADCC) of Breast Cancer Cells Mediated by Bispecific Antibody, MDX-210. Breast Cancer Res Treat. 1999; 53:199–207.

50. Havlin KA, Ramirez MJ, Legler CM, Harris LN, Matulonis UA, Hohneker JA, Hayes DF, and Winer EP. Inability to escalate vinorelbine dose intensity using a daily x3 schedule with and without filgrastim in patients with metastatic breast cancer. Cancer Chemother Pharmacol. 1999; 43: 68–72.

51. Hardenbergh PH, Recht A, Gollamudi S, Come SE, Hayes DF, Shulman LN, O’Neill A, Gelman RS, Silver B, and Harris JR. Treatment-related toxicity from a randomized trial of the sequencing of doxorubicin and radiation therapy in patients treated for early stage breast cancer. Intl J Rad Oncol Biol Physics. 1999; 45:69–72.

52. Shapiro CL, Ervin T, Welles L, Azarnia N, Keating J, and Hayes DF. Phase II trial of high-dose liposome-encapsulated doxorubicin with granulocyte colony-stimulating factor in metastatic breast cancer. TLC D-99 Study Group. J Clin Oncol. 1999; 17:1435–1441.

53. Shapiro CL, Keating J, Angell JE, Janicek M, Gelman R, Hayes D, and LeBoff MS. Monitoring therapeutic response in skeletal metastases using dual-energy x-ray absorptiometry: A prospective feasibility study in breast cancer patients. Cancer Invest. 1999; 17:566–574.

54. Pyrhonen S, Ellmen J, Vuorinen J, Gershanovich M, Inaga T, Kaufman M, and Hayes DF. Meta-analysis of trials comparing toremifene with tamoxifen and factors predicting outcome of antiestrogen therapy in postmenopausal women with breast cancer. Breast Cancer Res Treat. 1999; 56: 133–143.

55. Stearns V, Isaacs C, Rowland J, Crawford J, Ellis M, Kramer R, Lawrence W, Hanfelt J, and Hayes DF. A pilot trial assessing the efficacy of paroxetine hydrochloride (Paxil â) in controlling hot flashes in breast cancer survivors. Ann Oncol. 2000; 11:17–22.

56. Guidi A, Berry D, Broadwater G, Perloff M, Norton L, Barcos M, and Hayes D. Association of angiogenesis in lymph node metastases and disease outcome in patients with breast cancer. J Natl Cancer Inst. 2000; 92:486–492.

57. Baidas S, Winer EP, Fleming G, Harris L, Pluda J, Crawford J, Yamauchi H, Isaacs C, Hanfelt J, Tifft M, Flockhart D, Johnson M, Hawkans MJ, Lippman ME, and Hayes DF. Phase II evaluation of thalidomide in patients with breast cancer. J Clin Oncol. 2000; 18:2710–2717.

58. Berry DA, Muss HB, Thor AD, Dressler L, Liu ET, Broadwater G, Budman DR, Henderson IC, Barcos M, Hayes DF, and Norton L. HER-2/neu and p53 expression versus tamoxifen resistance in estrogen receptor-positive, node-positive breast cancer. J Clin Oncol. 2000; 18:3471–3479.

59. Yamauchi H, Stearns V, and Hayes DF. 2001. When is a tumor marker ready for prime time? A case study of c-erbB-2 as a predictive factor in breast cancer. J Clin Oncol. 2001; 19:2334.

60. Akewanlop C, Watanabe M, Singh B, Walker M, Kufe DW, and Hayes DF. Phagocytosis of breast cancer cells mediated by anti-MUC-1 monoclonal antibody, DF3, and its bispecific antibody. 2001; Cancer Res. 61:4061.

61. George DJ, Halabi S, Shepard TF, Vogelzang NJ, Hayes DF, Small EJ, and Kantoff PW. Prognostic significance of plasma vascular endothelial growth factor levels in patients with hormone-refractory prostate cancer treated on Cancer and Leukemia Group B 9480. Clin Cancer Res. 2001; 7:1932.

62. Kantoff PW, Halabi S, Farmer DA, Hayes DF, Vogelzang NA, and Small EJ. Prognostic significance of reverse transcriptase polymerase chain reaction for prostate-specific antigen in men with hormone-refractory prostate cancer. J Clin Oncol. 2001; 19:3025.

63. Bok RA, Halabi S, Fei DT, Rodriquez CR, Hayes DF, Vogelzang NJ, Kantoff P, Shuman MA, and Small EJ. Vascular endothelial growth factor and basic fibroblast growth factor urine levels as predictors of outcome in hormone-refractory prostate cancer patients: a Cancer and Leukemia Group B study. Cancer Res. 2001; 61:2533.

64. Bast RC Jr, Ravdin P, Hayes DF, Bates S, Fritsche H Jr, Jessup JM, Kemeny N, Locker GY, Mennel RG, and Somerfield MR. 2000 Update of recommendations for the use of tumor markers in breast and colorectal cancer: clinical practice guidelines of the American Society of Clinical Oncology. J Clin Oncol. 2001; 19:1865. (Practice Guidelines).

65. Hayes DF, Yamauchi H, Broadwater G, Cirrincione C, Rodrigue S, Berry D, Younger J, Panasci L, Millard F, Duggan D, Norton L, and Henderson IC. Circulating HER-2 extracellular domain (ECD/HER-2) as a prognostic factor in patients with metastatic breast cancer: Cancer and Leukemia Group B study 8662. Clin Cancer Res. 2001; 7(9):2703–2711. Review.

66. Guidi AJ, Berry D, Broadwater G, Helmchen B, Bleiweiss I, Budman D, Henderson IC, Norton L, and Hayes DF. Association of angiogenesis and disease outcome in node-positive breast cancer patients treated with adjuvant CAF chemotherapy: A CALGB correlative science study from protocols 8541/8869. J Clin Oncol. 2002; 20(3):732–742.

67. Stearns V, Ewing CA, Slack R., Penannen MF, Hayes DF, and Tsangaris TN. Sentinel lymphadenectomy after neoadjuvant chemotherapy for breast cancer may reliably represent the axilla except for inflammatory breast cancer. Ann Surg Oncol. 2002; 9(3):235–242.

68. Ellis M, Davis N, Coop A, Liu M, Schumaker L, Lee RY, Srikanchana R, Russell CG, Singh B, Miller WR, Stearns V, Pennanen M, Tsangaris T, Gallagher A, Liu A, Zwart A, Hayes DF, Lippman ME, Wang Y, and Clarke R. Development and validation of a method for using breast core needle biopsies for gene expression microarray analyses. Clin Cancer Res. 2002; 8:1155–1166.

69. Buzdar A, Hayes DF, El-Khoudary A, Yan S, Ponning P, Lichinitser M, Gopal R, Falkson G, Pritchard K, Lipton A, Wolter K, Lee A, Fly K, Chew R, Alderdice M, Burke K, and Eisenberg P. Phase III randomized trial of droloxifene and tamoxifen as first-line endocrine treatment of ER/PgR-positive advanced breast cancer. Breast Cancer Res Treat. 2002; 73:161–175.

70. Hayes DF, Walker TM, Singh B, Vitetta ES, Uhr JW, Gross J, Rao C, Doyle GV, and Terstappen LWMM. Monitoring expression of HER-2 on circulating epithelial cells in patients with advanced breast cancer. Intl J Oncol. 2002;21:1111–1117.

71. Stearns V, Ullmer L, Lo’pez JF, Smith Y, Isaacs C and Hayes DF. Hot flushes: New prospects for and old problem. Lancet. 2002; 360:1851–1861. Review.

72. Stearns V, Singh B, Tsangaris T, Crawford JG, Novielli A, Ellis MJ, Isaacs C, Pennanen M, Tibery C, Farhad A, Slack R, and Hayes DF. A prospective randomized pilot study to evaluate predictors of response in serial core biopsies to single agent neoadjuvant Doxorubicin or Paclitaxel for patients with locally advanced breast cancer. Clin Cancer Res. 2003; 9:124–133.

73. Halabi S, Small EJ, Hayes DF, Vogelzang NJ, and Kantoff PW. Prognostic significance of reverse transcriptase polymerase chain reaction for prostate-specific antigen in metastatic prostate cancer: A nested study within CALGB 9583. J Clin Oncol. 2003; 21:490–495.

74. Henderson CI, Berry DA, Demetri GD, Cirrincione CT, Goldstein LJ, Martino S, Ingle JN, Frei E, Schilsky RL, Wood WC, Muss HB, Norton L, Duggan DV, Hayes DF, Cooper R, Tkaczuk KH, Fleming G, Holland JF, and Carpenter JT. Improved disease-free and overall survival from the addition of sequential paclitaxel but not from the escalation of doxorubicin dose in an adjuvant chemotherapy regimen for patients with node positive primary breast cancer. J Clin Oncol. 2003; 21:976–983.

75. Esteva FJ, Glaspy J, Baidas S, Laufman L, Hutchins L, Dickler M, Tripathy D, Cohen R, DeMichelle A, Yocum R, Osborne CK, Hayes DF, Hortobagyi GN, Winer E and Demetri G. Multicenter phase II study of oral bexarotene (Targretin) for patients with metastatic breast cancer. J Clin Oncol. 2003; 21:999–1006.

76. Sabel MS, Schott AF, Kleer CG, Merajver S, Cimmino VM, Diehl DM, Hayes DF, Chang AE, and Pierce LJ. Sentinel node biopsy prior to neoadjuvant chemotherapy. The American Journal of Surgery. 2003; 186:102–105.

77. Taplin ME, Rajeshkumar B, Halabi, Werner CP, Woda BA, Picus J, Stadler W, Hayes DF, Kantoff PW, Vogelzang NJ, and Small EJ. Androgen receptor mutations in androgen-independent prostate cancer: Cancer and Leukemia Group B Study 9663. J Clin Oncol. 2003; 21:2673–2678.

78. Ellmen J, Hakulinen P, Partanen A, and Hayes DF. Estrogenic effects of toremifene and tamoxifen in postmenopausal breast cancer patients. Breast Cancer Res Treat. 2003; 82:103–111.

79. Stearns V, Johnson MD, Rae JM, Morocho A, Novielli A, Bhargava P, Hayes DF, Desta C, and Flockhart DA. Active tamoxifen metabolite plasma concentrations after coadministration of tamoxifen and the selective serotonin reuptake inhibitor paroxetine. J Natl Cancer Inst. 2003; 95:1758–1764. PMID: 14652237.

80. Degnim AC, Griffith KA, Sabel MS, Hayes DF, Cimmino VM, Diehl KM, Lucas PC, Snyder ML, Chang AE, and Newman LA. Clinopathologic features of metastasis in nonsentinel lymph nodes of breast carcinoma patients. Cancer. 2003; 98:2307–2315.

81. Kleer CG, Cao Q, Varambally S, Shen R, Ota I, Tomlins SA, Ghosh D, Sewalt, RG, Otte AP, Hayes DF, Sabel MS, Livant D, Weiss SJ, Rubin MA, and Chinnaiyan AM. EZH2 is a marker of aggressive breast cancer and promotes neoplastic transformation of breast epithelial cells. Proc Natl Acad Sci, U S A. 2003; 100:11606–11611. PMID: 14500907.

82. Singer EA, Warren RD, Pennanen MF, Collins BT, and Hayes DF. Tamoxifen-Induced radiation recall dermatitis. Breast J. 2004; 10:170–171.

83. Cristofanilli M, Budd GT, Ellis MJ, Stopeck A, Matera J, Miller MC, Reuben JM., Doyle GV, Allard WJ, Terstappen LW, and Hayes DF. Circulating tumor cells, disease progression, and survival in metastatic breast cancer. N Engl J Med. 2004 Aug 19; 351(8):781–791.

84. Marshall J, Chen H, Yang D, Figueira M, Bouker KB, Ling Y, Lippman M, Frankel SR, and Hayes DF. A phase I trial of a Bcl-2 antisense (G3139) and weekly docetaxel in patients with advanced breast cancer and other solid tumors. Ann Oncol. 2004; 15(8):1274–1283.

85. Stearns V, Gallagher A, Kleer CG, Singh B, Freedman M, Haddad BR, Isaacs C, Warren R, Brown M, Cullen J, Trock B, and Hayes DF. A pilot study to establish a clinical model to perform phase II studies of breast cancer chemopreventive agents in women at high risk with biomarkers as surrogate endpoints for activity. Clin Cancer Res. 2004; 10(24)8332–8340.

86. Stearns V, Coop A, Singh B, Gallagher A, Yamauchi H, Lieberman R, Pennanen M, Trock B, Hayes DF, Ellis MJ. A pilot surrogate end point biomarker trial of perillyl alcohol in breast neoplasia. Clin Cancer Res. 2004; 10(22):7583–7591.

87. Chen SL, Clark S, Pierce LJ, Hayes DF, Helvie MA, Greeno PL, Newman LA, and Chang AE. An academic health center cost analysis of screening mammography: creating a financially viable service. Cancer. 2004; 101(5):1043–1050.

88. Cristofanilli M, Hayes DF, Budd GT, Ellis MJ, Stopeck A, Reuben JM, Doyle GV, Matera J, Allard WJ, Miller MC, Fritsche HA, Hortobagyi GN, and Terstappen LW. Circulating tumor cells: a novel prognostic factor for newly diagnosed metastatic breast cancer. J Clin Oncol. 2005; 23(7):1420–1430. PMID: 15735118.

89. Jin Y, Desta Z, Stearns V, Ward B, Ho H, Lee K, Skaar T, Storniolo AM, Li L, Araba A, Blanchard R, Nguyen A, Ullmer L, Hayden J, Lemler S, Weinshilboum RM, Rae JM, Hayes DF, and Flockhart DA. Differential effects of CYP2D6 genotype and antidepressants on tamoxifen metabolism. J Natl Cancer Inst. 2005; 97:30–39. PMID: 15632378.

90. Dressler LG, Berry DA, Broadwater G, Cowan D, Cox K, Griffin S, Miller A, Tse J, Novotny D, Persons DL, Barcos M, Henderson IC, Liu ET, Thor A, Budman D, Muss H, Norton L, and Hayes DF. Comparison of HER2 status by fluorescence in situ hybridization and immunohistochemistry of predict benefit from dose escalation of adjuvant doxorubicin-based therapy in node-positive breast cancer patients. J Clin Oncol. 2005; 23:4287–4297. PMID: 15994142.

91. Khan A, Sabel MS, Nees A, Diehl KM, Cimmino VM, Kleer CG, Schott AF, Hayes DF, Chang AE, and Newman LA. Comprehensive axillary evaluation in neoadjuvant chemotherapy patients with unltrasonography and sentinel lymph node biopsy. Ann Surg Oncol. 2005; 12:1–8.

92. Stearns V, Slack R, Greep N, Henry-Tilman R, Osborne M, Bunnell C, Ullmer L, Gallagher A, Cullen J, Gehan E, Hayes DF, and Isaacs C. Paroxetine is an effective treatment for hot flashes: Results from a prospective randomized clinical trial. J Clin Oncol. 2005; 23:6919–6930.

93. Isaacs C, Slack R, Heahn E, Ballen K, Boccia R, Areman E, Kramer R, Hayes DF, Herscowitz H, and Lippman M. A multicenter randomized clinical trial evaluating interleukin-2 activated hematopoietic stem cell transplantation and post-transplant IL-2 for high risk breast cancer patients. Breast Cancer Res Treat. 2005; 93:125–134.

94. Schott AF, Roubidoux MA, Helvie MA, Hayes DF, Kleer CG, Newman LA, Pierce LJ, Griffith KA, Murray S, Hunt KA, Paramagul C, and Baker LH. Clinical and radiologic assessments to predict breast cancer pathologic complete response to neoadjuvant chemotherapy. Breast Cancer Res Treat. 2005; 92:231–238.

95. Hayes DF, Cristofanilli M, Budd GT, Ellis MJ, Stopeck A, Miller MC, Matera J, Allard WJ, Doyle GV, and Terstappen LW. Circulating tumor cells at each follow-up time point during therapy of metastatic breast cancer patients predict progression-free and overall survival. Clin Cancer Res. 2006 Jul 15; 12(14 Pt 1):4218–4224. PMID: 16857794.

96. Smith IE, Dowsett M, Yap YS, Walsh G, Lonning PE, Santen RJ, Hayes D. Adjuvant aromatase inhibitors for early breast cancer after chemotherapy-induced amenorrhoea: caution and suggested guidelines. J Clin Oncol. 2006 Jun 1; 24(16):2444–2447. PMID: 16735701.

97. Schott A, Rae RM, Griffith KA, Hayes DF, Stearns V, Baker LH. Combination vinorelbine and capecitabine for metastatic breast cancer using a non-body surface area dosing scheme. Cancer Chemother Pharmacol. 2006 Jul; 58(1):129–135. Epub 2005 Nov 8. PMID: 16283312.

