Breast Cancer Drug Development Pipeline Analysis 2025

DelveInsight's comprehensive "Breast Cancer Pipeline Insight 2025" analysis delivers thorough insights about over 250 Breast Cancer organizations and more than 300 investigational medications within the Breast Cancer development landscape. The report encompasses drug candidate profiles across both clinical and preclinical phases, offering therapeutic evaluations organized by product category, developmental phase, administration method, and molecular classification. Additionally, it spotlights dormant pipeline candidates in this therapeutic area.

Discover the latest drugs and treatment alternatives in the Breast Cancer Pipeline through DelveInsight's comprehensive analysis! @ Breast Cancer Pipeline Outlook

Major Highlights from the Breast Cancer Pipeline Analysis

As of December 10, 2025 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), disclosed positive Phase III outcomes from the lidERA Breast Cancer investigation evaluating investigational giredestrant as an adjuvant endocrine therapy for individuals diagnosed with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2-negative, early-stage breast cancer. At the pre-specified interim analysis, giredestrant demonstrated a 30% reduction in the risk of invasive disease recurrence or death (invasive disease-free survival, iDFS) compared with standard-of-care endocrine therapy, achieving a hazard ratio of 0.70 (95% CI: 0.57–0.87; p=0.0014). These findings are being presented at the 2025 San Antonio Breast Cancer Symposium and are featured in the event's official press program.

As of December 05, 2025 - Bristol-Myers Squibb disclosed a study to assess the efficacy and safety of iza-bren, a bi-specific antibody-drug conjugate against EGFR and HER3 with a topoisomerase inhibitor payload versus treatment of physician's choice (TPC) (paclitaxel, nab-paclitaxel, carboplatin plus gemcitabine, and capecitabine) for managing first-line metastatic triple-negative breast cancer (TNBC) or estrogen receptor (ER)-low, human epidermal growth factor receptor 2 (HER2)-negative BC patients who are not candidates for anti-PD(L)1 therapy and endocrine therapies.

As of December 04, 2025 - Merck Sharp & Dohme LLC performed a study to learn if individuals who receive patritumab deruxtecan (also known as HER3-DXd and MK-1022) live longer overall or