98. Borges S, Desta Z, Li L, Skaar TC, Ward BA, Nguyen A, Jin Y, Storniolo AM, Nikoloff DM, Wu L, Hillman G, Hayes DF, Stearns V, Flockhart DA. Quantitative effect of CYP2D6 genotype and inhibitors on tamoxifen metabolism: implication for optimization of breast cancer treatment. Clin Pharmacol Ther. 2006 Jul; 80(1):61–74. PMID: 16815318.

99. Hird RB, Chang A, Cimmino V, Diehl K, Sabel M, Kleer C, Helvie M, Schott A, Young J, Hayes D, Newman L. Impact of estrogen receptor expression and other clinicopathologic features on tamoxifen use in ductal carcinoma in situ. Cancer. 2006; 106(10):2113–2118. PMID: 16596655.

100. Budd GT, Cristofanilli M, Ellis MJ, Stopeck A, Borden E, Miller MC, Matera J, Repollet M, Doyle GV, Terstappen LW, Hayes DF. Circulating tumor cells versus imaging—predicting overall survival in metastatic breast cancer. Clin Cancer Res. 2006 Nov 1; 12(21):6403–6409. PMID: 17085652.

101. Porter PL, Barlow WE, Yeh IT, Lin MG, Yuan XP, Donato E, Sledge GW, Shapiro CL, Ingle JN, Haskell CM, Albain KS, Roberts JM, Livingston RB, Hayes DF. p27(Kip1) and cyclin E expression and breast cancer survival after treatment with adjuvant chemotherapy.

J Natl Cancer Inst. 2006 Dec 6;98(23):1723–1731. PMID: 17148774.

102. Harris LN, Broadwater G, Lin NU, Miron A, Schnitt SJ, Cowan D, Lara J, Bleiweiss I, Berry D, Ellis M, Hayes DF, Winer EP, Dressler L; Cancer and Leukemia Group B (CALGB). Molecular subtypes of breast cancer in relation to paclitaxel response and outcomes in women with metastatic disease: results from CALGB 9342. Breast Cancer Res. 2006;8(6):R66. PMID: 17129383.

103. Locker GY, Hamilton S, Harris J, Jessup JM, Kemeny N, Macdonald JS, Somerfield MR, Hayes DF, Bast RC Jr; ASCO. ASCO 2006 update of recommendations for the use of tumor markers in gastrointestinal cancer. J Clin Oncol. 2006 Nov 20; 24(33):5313–5327. Epub 2006 Oct 23. PMID: 17060676. (Practice Guidelines; Dr. Hayes is co-chair of the committee with Dr. Bast).

104. Newman EA, Guest AB, Helvie MA, Roubidoux MA, Chang AE, Kleer CG, Diehl KM, Cimmino VM, Pierce L, Hayes D, Newman LA, Sabel MS. Changes in surgical management resulting from case review at a breast cancer multidisciplinary tumor board. Cancer. 2006 Nov 15; 107(10):2346–2351. PMID: 16998942.

105. Wolff AC, Hammond ME, Schwartz JN, Hagerty KL, Allred DC, Cote RJ, Dowsett M, Fitzgibbons PL, Hanna WM, Langer A, McShane LM, Paik S, Pegram MD, Perez EA, Press MF, Rhodes A, Sturgeon C, Taube SE, Tubbs R, Vance GH, van de Vijver M, Wheeler TM, Hayes DF. American Society of Clinical Oncology; College of American Pathologists. American Society of Clinical Oncology/College of American Pathologists Guideline Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer. J Clin Oncol. 2007 Jan 1; 25(1):118–145. (Practice Guidelines). Epub 2006 Dec 11. PMID: 17159189.

[Published simultaneously in Arch Pathol Lab Med. 2007 Jan 1; 131(1):18.[Epub ahead of print]. PMID: 17228981.

106. Layman RM, Thomas DG, Griffith KA, Smerage JB, Helvie MA, Roubidoux MA, Diehl KM, Newman LA, Sabel MS, Hayman JA, Pierce LJ, Hayes DF, Schott AF. Neoadjuvant docetaxel and capecitabine and the use of thymidine phosphorylase as a predictive biomarker in breast cancer. Clin Cancer Res. 2007. Jul 15;13(14):4092–7. PMID: 17634534.

107. Newman EA, Sabel MS, Nees AV, Schott A, Diehl KM, Cimmino VM, Chang AE, Kleer C, Hayes DF, Newman LA. Sentinel lymph node biopsy performed after neoadjuvant chemotherapy is accurate in patients with documented node-positive breast cancer at presentation. Ann Surg Oncol. 2007 Oct;14(10):2946–52. PMID: 17514407.

108. Hayes DF, Thor AD, Dressler LG, Weaver D, Edgerton S, Cowan D, Broadwater G, Goldstein LJ, Martino S, Ingle JN, Henderson IC, Norton L, Winer EP, Hudis CA, Ellis MJ, Berry DA; Cancer and Leukemia Group B (CALGB) Investigators. HER2 and response to paclitaxel in node-positive breast cancer. N Engl J Med. 2007 Oct 11;357(15):1496–506. PMID: 17928597.

109. Harris L, Frische H, Mennel R, Norton L, Ravdin P, Taube S, Somerfield MR, Hayes DF, Bast RC Jr; American Society of Clinical Oncology 2007 update of recommendations for the use of tumor markers in breast cancer. J Clin Oncol 2007 Nov 20;25(33):5287–312. PMID: 17954709. (Practice Guidelines; Dr. Hayes is co-chair of the committee with Dr. Bast).

110. Dowsett M, Goldhirsch A, Hayes DF, Senn HJ, Wood W,Viale G. International Web-based consultation on priorities for translational breast cancer research. Breast Cancer Res. 2007;9(6):R81. PMID: 18034879. PMCID: PMC2246180.

111. Ntukidem NI, Nguyen AT, Stearns V, Rehman M, Schott A, Skaar T, Jin Y, Blanche P, Li L, Lemler S, Hayden J, Krauss RM, Desta Z, Flockhart DA, Hayes DF; Consortium on Breast Cancer Pharmacogenomics. Estrogen receptor genotypes, menopausal status, and the lipid effects of tamoxifen. Clin Pharmacol Ther. 2008. May;83(5):702–10. PMID: 17713466. PMCID: PMC2782693.

112. Liu MC, Demetri GD, Berry DA, Norton L, Broadwater G, Robert NJ, Duggan D, Hayes DF, Henderson IC, Lyss A, Hopkins J, Kaufman PA, Marcom PK, Younger J, Lin N, Tkaczuk K, Winer EP, Hudis CA; Cancer and Leukemia Group B (CALGB). Dose-escalation of filgrastim does not improve efficacy: clinical tolerability and long-term follow-up on CALGB study 9141 adjuvant chemotherapy for node-positive breast cancer patients using dose-intensified doxorubicin plus cyclophosphamide followed by paclitaxel. Cancer Treat Rev. 2008 May; 34(3):223–30. PMID: 18234424. PMCID: PMC2651678.

113. DiGiovanna MP, Stern DF, Edgerton S, Broadwater G, Dressler LG, Budman DR, Henderson IC, Norton L, Liu ET, Muss HB, Berry DA, Hayes DF, Thor AD. Influence of activation state of ErbB-2 (HER-2) on response to adjuvant cyclophosphamide, doxorubicin, and fluorouracil for stage II, node-positive breast cancer: study 8541 from the Cancer and Leukemia Group B (CALGB). J Clin Oncol. 2008 May 10;26(14): 2364–72. PMID: 18390970.

114. Gonzalez RM, Seurynck-Servoss SL, Crowley SA, Brown M, Omenn GS, Hayes DF, Zangar RC. Development and validation of sandwich ELISA microarrays with minimal assay interference. J Proteome Res. 2008 Jun;7(6):2406–14. PMID: 18422355.

115. Eliane JP, Repollet M, Luker KE, Brown M, Rae JM, Dontu G, Schott AF, Wicha M, Doyle GV, Hayes DF, Luker GD. Monitoring serial changes in circulating human breast cancer cells in murine xenograft models. Cancer Res. 2008. Jul 15;68(14): 5529–32. PMID: 18632603. PMCID: PMC2789403.

116. Sturgeon CM, Hofmann BR, Chan DW, Ch’ng SL, Hammond E, Hayes DF, Liotta LA, Petricoin EF, Schmitt M, Semmes OJ, Söletormos G, van der Merwe E, Diamandis EP; National Academy of Clinical Biochemistry. National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines for use of tumor markers in clinical practice: quality requirements. Clin Chem. 2008. Aug;54(8):e1-e10. PMID: 18606634. (Note: Dr. Hayes was a critical member of the Guidelines Committee and co-authored a major section of it.)

117. Henry NL Giles JT Ang D, Mohan M, Dadabhoy D, Robarge J, Hayden J, Lemler S, Shahverdi K, Powers P, Li L, Flockhart D, Stearns V, Hayes DF, Storniolo AM, Clauw DJ. Prospective characterization of musculoskeletal symptoms in early stage breast cancer patients treated with aromatase inhibitors. Breast Cancer Res Treat. 2008 Sep;111(2):365–72. PMID: 17922185.

118. Contreras-Galindo R, Kaplan MH, Leissner P, Verjat T, Ferlenghi I, Bagnoli F, Giusti F, Dosik MH, Hayes DF, Gitlin SD, Markovitz DM. Human endogenous retrovirus-K (HML-2) elements in the plasma of people with lymphoma and breast cancer. J Virol. 2008. Oct; 82(19):9329–36. PMID: 18632860. PMCID: PMC2546968.

119. Kilbride KE, Lee MC, Nees AV, Cimmino VM, Diehl KM, Sabel MS, Hayes DF, Schott AF, Kleer CG, Chang AE, Newman LA. Axillary staging prior to neoadjuvant chemotherapy for breast cancer: predictors of recurrence. Ann Surg Oncol. 2008 Nov;15(11):3252–8. PMID: 18784961.

120. Sturgeon CM, Duffy MJ, Stenman UH, Lilja H, Brünner N, Chan DW, Babian R, Bast RC Jr, Dowell B, Esteva FJ, Haglund C, Harbeck N, Hayes DF, Holten-Andersen M, Klee GG, Lamerz R, Looijenga LH, Molina R, Nielsen HJ, Rittenhouse H, Semjonow A, Shih leM, Sibley P, Sölétormos G, Stephan C, Sokoll L, Hoffman BR, Diamandis EP; National Academy of Clinical Biochemistry. National Academy of Clinical Biochemistry laboratory medicine practice guidelines for use of tumor markers in testicular, prostate, colorectal, breast, and ovarian cancers. Clin Chem. 2008 Dec; 54(12):e11–79. PMID: 19042984. (Note: Dr. Hayes was a critical member of the Guidelines Committee and co-authored a major section of it.)

121. Jin Y, Hayes DF, Li L, Robarge JD, Skaar TC, Philips S, Nguyen A, Schott A, Hayden J, Lemler S, Storniolo AM, Flockhart DA, Stearns V. Estrogen receptor genotypes influence hot flash prevalence and composite score before and after tamoxifen therapy. J Clin Oncol. 2008 Dec 20;26(36):5849–54. PMID: 19018086. PMCID: PMC2645113.

122. Chew HK, Barlow WE, Albain K, Lew D, Gown A, Hayes DF, Gralow J, Hortobagyi GN, Livingston R. A phase II study of imatinib mesylate and capecitabine in metastatic breast cancer: Southwest Oncology Group Study 0338. Clin Breast Cancer. 2008 Dec;8(6):511–5. PMID:19073506.

123. Lester SC, Bose S, Chen YY, Connolly JL, de Baca ME, Fitzgibbons PL, Hayes DF, Kleer C, O’Malley FP, Page DL, Smith BL, Weaver DL, Winer E; Members of the Cancer Committee, College of American Pathologists. Protocol for the examination of specimens from patients with ductal carcinoma in situ of the breast. Arch Pathol Lab Med. 2009 Jan; 133(1):15–25. PMID: 19123730.

124. Carlson RW, Allred DC, Anderson BO, Burstein HJ, Carter WB, Edge SB, Erban JK, Farrar WB, Goldstein LJ, Gradishar WJ, Hayes DF, Hudis CA, Jahanzeb M, Kiel K, Ljung BM, Marcom PK, Mayer IA, McCormick B, Nabell LM, Pierce LJ, Reed EC, Smith ML, Somlo G, Theriault RL, Topham NS, Ward JH, Winer EP, Wolff AC; NCCN Breast Cancer Clinical Practice Guidelines Panel. Breast cancer. Clinical practice guidelines in oncology. J Natl Compr Canc Netw. 2009 Feb;7(2):122–92. PMID: 19200416.

(Note: Dr. Hayes is a standing member of the panel.)

125. Allegra CJ, Jessup JM, Somerfield MR, Hamilton SR, Hammond EH, Hayes DF, McAllister PK, Morton RF, Schilsky RL. American Society of Clinical Oncology provisional clinical opinion: testing for KRAS gene mutations in patients with metastatic colorectal carcinoma to predict response to anti-epidermal growth factor receptor monoclonal antibody therapy. J Clin Oncol. 2009 Apr 20;27(12):2091–6. PMID: 19188670. (Note: Dr. Hayes was a critical member of the deliberations committee.)

126. Rhodes DR, Ateeq B, Cao Q, Tomlins SA, Mehra R, Laxman B, Kalyana-Sundaram S, Lonigro RJ, Helgeson BE, Bhojani MS, Rehemtulla A, Kleer CG, Hayes DF, Lucas PC, Varambally S, Chinnaiyan AM. AGTR1 overexpression defines a subset of breast cancer and confers sensitivity to losartan, an AGTR1 antagonist. Proc Natl Acad Sci U S A. 2009 Jun 23;106(25):10284–9. PMID: 19487683. PMCID: PMC2689309.

127. Harris LN, Broadwater G, Abu-Khalaf M, Cowan D, Thor AD, Budman D, Cirrincione CT, Berry DA, Winer EP, Hudis CA, Hayes DF, Friedman P, Ellis M, Dressler L. Topoisomerase II{alpha} amplification does not predict benefit from dose-intense cyclophosphamide, doxorubicin, and fluorouracil therapy in HER2-amplified early breast cancer: results of CALGB 8541/150013. J Clin Oncol. 2009 Jul 20;27(21):3430–6. PMID: 19470942.

128. Rae JM, Sikora MJ, Henry NL, Li L, Kim S, Oesterreich S, Skaar TC, Nguyen AT, Desta Z, Storniolo AM, Flockhart DA, Hayes DF, Stearns V; COBRA investigators. Cytochrome P450 2D6 activity predicts discontinuation of tamoxifen therapy in breast cancer patients. Pharmacogenomics J. 2009 Aug;9(4):258–64. PMID: 19421167.

129. Choi JY, Barlow WE, Albain KS, Hong CC, Blanco JG, Livingston RB, Davis W, Rae JM, Yeh IT, Hutchins LF, Ravdin PM, Martino S, Lyss AP, Osborne CK, Abeloff MD, Hayes DF, Ambrosone CB. Nitric oxide synthase variants and disease-free survival among treated and untreated breast cancer patients in a Southwest Oncology Group clinical trial. Clin Cancer Res. 2009 Aug 15;15(16):5258–66. PMID: 19671875. PMCID: PMC2745926.

130. Tubbs R, Barlow WE, Budd GT, Swain E, Porter P, Gown A, Yeh IT, Sledge G, Shapiro C, Ingle J, Haskell C, Albain KS, Livingston R, Hayes DF. Outcome of patients with early-stage breast cancer treated with doxorubicin-based adjuvant chemotherapy as a function of HER2 and TOP2A status. J Clin Oncol. 2009 Aug 20;27(24):3881–6. PMID: 19620488. PMCID: PMC2734394.

131. Houssami N, Hayes DF. Review of preoperative magnetic resonance imaging (MRI) in breast cancer: should MRI be performed on all women with newly diagnosed, early stage breast cancer? CA Cancer J Clin. 2009 Sep–Oct;59(5):290–302. PMID: 19679690.

132. Henry NL, Rae JM, Li L, Azzouz F, Skaar TC, Desta Z, Sikora MJ. Philips S, Nguyen AT, Storniolo AM, Hayes DF, Flockhart DA, Stearns V; Consortium on Breast Cancer Pharmacogenomics Investigators. Association between CYP2D6 genotype and tamoxifen-induced hot flashes in a prospective cohort. Breast Cancer Res Treat. 2009 Oct; 117(3):571–5. PMID: 19153830. PMCID: PMC2746261.

133. Lester SC, Bose S, Chen YY, Connolly JL, de Baca ME, Fitzgibbons PL, Hayes DF, Kleer C, O’Malley FP, Page DL, Smith BL, Tan LK, Weaver DL, Winer E; Members of the Cancer Committee, College of American Pathologists. Protocol for the examination of specimens from patients with invasive carcinoma of the breast. Arch Pathol Lab Med. 2009 Oct;133(10):1515–38. PMID: 19792042.

134. Ambrosone CB, Barlow WE, Reynolds W, Livingston RB, Yeh IT, Choi JY, Davis W, Rae JM, Tang L, Hutchins LR, Ravdin PM, Martino S, Osborne CK, Lyss AP, Hayes DF, Albain KS. Myeloperoxidase genotypes and enhanced efficacy of chemotherapy for early-stage breast cancer in SWOG-8897. J Clin Oncol. 2009 Oct 20;27(30):4973–9. PMID: 19752340. PMCID: PMC2799053.

135. Simon RM, Paik S, Hayes DF. Use of archived specimens in evaluation of prognostic and predictive biomarkers. J Natl Cancer Inst. 2009 Nov 4;101(21):1446–52. PMID: 19815849. PMCID: PMC2782246.

136. Albain KS, Barlow WE, Shak S, Hortobagyi GN, Livingston RB, Yeh IT, Ravdin P, Bugarini R, Baehner FL, Davidson NE, Sledge GW, Winer EP, Hudis C, Ingle JN, Perez EA, Pritchard KI, Shepherd L, Gralow JR, Yoshizawa C, Allred DC, Osborne CK, Hayes DF; Breast Cancer Intergroup of North America. Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial. Lancet Oncol. 2010 Jan;11(1):55–65. PMID: 20005174. PMCID: PMC3058239.

137. Henry NL, Nguyen A, Azzouz F, Li L, Robarge J, Philips S, Cao D, Skaar TC, Rae JM, Storniolo AM, Flockhart DA, Hayes DF, Stearns V. Lack of association between oestrogen receptor polymorphisms and change in bone mineral density with tamoxifen therapy. Br J Cancer. 2010 Jan 19;102(2):294–300. PMID: 19953095. PMCID: PMC2816645.

138. Fagerlin A, Zikmund-Fisher BJ, Nair V, Derry HA, McClure JB, Greene S, Stark A, Hensley Alford S, Lantz P, Hayes DF, Wiese C, Claud Zweig S, Pitsch R, Jankovic A, Ubel PA. Women’s decisions regarding tamoxifen for breast cancer prevention: responses to a tailored decision aid. Breast Cancer Res Treat. 2010 Feb;119(3):613–20. PMID: 19908143.

139. Cimprich B, Reuter-Lorenz P, Nelson J, Clark PM, Therrien B, Normolle D, Berman MG, Hayes DF, Noll DC, Peltier S, Welsh RC. Prechemotherapy alterations in brain function in women with breast cancer. J Clin Exp Neuropsychol. 2010 Mar;32(3):324–31. PMID: 19642048.

140. Yao S, Barlow WE, Albain KS, Choi JY, Zhao H, Livingston RB, Davis W, Rae JM, Yeh IT, Hutchins LF, Ravdin PM, Martino S, Lyss AP, Osborne CK, Abeloff MD, Hortobagyi GN, Hayes DF, Ambrosone CB. Manganese superoxide dismutase polymorphism, treatment-related toxicity and disease-free survival in SWOG 8897 clinical trial for breast cancer. Breast Cancer Res Treat. 2010 Mar 23. [Epub ahead of print]. PMID: 20309628.

141. Lo SS, Mumby PB, Norton J, Rychlik K, Smerage J, Kash J, Chew HK, Gaynor ER, Hayes DF, Epstein A, Albain KS. Prospective multicenter study of the impact of the 21-gene recurrence score assay on medical oncologist and patient adjuvant breast cancer treatment selection. J Clin Oncol. 2010 Apr 1; 28(10):1671–6. PMID: 20065191.

142. Harigopal M, Barlow WE, Tedeschi G, Porter PL, Yeh IT, Haskell C, Livingston R, Hortobagyi GN, Sledge G, Shapiro C, Ingle JN, Rimm DL, Hayes DF. Multiplexed assessment of the Southwest Oncology Group-directed Intergroup Breast Cancer Trial S9313 by AQUA shows that both high and low levels of HER2 are associated with poor outcome. Am J Pathol 2010 Apr; 176(4):1639–47. PMID: 20150438. PMCID: PMC2843456.

143. Hammond ME, Hayes DF, Dowsett M, Alfred DC, Hagerty KL, Badve S, Fitzgibbons PL, Francis G, Goldstein NS, Hayes M, Hicks DG, Lester S, Love R, Mangu PB, McShane L, Miller K, Osborne CK, Paik S, Perlmutter J, Rhodes A, Sasano H, Schwartz JN, Sweep FC, Taube S, Torlakovic EE, Valenstein P, Viale G, Visscher D, Wheeler T, Williams RB, Wittliff JL, Wolff AC. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer. J Clin Oncol. 2010 Jun 1;28(16):2784–95. PMID: 20404251. PMCID: PMC2881855. (Note: Dr. Hayes served as co-chair of the committee that developed these guidelines.)

[Published simultaneously in Arch Pathol Lab Med. 2010 Jun;134(6):907–22. PMID: 20524868.]

144. Gilligan TD, Seidenfeld J, Basch EM, Einhorn LH, Fancher T, Smith DC, Stephenson AJ, Vaughn DJ, Cosby R, Hayes DF; American Society of Clinical Oncology. American Society of Clinical Oncology Clinical Practice Guideline on uses of serum tumor markers in adult males with germ cell tumors. J Clin Oncol. 2010 Jul 10;28(20):3388–404. PMID: 20530278.

145. Henry NL, Pchejetski D, A’Hern R, Nguyen AT, Charles P, Waxman J, Li L, Storniolo AM, Hayes DF, Flockhart DA, Stearns V, Stebbing J. Inflammatory cytokines and aromatase inhibitor-associated musculoskeletal syndrome: a case-control study. Br J Cancer. 2010 Jul 27;103(3):291–6. PMID: 20606683. PMCID: PMC2920022.

146. Henry NL, Jacobson JA, Banerjee M, Hayden J, Smerage JB, Van Poznak C, Storniolo AM, Stearns V, Hayes DF. A prospective study of aromatase inhibitor-associated musculoskeletal symptoms and abnormalities on serial high-resolution wrist ultrasonography. Cancer. 2010 Sep 15;116(18):4360-7. PMID: 20549827. PMCID: PMC2936686.

147. Hayes DF, Skaar TC, Rae JM, Henry NL, Nguyen AT, Stearns V, Li L, Philips S, Desta Z, Flockhart DA; Consortium on Breast Cancer Pharmacogenomics (COBRA). Estrogen receptor genotypes, menopausal status, and the effects of tamoxifen on lipid levels: revised and updated results. Clin Pharmacol Ther. 2010 Nov;88(5):626-9. PMID: 20827267. NIHMSID#346982.

148. Carlson RW, Allred DC, Anderson BO, Burstein HJ, Carter WB, Edge SB, Erban JK, Farrar WB, Forero A, Giodano SH, Goldstein LJ, Gradishar WJ, Hayes DF, Hudis CA, Ljung BM, Marcom PK, Mayer IA, McCormick B, Pierce LJ, Reed EC, Smith ML, Somlo G, Topham NS, Ward JH, Winer EP, Wolff AC. Breast cancer: noninvasive and special situations. J Natl Compr Canc Netw. 2010 Oct;8(10):1182-207. PMID: 20971842.

149. Yao S, Barlow WE, Albain KS, Choi JY, Zhao H, Livingston RB, Davis W, Rae JM, Yeh IT, Hutchins LF, Ravdin PM, Martino S, Lyss AP, Osborne CK, Abeloff M, Hortobagyi GN, Hayes DF, Ambrosone CB. Gene polymorphisms in cyclophosphamide metabolism pathway, treatment-related toxicity, and disease-free survival in SWOG 8897 clinical trial for breast cancer. Clin Cancer Res. 2010 Dec 15;16(24):6169-76. PMID: 21169260. PMCID: PMC3058716.

150. Carlson RW, Allred DC, Anderson BO, Burstein HJ, Carter WB, Edge SB, Erban JK, Farrar WB, Forero A, Giodano SH, Goldstein LJ, Gradishar WJ, Hayes DF, Hudis CA, Ljung BM, Mankoff DA, Marcom PK, Mayer IA, McCormick B, Pierce LJ, Reed EC, Sachdev J, Smith ML, Somlo G, Ward JH, Wolff AC, Zellars R. Invasive breast cancer. J Natl Compr Canc Netw. 2011 Feb;9(2):136-222. PMID: 21310842.

151. Fagerlin A, Dillard AJ, Smith DM, Zikmumnd-Fisher BJ, Pitsch R, McClure JB, Greene S, Hensley Alford S, Nair V, Hayes DF, Wiese C, Ubel PA. Women’s interest in taking tamoxifen and raloxifene for breast cancer prevention: response to a tailored decision aid. Breast Cancer Res Treat. 2011 Jun;127(3):681-688. PMID: 21442198.

152. Andre F, McShane LM, Michiels S, Ransohoff DF, Altman DG, Reis-Filho JS, Hayes DF, Pusztai L. Biomarker studies: a call for a comprehensive biomarker study registry. Nat Rev Clin Oncol. 2011 Mar;8(3):171-6. PMID: 21364690.

153. Moore HM, Kelly AB, Jewell SD, McShane LM, Clark DP, Greenspan R, Hayes DF, Hainaut P, Kim P, Mansfield EA, Potapova O, Riegman P, Rubinstein Y, Seijo E, Somiari S, Watson P, Weier HU, Zhu C, Vaught J. Biospecimen reporting for improved study quality (BRISQ). Cancer Cytopathol. 2011 Apr 25;119(2):92-102. PMID: 21433001. * PMCID: PMC3169291.

*This article is being published simultaneously in Biopreservation and Biobanking by Mary Ann Liebert, Inc. Publishers; Journal of Proteome Research by American Chemical Society Publications; and Cancer Cytopathology by Wiley-Blackwell, on behalf of the American Cancer Society.

154. Sucheston LE, Zhao H, Yao S, Zirpoli G, Liu S, Barlow WE, Moore HC, Thomas Budd G, Hershman DL, Davis W, Ciupak GL, Stewart JA, Isaacs C, Hobday TJ, Salim M, Hortobagyi GN, Gralow JR, Livingston RB, Albain KS, Hayes DF, Ambrosone CB. Genetic predictors of taxane-induced neurotoxicity in a SWOG phase III intergroup adjuvant breast cancer treatment trial (S0221). Breast Cancer Res Treat. 2011 Dec;130(3):993-1002. PMID: 21766209. PMCID: PMC3532924.

155. Lara JF, Thor AD, Dressler LG, Broadwater G, Bleiweiss IJ, Edgerton S, Cowan D, Goldstein LJ, Martino S, Ingle JN, Henderson IC, Norton L, Winer EP, Hudis CA, Ellis MJ, Berry DA, Hayes DF; for the Cancer and Leukemia Group B. p53 expression in node-positive breast cancer patients: Results from the Cancer and Leukemia Group B 9344 trial (159905). Clin Cancer Res. 2011 Aug 1;17(15):5170-5178. PMID: 21693655. PMCID: PMC3149770.

156. Henry NL, Banerjee M, Wicha M, Van Poznak C, Smerage JB, Schott AF, Griggs JJ, Hayes DF. Pilot study of duloxetine for treatment of aromatase inhibitor-associated musculoskeletal symptoms. Cancer. 2011 Dec 15;117(24):5469-75. PMID: 21692065.

157. Desta Z, Kreutz Y, Nguyen AT, Li L, Skaar T, Kamden LK, Henry NL, Hayes DF, Storniolo AM, Stearns V, Hoffmann E, Tyndale RF, Flockhart DA. Plasma letrozole concentrations in postmenopausal women with breast cancer are associated with CYP2A6 genetic variants, body mass index, and age. Clin Pharmacol Ther. 2011 Nov;90(5):693-700. PMID: 21975350.

158. Bardia A, Arieas ET, Zhang Z, Defilippis A, Tarpinian K, Jeter S, Nguyen A, Henry NL, Flockhart DA, Hayes DF, Hayden J, Storniolo AM, Armstrong DK, Davidson NE, Fetting J, Ouyang P, Wolff AC, Blumenthal RS, Ashen MD, Stearns V. Comparison of breast cancer recurrence risk and cardiovascular disease incidence risk among postmenopausal women with breast cancer. Breast Cancer Res Treat. 2012 Feb;131(3):907-14. PMID: 22042368.

159. Dowsett M, Nielsen TO, A’hern R, Bartlett J, Coombes RC, Cuzick J, Ellis M, Henry NL, Hugh JC, Lively T, McShane L, Paik S, Penault-Llora F, Prudkin L, Regan M, Salter J, Sotiriou C, Smith IE, Viale G, Zujewski JA, Hayes DF. Assessment of Ki67 in breast cancer: Recommendations from the International Ki67 in Breast Cancer Working Group. J Natl Cancer Inst. 2011 Nov 16;103(22):1656-64. PMID: 21960707. PMCID: PMC3216967.

160. Djuric Z, Ellsworth JS, Weldon AL, Ren J, Richardson CR, Resnicow K, Newman LA, Hayes DF, Sen A. A diet and exercise intervention during chemotherapy for breast cancer. Open Obes J. 2011;3:87-97. PMID: 22238561. PMCID: PMC3253619.

161. Bell LN, Nguyen AT, Li L, Desta Z, Henry NL, Hayes DF, Wolff AC, Stearns V, Storniolo AM, Flockhart DA; (COBRA) The Consortium on Breast Cancer Pharmacogenomics. Comparison of changes in the lipid profile of postmenopausal women with early stage breast cancer treated with exemestane or letrozole. J Clin Pharmacol. 2012 Dec; 52(12):1852-1860. PMID: 22174434.

162. Hartmaier RJ, Richter AS, Gillihan RM, Sallit JZ, McGuire SE, Wang J, Lee AV, Osborne CK, O'Malley BW, Brown PH, Xu J, Skaar TC, Philips S, Rae JM, Azzouz F, Li L, Hayden J, Henry NL, Nguyen AT, Stearns V, Hayes DF, Flockhart DA, Oesterreich S. A SNP in steroid receptor coactivator-1 disrupts a GSK3β phosphorylation site and is associated with altered tamoxifen response in bone. Mol Endocrinol. 2012 Feb;26(2):220-7. PMID: 22174377. PMCID: PMC3275159.

163. Schott AF, Barlow WE, Albain KS, Chew HK, Wade JL 3rd, Lanier KS, Lew DL, Hayes DF, Gralow JR, Livingston RB, Hortobagyi GN. Phase II trial of simple oral therapy with capecitabine and cyclophosphamide in patients with metastatic breast cancer:SWOG S0430. Oncologist. 2012;17(2):179-87. PMID: 22267853. PMCID: PMC3286166.

164. Henry NL, Azzouz F, Desta Z, Li L, Nguyen AT, Lemler S, Hayden J, Tarpinian K, Yakim E, Flockhart DA, Stearns V, Hayes DF, Storniolo AM. Predictors of aromatase inhibitor discontinuation as a result of treatment-emergent symptoms in early stage breast cancer. J Clin Oncol. 2012 Mar 20;30(9):936-42. PMID: 22331951. PMCID: PMC3341106.

165. Philips S, Rae JM, Oesterreich S, Hayes DF, Stearns V, Henry NL, Storniolo AM, Flockhart DA, and Skaar TC. Whole genome amplification of DNA for genotyping pharmacogenetics candidate genes. Front. Pharmacol. 2012;3:54. PMID: 22479249 PMCID: PMC3315790 http://www.frontiersin.org/Journal/Abstract.aspx?s=860&name=pharmacogenetics%20and%20pharmacogenomics&ART_DOI=10.3389/fphar.2012.00054

166. Rae JM, Drury S, Hayes DF, Stearns V, Thibert JN, Haynes BP, Salter J, Sestak I, Cuzick J, Dowsett M; on behalf of the ATAC trialists. CYP2D6 and UGT2B7 genotype and risk of recurrence in tamoxifen-treated breast cancer patients. J Natl Cancer Inst. 2012 Mar 21;104(6):452-60. PMID: 22395643. PMCID: PMC3611934.

167. Carlson RW, Allred DC, Anderson BO, Burstein HJ, Edge SB, Farrar WB, Forero A, Giordano SH, Goldstein LJ, Gradishar WJ, Hayes DF, Hudis CA, Isakoff SJ, Ljung BM, Mankoff DA, Marcom PK, Mayer IA, McCormick B, Pierce LJ, Reed EC, Smith ML, Soliman H, Somlo G, Theriault RL, Ward JH, Wolff AC, Zellars R, Kumar R, Shead DA. Metastatic breast cancer, version 1.2012: featured updates to the NCCN guidelines. J Natl Compr Canc Netw. 2012 Jul 1;10(7):821-9. PMID: 22773798.

168. Mehta RS, Barlow WE, Albain KS, Vandenberg TA, Dakhil SR, Tirumali NR, Lew DL, Hayes DF, Gralow JR, Livingston RB, Hortobagyi GN. Combination anastrozole and fulvestrant in metastatic breast cancer. N Engl J Med. 2012 Aug 2;367(5):435-44. PMID: 22853014.

169. Wills S, Ravipati A, Venuturumilli P, Kresge C, Folkerd E, Dowsett M, Hayes DF, Decker DA. Effects of vaginal estrogens on serum estradiol levels in postmenopausal breast cancer survivors and women at risk of breast cancer taking an aromatase inhibitor or a selective estrogen receptor modulator. J Oncol Pract. 2012 May;8(3):144-8. PMID: 22942807. PMCID: PMC3396801.

170. Sölétormos G, Duff MJ, Hayes DF, Sturgeon CM, Barak V, Bossuyt PM, Diamandis EP, Gion M, Hyltoft-Petersen P, Lamerz RM, Nielsen DL, Sibley P, Tholander B, Tuxen MK, Bonfrer JM. Design of tumor biomarker-monitoring trials: A proposal by the European group on tumor markers. Clin Chem. 2013 Jan;59(1):52-9. PMID: 23034139.

171. McShane LM, Hayes DF. Publication of tumor marker research results: the necessity for complete and transparent reporting. J Clin Oncol. 2012 Dec 1;30(34):4223-32. PMID: 23071235. PMID: PMC3504327.

172. Wolff AC, Lazar AA, Bondarenko I, Garin AM, Brincat S, Chow L, Sun Y, Neskovic-Konstantinovic Z, Guimaraes RC, Fumoleau P, Chan A, Hachemi S, Strahs A, Cincotta M, Berkenblit A, Krygowski M, Kang LL, Moore L, Hayes DF. Randomized Phase III placebo-controlled trial of letrozole plus oral temsirolimus as first-line endocrine therapy in postmenopausal women with locally advanced or metastatic breast cancer. J Clin Oncol. 2013 Jan 10;31(2):195-202. PMID: 23233719. PMID: PMC3532391.

173. Northouse LL, Mood DW, Schafenacker A, Kalemkerian G, Zalupski M, Lorusso P, Hayes DF, Hussain M, Ruckdeschel J, Fendrick AM, Trask PC, Ronis DL, Kershaw T. Randomized clinical trial of a brief and extensive dyadic intervention for advanced cancer patients and their caregivers. Psychooncology. 2013 Mar;22(3):555-63. PMID: 22290823. PMCID: PMC3387514.

174. Ithimakin S, Day KC, Malik F, Zen Q, Dawsey SJ, Bersano-Begey TF, Quraishi AA, Ignatowski KW, Daignault S, Davis A, Hall CL, Palanisamy N, Heath AN, Tawakkol N, Luther TK, Clouthier SG, Chadwick WA, Day ML, Kleer CG, Thomas DG, Hayes DF, Korkaya H, Wicha MS. HER2 drives luminal breast cancer stem cells in the absence of HER2 amplification: implications for efficacy of adjuvant trastuzumab. Cancer Res. 2013 Mar 1;73(5):1635-46. PMID: 23442322. PMCID: PMC3600586.

175. Schott AF, Landis M, Dontu G, Griffith KA, Layman RM, Krop I, Paskett LA, Wong H, Drobolecki LE, Froehlich AM, Paranilam J, Hayes DF, Wicha MS, Chang JC. Preclinical and clinical studies of gamma secretase inhibitors with docetaxel on human breast tumors. Clin Cancer Res. 2013 March 15:19(6):1512-24. PMID: 23340294. PMCID: PMC3602220.

176. Smerage JB, Budd GT, Doyle GV, Brown M, Paoletti C, Muniz M, Miller MC, Repollet MI, Chianese DA, Connelly MC, Terstappen LW, Hayes DF. Monitoring apoptosis and Bcl-2 on circulating tumor cells in patients with metastatic breast cancer. Mol Oncol. 2013 Jun;7(3):680-92. PMID: 23538216. (No Federal Support cited).

177. Henry NL, Skaar TC, Dantzer J, Li L, Kidwell K, Gersch C, Nguyen AT, Rae JM, Desta Z, Oesterreich S, Philips S, Carpenter JS, Storniolo AM, Stearns V, Hayes DF, Flockhart DA. Genetic associations with toxicity-related discontinuation of aromatase inhibitor therapy for breast cancer. Breast Cancer Res Treat. 2013 Apr;138(3):807-16. PMID: 23546553. PMCID: PMC3646626.

178. Henry NL, Xia R, Banerjee M, Gersch C, McConnell D, Giacherio D, Schott AF, Pearlman M, Stearns V, Partridge AH, Hayes DF. Predictors of recovery of ovarian function during aromatase inhibitor therapy. Ann Oncol. 2013 Aug;24(8):2011-6. PMID: 23613476. PMCID: PMC3718506.

179. Hayes DF, Allen J, Compton C, Gustavsen G, Leonard DG, McCormack R, Newcomer L, Pothier K, Ransohoff D, Schilsky RL, Sigal E, Taube SE, Tunis SR. Breaking a vicious cycle. [Tumor-biomarker Diagnostics] Sci Transl Med. 2013 Jul 31;5(196):196cm6. PMID: 23903752.

180. Berman MG, Askren MK, Sook Jung M, Therrien B, Peltier S, Noll DC, Zhang M, Ossher L, Hayes DF, Reuter-Lorenz PA, Cimprich B. Pretreatment worry and neurocognitive responses in women with breast cancer. Health Psychol. 2014 Mar;33(3):222-31. PMID: 23914817.

181. Rae JM, Regan MM, Thibert JN, Gersch C, Thomas D, Leyland-Jones B, Viale G, Pusztai L, Hayes DF, Skaar T, Van Poznak C. Concordance between CYP2D6 genotypes obtained from tumor-derived and germline DNA. J Natl Cancer Inst. 2013 Sept 4;105(17):1332-1334. PMID: 23958736. PMCID: PMC3888280.

182. Yao S, Sucheston LE, Zhao H, Barlow WE, Zirpoli G, Liu S, Moore HC, Thomas Budd G, Hershman DL, Davis W, Ciupak GL, Stewart JA, Issacs C, Hobday TJ, Salim M, Hortobagyi GN, Gralow JR, Livingston RB, Albain KS, Hayes DF, Ambrosone CB. Germline genetic variants in ABCB1, ABCC1 and ALDH1A1, and risk of hematological and gastrointestinal toxicities in a SWOG Phase III trial S0221 for breast cancer. Pharmacogenomics J. 2013 Sep 3. [Epub ahead of print]. PMID: 23999597. PMCID: PMC3940691.

183. Wolff AC, Hammond ME, Hicks DG, Dowsett M, McShane LM, Allison KH, Allred DC, Bartlett JM, Bilous M, Fitzgibbons P, Hanna W, Jenkins RB, Mangu PB, Paik S, Perez EA, Press MF, Spears PA, Vance GH, Viale G, Hayes DF. Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update. J Clin Oncol. 2013 Nov 1;31(31):3997-4013. PMID: 24101045.

[Published simultaneously in Arch Pathol Lab Med. 2013 Oct 7. Epub ahead of print. PMID: 24099077.]

184. Yoon HJ, Kim TH, Zhang Z, Azizi E, Pham TM, Paoletti C, Lin J, Ramnath N, Wicha MS, Hayes DF, Simeone DM, Nagrath S. Sensitive capture of circulating tumour cells by functionalized grapheme oxide nanosheets. Nat Nanotechnol. 2013 Oct;8(10):735-41. PMID: 24077027.

185. Theriault RL, Carlson RW, Allred C, Anderson BO, Burstein HJ, Edge SB, Farrar WB, Forero A, Giordano SH, Goldstein LJ, Gradishar WJ, Hayes DF, Hudis CA, Isakoff SJ, Ljung BM, Mankoff DA, Marcom PK, Mayer IA, McCormick B, Pierce LJ, Reed EC, Schwartzberg LS, Smith ML, Soliman H, Somlo G, Ward JH, Wolff AC, Zellars R, Shead DA, Kumar R. Breast cancer, version 3.2013: featured updates to the NCCN guidelines. J Natl Compr Canc Netw. 2013 Jul;11(7):753-60; quiz 761. PMID: 23847214.

186. Henry NL, Chan HP, Dantzer J, Goswami CP, Li L, Skaar TC, Rae JM, Desta Z, Khouri N, Pinsky R, Oesterreich S, Zhou C, Hadjiiski L, Philips S, Robarge J, Nguyen AT, Storniolo AM, Flockhart DA, Hayes DF, Helvie MA, Stearns V. Aromatase inhibitor-induced modulation of breast density: clinical and genetic effects. Br J Cancer. 2013 Oct 29;109(9):2331-9. PMID: 24084768. PMCID: PMC3817329.

187. Robinson DR, Wu YM, Vats P, Su F, Lonigro RJ, Cao X, Kalyana-Sundaram S, Wang R, Ning Y, Hodges L, Gursky A, Siddiqui J, Tomlins SA, Roychowdhury S, Pienta KJ, Kim SY, Roberts JS, Rae JM, Van Poznak CH, Hayes DF, Chugh R, Kunju LP, Talpaz M, Schott AF, Chinnaiyan AM. Activating ESR1 mutations in hormone-resistant metastatic breast cancer. Nat Genet. 2013 Dec;45(12):1446-51. PMID: 24185510. PMCID: PMC4009946.

188. Polley MY, Leung SC, McShane LM, Gao D, Hugh JC, Mastropasqua MG, Viale G, Zabaglo LA, Penault-Llorca F, Bartlett JM, Gown AM, Symmans WF, Piper T, Mehl E, Enos RA, Hayes DF, Dowsett M, Nielsen TO; International Ki67 in Breast Cancer Working Group of the Breast International Group and North American Breast Cancer Group. An international Ki67 reproducibility study. J Natl Cancer Inst. 2013 Dec 18;105(24):1897-906. PMID: 24203987. PMCID: PMC3888090.

189. Henry NL, Xia R, Schott AF, McConnell D, Banerjee M, Hayes DF. Prediction of postchemotherapy ovarian function using markers of ovarian reserve. Oncologist 2014 Jan; 19(1):68-74. PMID: 24319018. PMCID: PMC3903057.

190. Henry NL, Conlon A, Kidwell KM, Griffith K, Smerage JB, Schott AF, Hayes DF, Williams DA, Clauw DJ, Harte SE. Effect of estrogen depletion on pain sensitivity in aromatase inhibitor-treated women with early-stage breast cancer. J Pain. 2014 May; 15(5):468-75. PMID: 24462504. PMCID: PMC4063362.

191. Henry LN, Hayes DF, Ramsey SD, Hortobagyi GN, Barlow WE, Gralow JR. Promoting quality and evidence-based care in early-stage breast cancer follow-up. J Natl Cancer Inst. 2014 Apr 1;106(4). PMID: 24627271. (No Federal support cited.). Erratum in J Natl Cancer Inst. 2014 May;106(5):dju126. Henry, Lynn N [corrected to Henry, N Lynn].

192. Kidwell KM, Harte SE, Hayes DF, Storniolo AM, Carpenter J, Flockhart DA, Stearns V, Clauw DJ, Williams DA, Henry NL. Patient-reported symptoms and discontinuation of adjuvant aromatase inhibitor therapy, Cancer. 2014 Aug 15;120(16):2403-11. PMID: 24802413. PMCID: PMC4126845.

193. Smerage JB, Barlow WE, Hortobagyi GN, Winer EP, Leyland-Jones B, Srkalovic G, Tejwani S, Schott AF, O’Rourke MA, Lew DL, Doyle GV, Gralow JR, Livingston RB, Hayes, DF. Circulating tumor cells and response to chemotherapy in metastatic breast cancer: SWOG S0500. J Clin Oncol. 2014 Nov 1;32(31):3483-9. PMID: 24888818. PMCID: PMC4209100.

194. Askren MK, Jung M, Berman MG, Zhang M, Therrien B, Peltier S, Ossher L, Hayes DF, Reuter-Lorenz PA, Cimprich B. Neuromarkers of fatigue and cognitive complaints following chemotherapy for breast cancer: a prospective fMRI investigation. Breast Cancer Res Treat. 2014 Sep; 147(2):445-55. PMID: 25138546. P MCID: PMC4165557.

195. Paoletti C, Muniz MC, Thomas DG, Griffith KA, Kidwell KM, Tokudome N, Brown M, Aung K, Miller MC, Blossom DL, Schott AF, Henry NL, Rae JM, Connelly MC, Chianese DA, Hayes DF. Development of circulating tumor cell-endocrine therapy index in patients with hormone receptor positive breast cancer. Clin Cancer Res. 2014 Nov 7. [Epub ahead of print]. PMID: 25381338. (No Federal support cited.)

196. Polley M-YC, BIG-NABCG Ki67 Working Group, et al. An international study to increase concordance in Ki67 scoring. Modern Pathol. In press.

Non Peer-Reviewed Publications:

Proceedings of Meetings:

1. Gurd RS, England RD, Hayes DF, Wittbort RH and Rothgeb TM. Formation and physiological role of carbamino adducts of angiotensin, bradykinin, and S-methylglucagon. Regensberg Symposium on Biophysics and Physiology of CO2. Biophysics and physiology of carbon dioxide, Bauer C, Gros G and Bartels H, eds. Berlin. 1980; 106–113.

2. Hayes DF, Tondini C, Abe M, Henderson IC and Kufe D. CA15-3 and related antigens: Sensitive and reliable markers for monitoring breast cancer. I1 carcinoma della mammella oggi: biologia e approccio clinico, eds. Milan. 1988; 129–136.

3. Abe M, Siddiqui J, Hayes DF and Kufe DW. Isolation and sequencing of a cDNA coding for human DF3 breast carcinoma-associated antigen. Human tumor antigens and specific tumor therapy, Metzgar R and Mitchell M, eds. New York. 1988.

4. Hayes DF and Henderson IC. Endocrine therapy for metastatic breast cancer: Sequential and combination endocrine treatments. In: Meerpohl H, Kaufmann M, Alt D and Pfleiderer A , eds. Antiostrogene in Forschung und Klinik. Munich: Verlag GmbH. 1989; 129–137.

5. Hayes DF, Abe M, Siddiqui J, Tondini C and Kufe DW. Clinical and molecular investigations of the DF3 breast cancer-associated antigen. Immunological approaches to the diagnosis and therapy of breast cancer II, Ceriani RL, eds. New York. 1989; 45–53.

6. Hayes DF, Tondini C and Kufe DW. CA15-3. Updating on tumor markers in tissue and in biological fluids: Basic aspects and clinical applications, Ballesta A, Torre GC, Bombardieri E, Gion M and Mollina R, eds. Torino, Italy. 1993; 525–535.

7. Hayes DF. Serum tumor markers for breast cancer. Proceedings; 5th Annual Conference, Adjuvant Therapy in Primary Breast Cancer. In: Senn HJ, Gelber RD, Goldhirsch A, Thurlimann B, eds. Recent Results of Cancer Research. Heidelberg: Springer-Verlag. 1996; 101–114.

8. Hayes DF. Determination of clinical utility of tumor markers: A tumor marker utility gradingsystem. Proceedings: 6th Annual Conference, Adjuvant Therapy in Primary Breast Cancer. In: Senn HJ, Gelber RD, Goldhirsch A, Thurlimann B, eds. Recent Results of Cancer Research. Heidelberg: Springer-Verlag. 1998; 71–85.

9. Graves R, Hilgers J, Fritsche H, Hayes DF, and Robertson JFR. MUCI mucin assays for monitoring therapy in metastatic breast cancer. The Breast. 1998; 181: 64–67.

10. Schwartz, GF, Giuliano, AE, Veronesi U and the Consensus Conference Committee. Proceedings of the Consensus Conference on the Role of Sentinel Lymph Node Biopsy in Carcinoma of the Breast, April 19–22, 2001, Philadelphia, Pennsylvania. Cancer. 2002; 94: 2542–2551.

11. Hayes DF. Markers of Increased Risk for Failure of Adjuvant Therapies. Proceedings of Primary Therapy of Early Breast Cancer, 8th Annual International Conference, St. Gallen Switzerland. 2003; March: 12–15.

12. Schwartz GF, Hortobagyi GN, and the Consensus Conference Committee. Proceedings of the Consensus Conference on Neoadjuvant Chemotherapy in Carcinoma of the Breast. Philadelphia, Pennsylvania. 2003; April: 26–28.

13. Hayes DF. Prognostic and predictive factors revisited. Proceedings of Primary Therapy of Early Breast Cancer, 9th International Conference, St. Gallen Switzerland. 2005; January: 26–29.

14. Soper SA, Brown, K, Ellington, A, Frazier B, Guillermo Garcia-Manero, Gau V, Guttman S., Hayes DF, Korte B., Landers J., Larson D., Ligler F., Majumdar A., Mascini M., Nolte D., Rosenzweig Z, Wang J., Wilson D. Point-of-care biosensor systems for cancer diagnostics/prognostics. Biosensors and Bioelectronics. 2006; 21: 1932–1942.

15. Ambrosone CB, Rebbeck TR, Morgan GJ, Albain KS, Calle EE, Evans WE, Hayes DF, Kushi LH, McLeod HL, Rowland JH, Ulrich CM. New developments in the epidemiology of cancer prognosis: traditional and molecular predictors of treatment response and survival. Cancer Epidemiol Biomarkers Prev. 2006; 15: 2042–2046.

16. Hayes DF, Miller K, Sledge G. Angiogenesis as targeted breast cancer therapy. The Breast. 2007 Dec;16 Suppl 2:S17–S19. Epub 2007 Aug 17. PMID: 17707641.

17. Hayes DF. Markers of endocrine sensitivity. Breast Cancer Res. 2008;10 Suppl 4:S18. PMID: 19128431.

18. Hayes DF. Is there a standard type and duration of adjuvant chemotherapy for early stage breast cancer? Breast. 2009 Oct;18 Suppl 3:S131–4. Proceedings of Primary Therapy of Early Breast Cancer, 11th International Conference, St. Gallen Switzerland. 2009; March 11–14. PMID: 19914531.

19. Hayes DF. Disease related indicators for a proper choice of adjuvant treatments. The Breast. 2011 Oct; v. 20, Suppl 3:S162-4. Proceedings of the 12th International Conference on Primary Therapy of Early Breast Cancer. PMID: 22015287.

20. Goldhirsch A, Winer EP, Coates AS, Gelber RD, Piccart-Gebhart M, Thürlimann B, Senn HJ; Panel Members. Collaborators (51). Personalizing the treatment of women with early breast cancer: highlights of the St. Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2013. Ann Oncol. 2013 Sept;24(9):2206-23. PMID: 23917950.

Non Peer-Reviewed Publications:

Reviews, Editorials, Chapters, and Educationally Relevant Publications:

1. Hayes DF. Is there a role for pulmonary nodulectomy in urologic cancers? In: Garnick M, eds. Genitourinary Cancer. New York: Churchill Livingstone, 1985; 243–272.

2. Henderson IC, Hayes DF, and Gelman R. Dose response in the treatment of breast cancer: A critical review. J Clin Oncol. 1986; 6:1501–1515.

3. Henderson IC, Hayes DF, Come S, Harris JR and Canellos G. New agents and new medical treatments for advanced breast cancer. Semin Oncol. 1987; 14:34–64.

4. Hayes DF and Henderson IC. CAF in metastatic breast cancer: Standard therapy or another effective regimen. J Clin Oncol. 1987; 5:1497–1499.

5. Kufe D, Hayes DF, Abe M, Ohno T, Lundy J, and Schlom J. Monoclonal antibody assays for breast cancer. In: Kupchick H , eds. In vitro diagnosis of human tumors using monoclonal antibodies. New York: Marcel-Dekker, 1988; 67–100.

6. Hayes DF, Friedman EL, and Kufe DW. Radioimmunoscintigraphy of human carcinoma: characterization of monoclonal antibodies. In: Zalutsky MR , eds. Antibodies in radiodiagnosis and therapy. Boca Raton, FL: CRC Press, 1988.

7. Kufe D, Hayes DF, Abe M, and Ohno T. CA15-3 and related antigens as serum markers for monitoring breast cancer. In: Rich MA, Hager JC and Lopez DM , eds. Breast Cancer. Academic Publishers, 1988; 202–273.

8. Henderson IC, Hayes DF, Rose MA, Come S, and Harris JR. The integration of radiotherapy and chemotherapy in the treatment of early breast cancer. In: Kubli F, von Fournier D, Jungerman H, Bauer M and Kaufman M , eds. Breast diseases: breast conserving therapy, non invasive lesions, mastopathy. Berlin: Springer Verlag, 1989; 416–435.

9. Tondini C, Hayes DF, and Kufe D. Circulating tumor markers in breast cancer. In: Henderson IC, eds. Diagnosis and therapy of breast cancer. Philadelphia: W.B. Saunders Co., 1989; 653–674.

10. Henderson IC, Hayes DF, and Gelman R. Letter to Editor. J Clin Oncol. 1989; 7:682–683.

11. Hayes DF and Henderson IC. Endocrine therapy for metastatic breast cancer: Sequential and combination endocrine treatments. In: Meerpohl H, Kaufmann M, Alt D and Pfleiderer Al, eds. Antiostrogene in Forschung und Klinik. Munich: Verlag GmbH, 1989; 129–147.

12. Hayes DF and Henderson IC. Adjuvant therapy for node-negative breast cancer patients. Adv Oncol. 1990; 6:8–18.

13. Henderson IC, Garber JE, Breitmeyer JB, Hayes DF, and Harris JR. Comprehensive management of disseminated breast cancer. Cancer. 1990; 66:1439–1448.

14. Henderson IC, Hayes DF, Parker L, Love S, Garber J, Recht A, Breitmeyer J, Harris J, and Canellos G. Adjuvant systemic therapy for patients with node-negative tumors. Cancer. 1990; 65:2132–2147.

15. Hayes DF. Axillary lymphoscintigraphy for breast cancer: Should we do it? Can we do it? J Nucl Med. 1990; 31:1835–1838.

16. Hayes DF and Henderson IC. Adjuvant therapy of cancer. In: Moosa A, Schimpff S and Robson M, eds. Comprehensive Textbook of Oncology. Baltimore: Williams & Wilkins, 1991; 569–578.

17. Hayes DF and Kaplan W. Evaluation of patients following primary therapy. In: Harris J, Hellman S, Henderson I and Kinne D , eds. Breast Diseases. Philadelphia: J. B. Lippincott, 1991; 505–525.

18. Recht A and Hayes DF. Specific sites and emergencies: Local recurrence. In: Harris JR, Hellman S, Henderson IC and Kinne DW , eds. Breast Diseases, 2nd Edition. Philadelphia: J.B. Lippincott Co., 1991; 527–540.

19. Hayes D. What would you do if this were your... wife, sister, mother, self? J Clin Oncol. 1991; 9:1–3.

20. Boyd FJ, McKenney SA, Hayes DF, Bushnell SS, Card IC, Quadrino A, and Griesemer S. Psychosocial issues in breast reconstruction. Cancer. 1991; 68:1176–1177.

21. McKenna RJ, Sr., Greene T, Hang-Fu LC, Hayes DF, Scanlon EF, Schweitzer RJ, Strax P, Winchester DP, and Wood WC. Implications for clinical management in patients with breast cancer. Long-term effects of reconstruction surgery. Cancer. 1991; 68:1182–3.

22. Hayes DF, Tondini C and Kufe DW. Clinical applications of CA15-3. In: Sell S , eds. Serological Cancer Markers. Totowa, New Jersey: The Humana Press, Inc., 1992; 281–307.

23. Recht A, Hayes DF, and Harris JR. The use of adjuvant therapy in patients treated with conservative surgery and radiotherapy. In: Henderson IC , eds. Adjuvant Therapy of Breast Cancer. Norwell, MA: Kluwer Academic Publishers, 1992; 223–237.

24. Hayes DF and Henderson IC. Breast Cancer. In: Horwich A , eds. Combined Radiotherapy and Chemotherapy in Clinical Oncology. London: Edward Arnold, 1992; 183–196.

25. Hayes DF. Fine-needle aspiration and flow cytometry for evaluation of primary breast cancer. Radiology. 1992; 185:337–338.

26. Shapiro CL and Hayes DF. Breast cancer screening and prevention. Contemp Intern Med. 1993; 5:60–9.

27. Shapiro CL and Hayes DF. Current recommendations on breast cancer treatment. Contemp Intern Med. 1993; 5:35–40, 44–5.

28. Hayes DF. We may be lost, but we’re sure makin’ good time. (Editorial). Cancer Invest. 1993; 11:88–90.

29. Hayes DF. Introduction to breast cancer. In: Hayes DF , eds. Atlas of Breast Cancer. London: Mosby Europe Limited, 1993; Ch. 1.

30. Hayes DF. Risk factors, epidemiology, and development of breast cancer. In: Hayes DF, eds. Atlas of Breast Cancer. London: Mosby Europe Limited, 1993; Ch. 2.

31. Hayes DF. Principles of systemic therapy. In: Hayes DF , eds. Atlas of Breast Cancer. London: Mosby Europe Limited, 1993; Ch. 10.

32. Hayes DF. Adjuvant systemic therapy. In: Hayes DF , eds. Atlas of Breast Cancer. London: Mosby Europe Limited, 1993; Ch. 11.

33. Hayes DF. Locally advanced, locally recurrent, and metastatic breast cancer. In: Hayes DF, eds. Atlas of Breast Cancer. London: Mosby Europe Limited, 1993; Ch. 12.

34. Hayes DF. Tumor markers for breast cancer. Ann Oncol. 1993; 4:807–819.

35. Hayes DF. Angiogenesis and Breast Cancer. In: Shapiro CL and Henderson IC , eds. Hematology/Oncology Clinics of North America. Philadelphia: W.B. Saunders Co., 1994; 51–71.

36. Hayes DF. Medical oncologists and risk management in breast cancer. In: Kern KA and Cady B, eds. Surgical Oncology Clinics of North America. Medicolegal Controversies in Breast Cancer: Biologic Basis and Risk Prevention. Philadelphia: J.B. Lippincott Co., 1994; 149–172.

37. Hayes DF. What are tumor markers, and when should they be used? In: American Society of Clinical Oncology , eds. Educational Book: 30th Annual Meeting. Dallas: American Society of Clinical Oncology, 1994; 138–149.

38. Hayes DF. Preface. In: Hayes DF , eds. Hematology/Oncology Clinics of North America: Tumor Markers in Adult Solid Malignancies. Philadelphia:W.B.Saunders Co., 1994; ix–x.

39. Hayes DF. Tumor Markers for Breast Cancer: Current Utilities and Future Prospects. In: Hayes DF, eds. Hematology/Oncology Clinics of North America: Tumor Markers in Adult Solid Malignancies. Philadelphia: W.B. Saunders Co., 1994; 485–506.

40. Hayes DF, Henderson IC, and Shapiro CL. Treatment of metastatic breast cancer: Present and future prospects. Semin Oncol. 1995; 22:5–21

41. Legler CM, Shapiro CL, Harris JR, and Hayes DF. Primary chemotherapy of resectable breast cancer. Breast J. 1995; 1:42–51.

42. Hayes DF and Kaplan W. Evaluation of patients following primary therapy. In: Harris J, Hellman S, Lippman M and Morrow M , eds. Diseases of the Breast. Philadelphia: J. B. Lippincott, 1996; 629–647.

43. Recht A, Hayes DF, Eberlein TJ, and Sadowsky NL. Local-regional recurrence after mastectomy or breast conserving therapy. In: Harris J, Hellman S, Lippman M and Morrow M, eds. Diseases of the Breast. Philadelphia: J. B. Lippincott, 1996; 649–667.

44. Legler CM and Hayes DF. Doxorubicin for inflammatory breast cancer: A red humor for a red tumor. Ann Surg Oncol. 1995; 2:283–285.

45. Hayes DF and Harris J. Local therapy for breast cancer: cure or upfront palliation. Oncology 1996; 10:1007–1011 (comment).

46. Hayes DF. Should we treat HER, too? J Clin Oncol. 1996; 14:697–699.

47. Hayes DF. Tumor markers. In: Kelley WN , eds. Textbook of Internal Medicine, Third Edition. Philadelphia: J.B. Lippincott, 1997; 1488–1491.

48. Fertig D and Hayes DF. The psychological consequences of tumor marker use in breast cancer. In: Holland J, Breitbart W, Lederberg M. Loscalzo M, Massie MJ, McCorkle R, eds. Textbook of Psycho-oncology. Oxford, Oxford University Press. New York Oxford. 1998; 147–160.

49. Ellis MJC and Hayes DF. Improving hormonal therapy for breast cancer. Breast J. 1997; 3 (suppl):57–68.

50. Hayes DF. Ductal carcinoma in situ of the breast: a new model. J. Natl Cancer Inst. 1997; 89:991–993.

51. Esteva-Lorenzo FJ and Hayes DF. Monoclonal antibody-based therapy of breast cancer. In: Grossbard M, ed. Monoclonal Antibody-based Therapy of Cancer. New York, Marcel Dekker, Inc. 1998; 309–338.

52. Hayes DF. Expert consultations in breast cancer: critical pathways and clinical decision making, Ed. Hait W. August D, Haffty B, Marcel Dekker New York, Basel, 1999.

53. Hayes DF, Trock B, and Harris A. Assessing the impact of prognostic factors: When is “statistically significant” clinically useful? Breast Cancer Res Treat. 1998; 52:305–319.

54. Stearns V, Yamauchi H, and Hayes, DF. Circulating tumor markers in breast cancer: accepted utilities and novel prospects. Breast Cancer Res Treat. 1998; 52:239–254.

55. Hayes DF. Determination of clinical utility of tumor markers: a tumor marker utility grading system. Recent Results Cancer Res. 1998; 152:71–85.

56. Stearns V and Hayes DF. Biologic crrelates of breast cancer. Adv Oncol. 1999; 15:15–22.

57. Rizvi N and Hayes DF. A “breathalyser” for lung cancer? Lancet. 1999; 353:1897–1898.

58. Hayes DF, Ellis MJ, and Isaacs CI. Déjà vu all over again? Oncology. 1999; 13:1141.

59. Siziopikou K, Schnitt S, Connolly J, and Hayes DF. Detection and significance of occult axillary metastatic disease in breast cancer patients. Breast J. 1999; 5:221–229.

60. Ellis M and Hayes DF. Refining breast cancer risk assessment with molecular markers; the next step? J Natl Cancer Inst. 1999; 91:2067–2068.

61. Hayes DF, Ellis MJ, and Isaacs C. The Marks, Hardenbergh, Prosnitz article reviewed: mounting evidence for postmastectomy radiation therapy. Oncology. 1999; 13:1141.

62. Hayes DF. Tumor markers. In: Kelley WN, eds. Textbook of Internal Medicine, Fourth Edition. Philadelphia: J.B. Lippincott. 2000; 1811–1815.

63. Ellis M, Hayes DF, and Lippman ME. Treatment of Metastatic Disease. In: Harris J, Lippman M, Morrow M and Osborne CK, eds. Diseases of the Breast. Philadelphia: Lippincott-Raven, 2000; 749–798.

64. Hayes DF. Evaluation of patients following primary therapy. In: Harris J, Lippman M, Morrow M and Osborne CK, eds. Diseases of the Breast. Philadelphia: Lippincott-Raven, 2000; 709–730.

65. Hayes DF. Clinical importance of prognostic factors: moving from scientifically interesting to clinical useful. In: Bronchud M., Robinson M., Petes W., Molecular Manual of Cancer. Totowa, NJ: Humana Press, 2000; pp. 29–44.

66. Hayes DF. Do we need prognostic factors in nodal-negative breast cancer? Eur J Cancer, 2000; 36:302–306

67. Fitzgibbons PL, Page DL, Weaver D, Thor AD, Allred DC, Clark GM, Ruby SG, O’Malley F, Simpson JF, Connolly JL, Hayes DF, Edge SB, Lichter A, and Schnitt SJ. Prognostic factors in breast cancer. Arch Pathol Lab Med 2000; 124:966–978.

68. Hayes DF. Designing tumor marker studies: will the results provide clinically useful information? Arch Pathol Lab Med 2000; 124:952–954.

69. Stearns V, Hayes DF. Commentary on “A study of the value of p53, HER2, and Bcl-2 in the prediction of response to doxorubicin and paclitaxel as single agents in metastatic breast cancer: a companion study to EORTC 10923.” Clin Breast Cancer 2000; 1:20–21.

70. Hayes DF, Yamauchi H, Stearns V, Brotzman M, Isaacs C, Trock B. Should all breast cancers be tested for c-erb-2? Education Book: Am Soc Clin Oncol. 2000; 257–265.

71. Loprinzi CL, Hayes DF, and Smith T. Doc, shouldn't we be getting some tests? J Clin Oncol. 2000; 18:2345

72. Hayes DF. Commentary on “Dose Intensities for Breast Cancer.” Oncology. 2001; 15:701–718.

73. Lippman ME and Hayes DF. Adjuvant therapy for all patients with breast cancer? J Natl Cancer Inst. 2001; 93:80.

74. Yamauchi H, Stearns V, and Hayes DF. The role of c-erbB-2 as a predictive factor in breast cancer. Breast Cancer: J Japanese Breast Cancer Soc. 2001; 8:3171–3183.

75. Isaacs, C., Stearns V, and Hayes DF. New prognostic factors for breast cancer recurrence. Semin Oncol. 2001; 128:53

76. Hayes DF. Why endocrine therapy? In: Miller WR, Ingle JN, eds: Endocrine Therapy in Breast Cancer, 1st Edition, 2002; 3–16.

77. Stearns V and Hayes DF. Clinical evaluation criteria for tumor markers. In: Tumor Markers: Physiology, Pathobiology, Technology and Clinical Applications. Diamandis, Fritsche, Lilja, Chan, and Schwartz, Eds. AACC Press. 2002.

78. Stearns V and Hayes DF. Cooling Off Hot Flashes. J Clin Oncol. 2002; 6:1436–138.

79. Stearns V and Hayes DF. Approach to menopausal symptoms in women with breast cancer. Curr Treat Options Oncol. 2002; 3:179–190.

80. Hayes DF. Is there a role for monitoring circulating HER2? Clin Breast Cancer. 2002; 3:136–137.

81. Hayes DF, Isaacs C, and Stearns V. Prognostic factors in breast cancer: current and new predictors of metastasis. J Mammary Gland Biol Neoplasia. 2002; 6:375–392.

82. Hayes DF and Thor A. C-erbB-2 in breast cancer: development of a clinically useful marker. Semin Oncol. 2002; 29:231–245.

83. Singletary SE, Allred C, Ashley P, Bassett LW, Berry D, Bland KI, Borgen PI, Clark G, Edge SB, Hayes DF, Hughes LL, Hutter RV, Morrow M, Page DL, Recht A, Theriault RL, Thor A, Weaver DL, Wieand HS, and Greene FL. Revision of the American Joint Committee on Cancer staging system for breast cancer. J Clin Oncol. 2002; 20:3628–3636.

84. Truica C and Hayes DF. Early Operable Breast Cancer: Systemic Management. In: International Handbook of Breast Cancer. S. Johnston, ed. Euromed Communications, Ltd., Surrey, England. 1st Edition, 2002; 87–103.

85. Hayes DF and Robertson JF. Overview and Concepts of Endocrine Therapy. In: Use of Endocrine Therapies in Clinical Practice. Martin Dunitz Ltd. Publishers. 1st Edition, 2002; 3–10.

86. Hayes DF. Forward. Case Presentations in the Endocrine Management of Breast Cancer. Nova Professional Media Limited. 2002.

87. Sabel M and Hayes DF. Cyclin E and breast cancer prognosis: an early victory but a long season ahead. Am J Oncol Rev. 2003; 2:17–20.

88. Singletary SE, Allred C, Ashley P, Bassett LW, Berry D, Gland KI, Borgen PI, Clark GM, Edge SB, Hayes DF, Hughes LL, Hutter RVP, Morrow M, Page DL, Recht A, Theriault RL, Thor A, Weaver D, Wieand HS, and Greene FL. Staging System for Breast Cancer: Revisions for the 6th Edition of the AJCC Cancer Staging Manual. Surgical Clinics of North America. 2003; 83:803–819.

89. Hayes DF. Clinical Importance of Prognostic Factors: Moving from Scientifically Interesting to Clinically Useful. In: Principles of Molecular Oncology. Bronchud MH, Foote MA, Giaccone G, Olopade O, and Workman P, eds. Humana Press Inc., Totowa, NJ. 2nd Edition, 2003; 51–72.

90. Hayes DF. Playing the old piano: another tune for endocrine therapy? J Natl Cancer Inst. 2003; 95.

91. Hayes DF. Markers of increased risk for failure of adjuvant therapies. The Breast. 2003; 12:543.

92. Schott A and Hayes DF. Adjuvant chemotherapy for elderly women with hormone receptor-positive breast cancer: an old(er) problem. J Clin Oncol. 2004; 22:4660–4662.

93. Hayes DF. Tamoxifen: Dr. Jekyll and Mr. Hyde? J Natl Cancer Inst. 2004; 96:95–897.

94. van’t Veer LJ, Paik S, Hayes DF. Gene expression profiling of breast cancer: a new tumor marker. J Clin Oncol. 2005; 23:1631–1635.

95. Hayes DF. Prognostic and predictive factors for breast cancer: translating technology to oncology. J Clin Oncol. 2005; 23:596–1597.0

96. Rae JM, Goetz MP, Hayes DF, Ingle JN, Li L, Storniolo AM, Stearns V, and Flockhart DA. CYP2D6 genotype and tamoxifen response. Breast Cancer Res. 2005; 7:E6.

97. Carlson RE, Anderson BO, Burstein HJ, Cox CE, Edge SB, Farrar WB, Goldstein LJ, Gradishar WJ, Hayes DF, Hudis C, Jahanzeb M, Ljung BM, Marks LB, McCormick B, Nabell LM, Pierce LJ, Reed EC, Silver SM, Smith ML, Somlo G, Theriault RL, Ward JH, Winer EP, Wolff AC; National Comprehensive Cancer Network. Breast Cancer. J Natl Compr Canc Netw. 2005 May;3(3):238–289. PMID: 16002000.

98. Smerage JB, and Hayes DF The measurement and therapeutic implications of circulating tumour cells in breast cancer. Br J Cancer. 2006 Jan 16; 94(1):8–12.PMID: 16317435.

99. Hayes DF. Breast Cancer. In: Prognostic Factors in Cancer. M.K. Gospodarowicz, B. O’Sullivan, and L.H. Sobin, ed. International Union Against Cancer, John Wiley and Sons, Inc., Hoboken, NJ. 3rd Edition, 2006; 207–212.

100. Hayes DF and Picard MH. Heart of darkness: the downside of trastuzumab. J Clin Oncol. 2006 Sept 1; 24(25):4056–4058. Epub 2006 Aug 14. PMID: 16908930.

101. Henry NL, Diehl KM, and Hayes DF. Adjuvant systemic therapy for elderly women with breast cancer. Women’s Health. 2006; 2:75–87.

102. Hayes DF, Ethier S, and Lippman ME. New guidelines for reporting of tumor marker studies in brest cancer research and treatment: REMARK. Breast Cancer Res Treat. 2006 Nov; 100(2):237–238. Epub 2006 Jun 14. PMID: 16773436.

103. Muller V, Hayes DF, Pantel K. Recent translational research: circulating tumor cells in breast cancer patients. Breast Cancer Res. 2006; 8(5):110. Review. PMID: 16953898.

104. Stearns V, Schneider B, Henry NL, Hayes DF, Flockhart DA. Breast cancer treatment and ovarian failure: risk factors and emerging genetic determinants. Nat Rev Cancer. 2006 Nov; 6(11):886–893. Review. PMID: 17036039.

105. Van Poznak CH and Hayes DF. Aromatase inhibitors for the treatment of breast cancer: Is tamoxifen of historical interest only? J Natl Cancer Inst. 2006 Sep 20; 98(18):1261–1263. PMID: 16985239.

106. Henry NL and Hayes DF. Uses and abuses of tumor markers in the diagnosis, monitoring and treatment of primary and metastatic breast cancer. Oncologist. 2006 Jun; 11(6):541–552. Review. PMID: 16794234.

107. Smerage JB, Hayes DF. The prognostic implications of circulating tumor cells in patients with breast cancer. In: Breast Cancer: Translational Therapeutic Strategies; Section II: Molecular and Cellular Markers of Prognosis. Eds. Gary H. Lyman and Harold J. Burstein. Informa Healthcare (Taylor & Francis Group), London. ISBN: 9780849374166. Publication date: 01/19/2007, pp. 69–77.

108. Giacomini KM, Brett CM, Altman RB, Benowitz NL, Dolan ME, Flockhart DA, Johnson JA, Hayes DF, Klein T, Krauss RM, Kroetz DL, McLeod HL, Nguyen AT, Ratain MJ, Relling MV, Reus V, Roden DM, Schaefer CA, Shuldiner AR, Skaar T, Tantisira K, Tyndale RF, Wang L, Weinshilboum RM, Weiss ST, Zineh I. Pharmacogenetics Research Network. The pharmacogenetics research network: from SNP discovery to clinical drug response. Clin Pharmacol Ther. 2007 Mar; 81(3):328–345. Review. PMID: 17339863.

109. Hayes DF. Quantitative measures of oestrogen receptor and ERBB2 expression.

Lancet Oncol. 2007 Mar;8(3):184–185. PMID: 17329185.

110. Carlson RW, Anderson BO, Burstein HJ, Carter WB, Edge SB, Farrar WB, Goldstein LJ, Gradishar WJ, Hayes DF, Hudis CA, Jahanzeb M, Ljung BM, Kiel K, Marks LB, McCormick B, Nabell LM, Pierce LJ, Reed EC, Silver SM, Smith ML, Somlo G, Theriault RL, Ward JH, Winer EP, Wolff AC. Invasive breast cancer. J Natl Compr Canc Netw, 2007 Mar; 5(3):246–312. PMID: 17439758.

111. Henry NL, Hayes DF. Can biology trump anatomy? Do all node-positive patients with breast cancer need chemotherapy? J Clin Oncol. 2007; 25: 2501–2503. PMID: 17577024.

112. Hayes DF. Clinical practice. Follow-up of patients with early breast cancer. N Engl J Med. 2007; 356: 2505–2513. PMID: 17568031.

113. Wolff AC, Hammond MEH, Schwartz JN, Hayes DF, On Behalf of the ASCO/CAP Panel on HER-2 Testing in Breast Cancer. J Clin Oncol 2007; Sept 5, 4021–4023. Correspondence: Reply to letter from A. Raji.

114. Hayes DF. Book Review: False hope: Bone marrow transplantation for breast cancer by Rettig RA, Jacobson PD, Farquhar CM, and Aubry WM. New Engl J Med 2007: Sept 6; 357:1059–1060.

115. Hayes DF. Author response. Correspondence from Sakemi H, and Butsch WS, Munoz AJ, and Heimburger DC: Follow-up of patients with early breast cancer by Hayes DF. N Engl J Med 2007: Sept 6; 357:1053.

116. Sabel MS and Hayes DF. The Kahn article reviewed. [Areas of Confusion in Oncology: Does resection of an intact breast primary improve survival in metastatic breast cancer? Review by Khan SE, Oncology July 2007, Vol. 21, No. 8, pp. 924–931.] Oncology July

117. Henry NL, Hayes DF. Use of gene-expression profiling to recommend adjuvant chemotherapy for breast cancer. Oncology (Williston Park). 2007 Oct;21(11):1301–1309. PMID: 18080616.

118. Smerage JB and Hayes DF. The prognostic implications of circulating tumor cells in patients with breast cancer. Cancer Invest. 2008 Mar;26(2): 109–114. PMID: 18259939.

119. Sargent DJ, Hayes DF. Assessing the measure of a new drug: is survival the only thing that matters? J Clin Oncol. 2008 Apr 20;26(12):1922–1923. PMID: 18421044.

120. Hayes DF. Smerage J. Is there a role for circulating tumor cells in the management of breast cancer? Clin Cancer Res. 2008 Jun 15;14(12): 3646–3650. PMID: 18559576.

121. Hayes DF, Stearns V, Rae J, Flockhart D; Consortium on Breast Cancer Pharmacogenomics (COBRA). A model citizen? Is tamoxifen more effective than aromatase inhibitors if we pick the right patients? J Natl Cancer Inst. 2008 May 7;100(9): 610–613. Epub 2008 Apr 29. PMID: 18445818.

122. Henry NL, Stearns V, Flockhart DA, Hayes DF, Riba M. Drug interactions and pharmacogenomics in the treatment of breast cancer and depression. Am J Psychiatry. 2008 Oct;165(10):1251–1255. PMID: 18829880.

123. Higgins MJ, Rae JM, Flockhart DA, Hayes DF, Stearns V. Pharmacogenetics of tamoxifen: who should undergo CYP2D6 genetic testing? J Natl Compr Canc Netw. 2009 Feb;7(2):203–213. PMID: 19200418.

124. Hayes DF. Cyclin E as a prognostic factor: what is the question? Cell Cycle. 2009 Apr 1;8(7):965. PMID: 19305167.

125. Hayes DF, Cristofanilli M. Letter to the Editor – Re: Anti-epithelial cell adhesion molecule antibodies and the detection of circulating normal-like breast tumor cells. J Natl Cancer Inst. 2009 Jun 16;101(12):894–5; author reply 896–7. Epub 2009 Jun 9. No abstract available. PMID: 19509356.

126. Hammond EH, Wolff AC, Hayes DF, Schwartz JN. Letter to the Editor – Reply to G. Sauter et al. J Clin Oncol. 2009 Oct 20;27(30):e153–4;author reply e155–7. Epub 2009 Sep 8. PMID: 19738107.

127. Okunieff P, Kachnic LA, Constine LS, Fuller CD, Gaspar LE, Hayes DF, Hooks J, Ling C, Meyskens FL Jr, Philip PA, Raben D, Smalley SR, Swanson GP, Teicher BA, Thomas CR Jr, Vikram B, Zelefsky MJ, Baker LH. Report from the Radiation Therapy Committee of the Southwest Oncology Group (SWOG): Research Objectives Workshop 2008. Clin Cancer Res. 2009 Sep 15;15(18):5663–70. PMID: 19723641.

128. Henry NL, Hayes DF, Rae JM. CYP2D6 testing for breast cancer patients: is there more to the story? Oncology (Williston Park). 2009 Dec;23(14):1236, 1243, 1249. PMID: 20120836.

129. Hayes, DF. Contribution of biomarkers to personalized medicine. Breast Cancer Res. 2010 Dec 20; 12 Suppl 4:S3. PMID: 21172087. PMCID: PMC3005723.

130. Smerage JB, Hayes DF. Bone marrow micrometastases and circulating tumor cells. In Diseases of the Breast, Fourth Edition. Chapter 33. Pages 473–482, 2010. Philadelphia. Wolters Kluwer|Lippincott Williams & Wilkins. ISBN: 978-0-7817-9117-5.

131. Hayes DF, Smerage JB. Circulating Tumor Cells. In Progress in Molecular Biology and Translational Science. Chapter 5. Volume 95, Pages 95-112, 2010. Edited by: Raymond W. Ruddon. Elsevier Inc. ISBN: 978-0-12-385071-3.

132. Hayes DF. Bevacizumab treatment for solid tumors: boon or bust? JAMA. 2011 Feb 2:305(5):506-8. PMID: 21285431.

133. Wicha MS, Hayes DF. Circulating tumor cells: not all detected cells are bad and not all bad cells are detected. J Clin Oncol. 2011 Apr 20;29(12):1508-11. PMID: 21422428.

134. Hammond ME, Hayes DF, Wolff AC. Clinical notice for American Society of Clinical Oncology–College of American Pathologists Guideline Recommendations on ER/PgR and HER2 testing in breast cancer. J Clin Oncol. 2011 May 20;29(15):e458. PMID: 21502545.

135. Griggs JJ, Hayes DF. Do all patients with breast cancer require systemic adjuvant therapy? J Natl Cancer Inst. 2011 Sept 21;103(18):1350-1. PMID: 21881041.

136. Hayes DF. Steady progress against HER-2 positive breast cancer. N Engl J Med. 2011 Oct 6;365(14);1336-8. PMID: 21991956.

137. Hayes DF. Disease related indicators for a proper choice of adjuvant treatments. Breast. 2011 Oct;20 Suppl 3:S162-4. PMID: 22015287.

138. Febbo PG, Ladanyi M, Aldape KD, De Marzo AM, Hammond ME, Hayes DF, Iafrate AJ, Kelley RK, Marcucci G, Ogino S, Pao W, Sgroi DC, Birkeland ML. NCCN Task Force report: Evaluating the clinical utility of tumor markers in Oncology. J Natl Compr Canc Netw. 2011 Nov 1;9 Suppl 5:S1-32; quiz S33. PMID: 22138009.

139. Hayes DF. Clinical trials: The silent minority—unpublished data on cancer care. Nat Rev Clin Oncol. 2011 Nov;8, 631-632. PMID: 21971591.

140. Henry NL, Hayes DF. Cancer biomarkers. Mol Oncol. 2012 6:140-146. PMID: 22356776.

141. Hayes DF. Targeting adjuvant chemotherapy: A good idea that needs to be proven! J Clin Oncol. 2012 April 20;30(12):1264-7. PMID: 22355050.

142. Schott AF, Hayes DF. Defining the benefits of neoadjuvant chemotherapy for breast cancer. J Clin Oncol. 2012 May 20;30(15):1747-9. PMID: 22508810.

143. Carlson RW, Allred DC, Anderson BO, Burstein HJ, Edge SB, Farrar WB, Forero A, Giordano SH, Goldstein LJ, Gradishar WJ, Hayes DF, Hudis CA, Isakoff SJ, Ljung BM, Mankoff DA, Marcom PK, Mayer IA, McCormick B, Pierce LJ, Reed EC, Smith ML, Soliman H, Somlo G, Theriault RL, Ward JH, Wolff AC, Zellars R, Kumar R, Shead DA; National Comprehensive Cancer Network. Metastatic breast cancer, version 1.2012: featured updates to the NCCN guidelines. J. Natl Compr Canc Netw. 2012 Jul 1;10(7):821-9. PMID: 22773798.

144. Parkinson DR, Dracopoli N, Gumbs Petty B, Compton C, Cristofanilli M, Deisseroth A, Hayes DF, Kapke G, Kumar P, Lee JSh, Liu MC, McCormack R, Mikulski S, Nagahara L, Pantel K, Pearson-White S, Punnoose EA, Roadcap LT, Schade AE, Scher HI, Sigman CC, Kelloff GJ. Considerations in the development of circulating tumor cell technology for clinical use. J Transl Med. 2012 Jul 2;10:138. PMID: 22747748. PMCID: PMC3478228.

145. Wolff AC, Hammond ME, Hayes DF. Re: predictability of adjuvant trastuzumab benefit in N9831 patients using the ASCO/CAP HER2-positivity criteria. J Natl Cancer Inst. 2012 Jun 20;104(12):957-8. PMID: 22581974. Letter to the Editor.

146. Jochelson M, Hayes DF, Ganz PA. Surveillance and monitoring in breast cancer survivors: maximizing benefit and minimizing harm. Am Soc Clin Oncol Educ Book, 2013;2013:13-8. Doi: E10. 1200/EdBook_AM.2013.33.e13. PMID: 23714444.

147. Bidard FC, Fehm T, Ignatiadis M, Smerage JB, Alix-Panabières C, Janni W, Messina C, Paoletti C, Müller V, Hayes DF, Piccart M, Pierga JY. Clinical application of circulating tumor cells in breast cancer: overview of the current interventional trials. Cancer Metastasis Rev. 2013 Jun;32(1-2):179-88. PMID: 23129208. PMCID: PMC3655223.

148. Neven P, Joensuu H, Osborne K, Cardoso F, Loibl S, Linn S, Goldhirsch A, Ortmann O, Senn HJ, Hayes DF. Tamoxifen therapy for patients with breast cancer. Lancet. 2013 Jun 15;381(9883);2078. PMID: 23769226. Correspondence.

Correspondence response to: Davies C, et al. Long-term effects of continuing adjuvant tamoxifen to 10 years versus stopping at 5 years after diagnosis of oestrogen receptor-positive breast cancer: ATLAS, a randomised trial. The Lancet, 9-15 March 2013:381(9869);805-816.

149. Rae JM, Regan M, Leyland-Jones B, Hayes DF, Dowsett M. CYP2D6 genotype should not be used for deciding about Tamoxifen therapy in postmenopausal breast cancer. J Clin Oncol. 2013 Jul 20;31(21):2753-5. PMID: 23775974. Correspondence.

150. Theriault RL, Carlson RW, Allred C, Anderson BO, Burstein HJ, Edge SB, Farrar WB, Forero A, Giordano SH, Goldstein LJ, Gradishar WJ, Hayes DF, Hudis CA, Isakoff SJ, Ljung BM, Mankoff DA, Marcom PK, Mayer IA, McCormick B, Pierce LJ, Reed EC, Schwartzberg LS, Smith ML, Soliman H, Somlo G, Ward JH, Wolff AC, Zellars R, Shead DA, Kumar R. Breast Cancer, Version 3.2013. J Natl Compr Canc Netw. 2013 Jul 1;11(7):753-761. PMID: 23847214.

151. Hayes DF, Paoletti C. Circulating tumour cells: insights into tumour heterogeneity. J Intern Med. 2013 Aug;274(2):137-43. PMID: 23844916.

152. Hayes DF. From genome to bedside: are we lost in translation? Breast. 2013 Aug;22 Suppl 2:S22-6. PMID: 24074786.

153. Goldhirsch A, Winer EP, Coates AS, Gelber RD, Piccart-Gebhart M, Thürlimann B, Senn HJ; Panel members. Personalizing the treatment of women with early breast cancer: highlights of the St. Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2013. Ann Oncol. 2013 Sep;24(9):2206-23. Epub 2013 Aug 4. PMID: 23917950.

154. Hayes DF. Sitting with grandma. J Clin Oncol. 2013 Nov 1;31(31):4022-3. PMID: 24062401.

155. Jochelson M, Hayes DF, Ganz PA. Surveillance and monitoring in breast cancer survivors: maximizing benefit and minimizing harm. Am Soc Clin Oncol Educ Book. 2013. PMID: 23714444.

156. Hayes DF. OMICS-based personalized oncology: if it is worth doing, it is worth doing well! BMC Med. 2013 Oct 17;11:221. PMID: 24228698.

157. Paoletti C, Hayes DF. Molecular testing in breast cancer. Ann Rev Med. 2014;65:95-110. Review. PMID: 24422569. (No Federal support cited.).

158. Hayes DF, Markus HS, Leslie RD, Topol EJ. Personalized medicine: risk prediction, targeted therapies and mobile health technology. BMC Med. 2014 Feb 28;12:37. PMID: 24580858. PMCID: PMC3938085.

159. Gradishar WJ, Anderson BO, Blair SL, Burstein HJ, Cyr A, Elias AD, Farrar WB, Forero A, Giordano SH, Goldstein LJ, Hayes DF, Hudis CA, Isakoff SJ, Ljung BM, Marcom PK, Mayer IA, McCormick B, Miller RS, Pegram M, Pierce LJ, Reed EC, Salerno KE, Schwartzberg LS, Smith ML, Soliman H, Somlo G, Ward JH, Wolff AC, Zellars R, Shead DA, Kumar R. Breast cancer version 3.2014. J Natl Compr Canc Netw. 2014 Apr 1;12(4):542-90. PMID: 24717572.

160. Hayes DF. Biomarker validation and testing. Mol Oncol. 2014 Oct 18 [Epub ahead of print]. PMID: 25458054.

161. Henry NL, Schott AF, Hayes DF. Assessment of PIK3CA mutations in human epidermal growth factor receptor 2-positive breast cancer: Clinical validity but not utility. J Clin Oncol. 2014. 32(29):3207-9. Editorial. (No Federal support cited).

162. Wolff AC, Hammond EH, Hicks DG, Dowsett M, Hayes DF, McShane LM. Reply to R. Bhargava et al and K. Lambein et al. J Clin Oncol. 2014 June 10;32(17):1857-9. Correspondence. PMID: 24778389. (No Federal support cited.)

163. Yu PP, Hoffman MA, Hayes DF. Biomarkers and oncology: the path forward to a learning health system. Arch Pathol Lab Med. 2014 Aug 25. [Epub ahead of print]. PMID: 25152310. No Federal support cited.

164. Gradishar WJ, Anderson BO, Blair SL, Burstein HJ, Cyr A, Elias AD, Farrar WB, Forero A, Giordano SH, Goldstein LJ, Hayes DF, Hudis CA, Isakoff SJ, Ljung BM, Marcom PK, Mayer IA, McCormick B, Miller RS, Pegram M, Pierce LJ, Reed EC, Salerno KE, Schwartzberg LS, Smith ML, Soliman H, Somlo G, Ward JH, Wolff AC, Zellars R, Shead DA, Kumar R. Breast cancer, version 3.2014: featured updates to the NCCN guidelines. J Natl Compr Canc Netw. 2014 Apr;12(4):542-90. PMID: 24717572. (No Federal support cited.).

165. Fitzgibbons PL, Dillon DA, Alsabeh R, Berman MA, Hayes DF, Hicks DG, Hughes KS, Nofech-Mozes S. Template for reporting results of biomarker testing of specimens from patients with carcinoma of the breast. Arch Pathol Lab Med. 2013 Nov 15. PMID: 24236805.

Books, edited:

1. Hayes DF. Atlas of Breast Cancer. London: Mosby Europe Limited, 1993.

2. Hayes DF. Tumor Markers in Adult Solid Malignancies. Hematology/Oncology Clinics of North America. 1994; 8:3

3. Hayes DF. Atlas of Breast Cancer, Second Edition. London: Mosby Europe Limited, 2000.

4. Hayes DF. Ed: Breast Cancer Section. Up-To-Date in Adult Primary Care and Internal Medicine, 2000–present.

5. Hayes DF. Ed: Classic Papers and Current Comments: Highlights of Breast Cancer Research. Classic Papers and Current Comments from the J Clin Oncol. Baltimore, Lippincott Williams & Williams, 2001.

6. Robertson JF, Nicholson RI, Hayes DF. Endocrine Management of Breast Cancer. Martin Dunitz Ltd. London, England, 2002.

7. Gasparini G and Hayes DF. Ed: Biomarkers in Breast Cancer: Molecular Diagnostics for Predicting and Monitoring Therapeutic Effect. Humana Press, Totowa, New Jersey, 2006.

8. Chang AE, Ganz PA, Hayes DF, Kinsella TJ, Pass HI, Schiller JH, Stone RM, and Strecher VJ. Ed: Oncology: An Evidence-Based Approach. Springer Science+Business Media, Inc., New York, New York, 2006.

Abstracts:

1. Hayes DF, Wittebort RJ, Lehman LD, and Gurd RS. In vitro inhibition of aminopeptidase M by a carbon dioxide bicarbonate-carbonate buffer system: Possible regulatory significance for the biological effects of angiotensin and bradykinin. FASEB Proc. 1977; 36:452a.

2. Matthew JB, Wittebort JR, Hayes DF, Rothgeb TM, Gurd RS, and Gurd FRN. The reaction of CO2 with amino groups in model systems, peptide hormones, and hemoglobin. Proc 174th American Chemical Society meeting. 1977; aps. no. 92.

3. Zalutsky MR, Noska M, Kaplan WD, Hayes D, Colcher D, Schlom J, and Kufe D. Biokinetics of a radio-iodinated antibreast carcinoma monoclonal antibody and fragment in humans. Journal of Nuclear Medicine. 1984; 25:17a.

4. Kufe DW, Ohno T, Hayes D, Abe M, and Sekine H. A double-determinant radioimmunoassay useful in detecting elevated plasma DF3 antigen levels in breast cancer patients. 7th Annual San Antonio Breast Cancer Symposium. 1984; 335a.

5. Hayes DF, Zurawski V, and Kufe DW. Comparison of circulating breast cancer associated antigen CA15-3 with CEA in patients with breast cancer. Proc Am Soc Clin Oncol. 1986; 5:12a.

6. Friedman EL, Hayes DF, and Kufe DW. Immunodiagnostic approaches to ovarian cancer. Proc Am Soc Clin Oncol. 1986; 27:331a.

7. Zalutsky MR, Hayes DF, and Kufe DW. Radioiodination of DF3 antibody: optimization using in vitro binding assays. J. Labeled Compounds and Radiopharmaceuticals. 1986; 23:1301–1303a.

8. Hayes DF, Tondini CA, Henderson IC, and Kufe DW. CA15-3 and related antigens as serum markers for monitoring breast cancer. Giornale Veneto di Scienze Med. 1987; 39:36a.

9. Tondini C, Hayes DF, Gelman R, Henderson IC, and Kufe DW. Comparison of CA15-3 and CEA in monitoring the clinical course of patients with metastatic breast cancer. Proc Am Soc Clin Oncol. 1988; 7:13a.

10. Hayes DF, Kiang DT, Korzun A, Tondini C, Wood W, and Kufe D. CA15-3 and CEA spikes during chemotherapy for metastatic breast cancer. Proc Am Soc Clin Oncol. 1988; 7:38a.

11. Hayes DF, Carney W, Tondini C, Petit D, Henderson IC, and Kufe DW. Elevated circulating c-neu oncogene product in patients with breast cancer. Breast Cancer Res Treat. 1989; 14:135a.

12. Demetri GD, Hayes DF, Shapiro C, Parker L, Merica EA, and Henderson IC. Dose-intensification of mitoxantrone with adjunctive G-CSF (filgrastim) in patients with advanced breast cancer: A Phase I trial. Am Soc Hematol. 1992; 1992a.

13. Nguyen M, Watanabe H, Budson A, Richie JP, Hayes DF, and Folkman J. Basic fibroblast growth factor (bFGF) is elevated in the urine of patients with a wide variety of neoplasms. Mol Biol Cell. 1992; 3:234A.

14. Hayes DF, Cirrincione C, Carney W, Rodrigue S, Berry D, Younger J, Panasci L, Millard F, Duggan D, Henderson IC, and Kufe DW. Elevated circulating HER-2/neu related protein (NRP) is associated with poor survival in patients with metastatic breast cancer. Proc Am Soc Clin Oncol. 1993; 58a.

15. Demetri GD, Younger J, Henderson IC, Shapiro CL, Renaud RC, Colecchi CH, Tomita-Cameron D, Russell TL, Malta E, and Hayes DF. A Phase I study of dose- and schedule-intensified CAF chemotherapy with adjunctive filgrastim (r-metHuG-CSF) in patients with advanced breast cancer. Proc Am Soc Clin Oncol. 1993; 12:72.

16. Li V, Yu C, Rupnick M, Allred E, Sallan S, Hayes DF, and Folkman J. Serum from breast cancer patients contains proliferative activity for capillary endothelial cells which correlates with risk of mortality. Proc Am Soc Clin Oncol. 1993; 12:113a.

17. Demetri G, Costa J, Hayes D, Sledge G, Galli S, Hoffman R, Merica E, Rich W, Harkins B, McGuire B, and Gordon M. A Phase I trial of recombinant methionyl human stem cell factor (SCF) in patients with advanced breast carcinoma pre- and post-chemotherapy (CHEMO) with cyclophosphamide © and doxorubicin (A). Proc Am Soc Clin Oncol. 1993; 12:142a.

18. Costa JJ, Demetri GD, Hayes DF, Merica EA, Menchaca DM, and Galli SJ. Increased skin mast cells and urine methyl histamine in patients receiving recombinant methionyl human stem cell factor. Proc Am Acad Cancer Res. 1993; 34:211a.

19. Demetri GD, Gordon M, Hoffman R, Hayes DF, Sledge G, Sullivan S, Edwards R, Merica E, Battiato L, and Griffin JD. Effects of recombinant methionyl human stem cell factor on hematopoietic progenitor cells in vivo: Preliminary results from a Phase I trial. Proc Am Acad Cancer Res. 1993; 34:217a.

20. Shapiro CL, Dezube BJ, Wright J, Renaud R, Gelman R, Rosowsky A, Tretyakova O, Hayes DF, Frei III E, and Henderson IC. Phase I/II trial of thiotepa (T) and pentoxifylline (P) in advanced breast cancer patients (pts). Proc Am Acad Cancer Res. 1993; 34:284a.

21. LeBoff MS, Janicek M, Angell JE, Blumsack R, Hayes D, and Shapiro CL. Monitoring bone metastases in breast cancer patients using dual X-ray absorptiometry. Am Soc Bone Mineral Res. 1993;

22. Costa JJ, Demetri GD, Harrist TJ, Dvorak AM, Hayes DF, Merica EA, Menchaca DM, Gringeri AJ, and Galli SJ. Recombinant human stem cell factor (rhSCF) induces cutaneous mast cell activation and hyperplasia, and hyperpigmentation in humans in vivo. J Allergy Immunol. 1993;

23. Li V, Yu C, Rupnick M, Allred E, Sallan S, Hayes DF, and Folkman J. Serum from breast cancer patients contains proliferative activity for capillary endothelial cells which correlates with risk of mortality. Proc Am Soc Clin Oncol. 1993; 12:113a.

24. Demetri GD, Renaud R, Blumsack R, Gelman R, and Hayes DF. Combination cytokine support of dose-intensified cyclophosphamide/doxorubicin (CD) chemotherapy with concomitant G-CSF (G) plus erythropoietin (EPO). Proc Am Soc Clin Oncol. 1994;

25. Demetri GD, Berenson RJ, Cap B, Blumsack R, Shapiro T, Austin E, Sugrue M, and Hayes DF. CD34+ selected peripheral blood progenitor cells (PBPCs) to support the delivery of multiple cycles of dose-intensive cyclophosphamide and doxorubicin (CD) with G-CSF plus erythropoietin (EPO) in chemotherapy-naive breast cancer patients. Blood. 1994; 84:207a.

26. Demetri GD, Hayes DF, Merica EA, Cap B, and Sparano J. Concurrent IL-6 + G-CSF to support dose-intensified cyclophosphamide/doxorubicin (CD): Possible acceleration of hematologic recovery from chemotherapy-induced thrombocytopenia. Blood. 1994; 84:28a.

27. Shapiro CL, Hurd D, Clark P, Demetri GD, Ayash L, Blumsack R, Gelman R, Cruz J, Antman K, Elias A, Hayes D, Duggan D, and Henderson IC. Repetitive cycles of cyclophosphamide, thiotepa, and carboplatin (CTCb) intensification with peripheral blood progenitor cells (PBPC) and filgrastim (G-CSF) in advanced breast cancer patients (pts), Proc Am Soc Clin Oncol. 1994;

28. Harrigan P, Otis D, Recht A, Gelman R, Hauptman P, Hayes D, Henderson IC, Harris JR, and Shapiro C. The effect of adjuvant radiation therapy on cardiac events in breast cancer patients treated with doxorubicin. Proc Am Soc Clin Oncol. 1995; 14:102a.

29. Pegram M, Lipton A, Pietras R, Hayes D, Weber B, Baselga J, Tripathy D, Twaddell T, Glaspy J, and Slamon D. Phase II study of intravenous recombinant humanized anti-p185 her-2/neu overexpressing metastatic breast cancer. Proc Am Soc Clin Oncol. 1995; 14:106a.

30. Hayes DF, Van Zyl J, Hacking A, Goedhals L, Bezwoda W, Mailliard J, Jones SE, Vogel CL, Berris RF, Shemano I, and Schoenfelder J. A randomized comparison of tamoxifen and two separate doses of toremifene in postmenopausal patients with metastatic breast cancer. Proc Am Soc Clin Oncol. 1995; 14:93a.

31. Legler CM, Shemano I, Schoenfelder J, and Hayes DF. Effect of prior tamoxifen (TAM) on response to TAM & toremifene (TOR) in metastatic breast cancer. Proc Am Soc Clin Oncol. 1995; 14:91a.

32. Harrist TJ, Costa JJ, Demetri GD, Dvorak AM, Hayes DF, Merica EA, Menchaca D, Gringeri AJ, and Galli SJ. Recombinant human stem cell factor (SCF) (c-kit ligand) promotes melanocyte hyperplasia and activation in vivo. Lab Invest. 1995; 72:49a.

33. Harrigan PM, Recht A, Payne S, Come S, Hayes DF, Shulman L, O’Neill A, Gelman R, Silver B, and Harris J. Treatment-related cardiac toxicity from doxorubicin and radiation therapy in patients treated with breast-conserving therapy. Intl J Rad Oncol. 1996; 36:182a.

34. Watanabe M, Wallace P, Graziano R, Deo Y, Kufe DW, and Hayes DF. Antibody dependent cellular phagocytosis (ADCP) against HER-2/neu positive human breast cancer cells mediated by be specific monoclonal antibody MDX-210. Breast Cancer Res Treat. 1996; 41:247a.

35. Ravdin P, Green S, Albain K, Boucher V, Ingle J, Pritchard K, Shepard L, Davidson N, Hayes DF, Clark G, Martino S, Osborne C, and Allred C. Initial report of the SWOG biological correlative study of c-erbB-2 expression as a predictor of outcome in a trial comparing adjuvant CAF T with tamoxifen alone. P Proc Am Soc Clin Oncol. 1998; 17:97a.

36. Stearns V, Isaacs C, Crawford J, Galassi A, Ellis MJ, Hanfelt J, and Hayes DF. A pilot trial assessing the efficacy of Paroxetine hydrochloride in controlling hot flashes. Breast Cancer Res Treat. 1998; 50:308.

37. Baidas S, Isaacs C, Crawford J, Winer E, Flemning G, Harris L, Pluda J, Hawkins M, Lippman L, and Hayes DF. A phase Ii evaluation of thalidomide in patients with metastatic breast cancer. Proc Am Soc Clin Oncol. 1999; 18:125a.

38. Dressler L, Berry D, Liu E, Cowan D, Broadwater G, Tse J, Cox-Jones K, Griffith S, Miller A, Persons D, Novotny D, Muss H, Norton L, and Hayes D. Amplification of erbB-2 by fluorescent in situ hybridization (FISH): An alternate method to predict outcome following dose-escalated CAF in Stage II, node positive breast cancer patients. A Cancer and Leukemia Group B (CALGB) study. Proc Am Soc Clin Oncol. 1999; 43:68–72.

39. Muss H, Berry D, Thor A, Liu E, Edgerton S, Budman D, Wood W, Henderson IC, Cirricnione C, Hayes D, Barcos M, and Norton L. Lack of interaction of tamoxifen use and erbB-2/Her-2/neu expression in CALGB 8541: A randomized adjuvant trial of three different doses of cyclophosphamide, doxorubicin, and fluorouracil (CAF) in node-positive primary breast cancer. Proc Am Soc Clin Oncol. 1999; 18:68a.

40. Meehan KR, Ballen K, Boccia R, Ahmed U, Hill JM, Herscowitz H, Geehan E, Hayes DF, and Lippman ME. A phase III multicenter randomized trial comparing cyclophosphamide, thiotepa and carboplatin (stamp V) with or without IL-2 activated stem cell transplantation and parenteral IL-2 for high-risk breast cancer. Proc Am Soc Hematol, 1999; 94:352a.

41. Chen HX, Marshall JL, Trocky N, Ling Y, Baidas S, Rizvi N, Bhagava P, Lippman ME, Yang D, and Hayes DF. A phase I study of BCL-2 antisense G3139; (Genta) and weekly docetaxel in patients with advanced breast cancer and other solid tumors. Proc Am Soc Clin Oncol. 2000; 19:178a.

42. Baidas S, Bhargava P, Isaacs C, Rizvi N, Trocky N, Pipkin T, Hayes DF, and Marshall J. Phase I study of the combination of TNP-470 and paclitaxel patients with advanced cancer. Proc Am Soc Clin Oncol. 2000; 19:205a.

43. Trock BJ, Yamauchi H, Brotzman M, Stearns V, and Hayes DF. C-ERBB2 as a prognostic factor in breast cancer (BC): A Meta-Analysis. Proc Am Soc Clin Oncol. 2000; 19:97a.

44. Kantoff P, Halabi S, Farmer D, Hayes DF, Vogelzang N, and Small E. RT-PCR for prostate specific antigen (PSA) in peripheral blood (PB) predicts survival duration in patients with hormone refractory prostate cancer (HRPC) – a CALGB study. Proc Am Soc Clin Oncol. 2000; 19:336a.

45. Ellis MJ, Coop A, Singh B, Lieberman R, Gallagher A, Tsangaris T, Trock B, Hayes DF, and Pennanan MF. A pilot clinical trial of perillyl alcohol (POH) in breast neoplasia. Administration during the period between diagnostic biopsy and definitive surgery. Proc Am Assoc Cancer Res. 2000; 41:574.

46. Stearns V, Crawford J, Novielli A, Ellis M. Isaacs C, Pennanen M, Tsangaris T, Slack R, Singh B, and Hayes DF. A pilot trial comparing doxorubicin and paclitaxel induced apoptosis in locally advanced breast cancer. Proc Am Soc Clin Oncol. 2000; 19:92a.

47. Tsangaris TN, Stearns V, Pennanen MF, Slack RS, and Hayes DF. A pilot evaluation of sentinel lymphadenectomy following neoadjuvant chemotherapy for locally advanced breast cancer. Proc Am Soc Clin Oncol. 2000; 19:143a.

48. Taplin ME, Rajeskumar B, Woda BA, Halabi S, Prins GS, Picus J, Hayes DF, Vogelzang NJ, and J. SE. Androgen receptor analysis in androgen independent prostate cancer: Cancer and Leukemia Group B 9663. Proc Am Soc Clin Oncol. 2000; 19:330a.

49. Bok R, Halabi S, Shaal M, Fei D, Rodriguez C, Hayes DF, Vogelzang NJ, and Small EJ. VEGF and basic FGF urine levels as predictors of response to therapy with suramin in CALGB 9480, a phase III study of hormone refractory prostate cancer patients. Proc Am Soc Clin Oncol. 2000; 19:347a.

50. Lawrence WF, Liang W, Hwang Y, Mandelblatt J, Bhargava P, Isaacs C, Hayes DF, and Marshall JL. Quality of life in a phase I trial of TNP-470 and paclitaxel in patients with advanced breast cancer. Proc Am Soc Clin Oncol. 2000; 19:632a.

51. Stone ER, Slack RS, Novielli A, Ellis M, Baidas S, Gelmann E, Cohen P, Warren R, Stearns V, Hayes DF, and Isaacs C. Rate of chemotherapy related amenorrhea (CRA) associated with adjuvant adriamycin and cytoxan (AC) and adriamycin and cytoxan followed by taxol (AC+T) in early stage breast cancer. San Antonio Breast Cancer Symp. 2000; 224.

52. Esteva FJ, Glaspy JA, Baidas S, Laufman LR, Hutchins LF, Dickler MN, Tripathy D, Cohen R, DeMichele A, Youcm R, Hayes DF, Osborne CK, Hortobagyi GN, and Demetri GD. Multicenter phase II study of oral bexarotene for patients with metastatic breast cancer. Proc Am Soc Clin Oncol. 2002; 20:51(a).

53. Clark PM, Michael CW, Merajver SD, Smith GL, Griffith KA, Milliron KJ, Schott AF, Kiehl DM, Cimmino VM, Sabel MS, and Hayes DF. Dutcal lavage specimens can be successfully split at the bedside without compromising cytologic diagnosis. San Antonio Breast Cancer Symp. 2003.

54. Clark PM, Michael CW, Merajver SD, Smith GL, Griffith KA, Milliron KJ, Schott AF, Kiehl KM, Cimmino VM, Sabel MS, and Hayes DF. Ductal lavage specimens can be successfully split at the bedside without compromising cytologic diagnosis. Breast Cancer Res Treat. 82:S174a, 2003.

55. Stearns V, Hayes DF, Jin Y, Ullmer L, Nguyen A, Storniolo AM, Flockhart D, and Desta Z. The effect of CYP 2D6 genotype and CYP 2D6 inhibitors on tam oxifen. Proc Am Soc Clin Oncol. 2004; 23:5 (abstract 508).

56. Rehman MI, Bermes A, Lee K, Skaar T, Arefayene M, Li L, Stearns V, Flockhart DA, and Hayes DF. ER-alpha and ER-beta genotypes predict tamoxifen effects on serum lipids in breast cancer patients. Clin Pharmacol Ther. 2004; 75(2):P2.

57. Rehman MI, Lee K, Bermes A, Skaar T, Arefayene M, Li L, Stearns V, Hayes DF, and Flockhart DA. CYP genotypes influence the effect of tamoxifen therapy on serum lipids. Clin Pharmacol Ther. 2004; 75(2):P69.

58. Hayes DF, Miller MC, Cristofanilli M, Ellis MJ, Stopek A, Allard WJ, Matera J, Doyle GV, Terstappen LWWM, and Budd GT. Circulating tumor cells are a reliable predictor of progression free survival and overall survival during therapy of patients with metastatic breast cancer. Breast Cancer Res Treat. 2004; 88 Supplement 1:S225.

59. Cristofanilli M, Reuben JM, Fritsche HA, Hayes DF, Budd TG, Ellis MJ, Stopeck A, Miller CM, Matera J, Allard JW, and Terstappen LWMM. Detection of circulating tumor cells (CTCs) is a prognostic factor in first-line metastatic breast cancer (MBC). Breast Cancer Res Treat. 2004; 88 Supplement 1:S225.

60. Budd GT, Cristofanilli M, Terstappen LW, Ellis MJ, Stopeck A, Allard WJ, Matera J, Miller MC, Doyle GV, and Hayes DF. Correlation of changes in circulating tumor cells and radiographic response to treatment in patients with metastatic breast cancer. Breast Cancer Res Treat. 2004; 88 Supplement 1:S226.

61. Yan J, Hu Z, Nguyen A, Skaar T, Flockhart D, Hayes DF, and Stearns V. Estrogen receptor (ER) genotype predicts hot flash scores in patients with breast cancer. Breast Cancer Res Treat. 2004; 88 Supplement 1:S233.

62. Nguyen AT, Jin Y, Rehman M, Li L, Skaar TC, Stearns V, Hayes DF, and Flockhart DA. Pharmacogenetic variants influence tamoxifen’s estrogenic effect on bone density: PI-50. Clin Pharmacol Ther. 2005; 77:P21.

63. Ellis MJ, Miller MC Cristofanilli M, Budd GT, Stopeck A, Hayes DF, Doyle, GV, Matera J, and Terstappen LWMM. Prognostic and predictive value of circulating tumor cells in metastatic breast cancer patients treated with endocrine or chemotherapy. Breast Cancer Res Treat. 2005; 94 Supplement 1:S7.

64. Ntukidem NI, Schott A, Skaar T, Jin Y, Li L, Lemler S, Nguyen A, Hayden J, Desta Z, Flockhart DA, and Hayes DF. Estrogen receptor genotypes predict the response of serum cholesterol to tamoxifen treatment. Breast Cancer Res Treat. 2005; 94 Supplement 1:S47.

65. Gown AM, Treaba DO, Goldstein LC, Porter PL, Gralow JR, Livingston RB, Tam S, Yeh I-T, Hayes DF, Barlow W, and Lew D. HIGH expression of the microtubule-associated protein, tau, strongly predicts improved progression free and overall survival in patients with metastatic HER-2-negative breast cancers treated with docetaxel and vinorelbine plus filgrastim. Breast Cancer Res Treat. 2005; 94 Supplement 1:S50.

66. Schott AF, Thomas DG, Griffith KA, Smerage JB, and Hayes DF. Evaluation of thymidine phosphorylase (TP) in primary breast cancer treated with docetaxel (D) and capecitabine (C). Breast Cancer Res Treat. 2005; 94 Supplement 1:S54.

67. Cimprich B, Hayes DF, Therrien B, Reuter-Lorenz P, Noll D, Normolle D, Welsh R, Clark PM, Vincent C, and Nelson J. Pre-chemotherapy assessment of cognitive function using functional magnetic brain imaging in women with breast cancer. Breast Cancer Res Treat. 2005; 94 Supplement 1:S277.

68. Hwang J, Jin Y, Storniolo AM, Hayes DF, Li L, Stearns V, Skaar TC, and Flockhart DA. Influence of serotonin related genes on tamoxifen induced hot flashes and responsiveness to selective serotonin reuptake inhibitors: PII–21. Clin Pharmacol Ther. 2006; 79:P42.

69. Ntukidem NI, Li L, Rehman MI, Skaar TC, Jin Y, Desta Z, Storniolo AM, Stearns V, Hayes DF, and Flockhart DA. Estrogen receptor genotypes are associated with response of serum cholesterol to tamoxifen treatment: PII–18. Clin. Pharmacol. Ther. 2006; 79:P40.

70. Ntukidem NI, Blanche P, Li L, Krauss RM, Skaar TC, Desta Z, Storniolo AM, Stearns V, Hayes DF, and Flockhart DA. The effect of tamoxifen treatment on LDL subfraction particle size in breast cancer patients: PI–29. Clin Pharmacol Ther.2006; 79:P15.

71. Smerage JB, Doyle G, Budd GT, Schott AF, Blayney DW, Wicha MS, Repollet M, Terstappen LWMMT, and Hayes DF. The detection of apoptosis and Bcl-2 expression in circulating tumor cells (CTCs) from women being treated for metastatic breast cancer. Proc Am Assoc Cancer Res. 2006; 47:187.

72. Hayes DF, Thor A, Dressler L, Weaver D, Broadwater G, Goldstein L, Martino S, Ingle J, Henderson IC, and Berry D. HER2 predicts benefit from adjuvant paclitaxel after AC in node-positive breast cancer: CALGB 9344. Proc Am Soc Clin Oncol. 2006; 47:187.

73. Eliane JP, Repollet M, Luker KE, Brown M, Rae JE, Doyle GV, Hayes DF, Luker GD. Dynamics of circulating tumor cells in mice bearing human breast cancer xenografts. Proc Am Assoc Canc Res (AACR) 2008; Session Category: Tumor Biology 28: Session Title: Determinants of Metastasis: Session Type: Poster Session, Section 12.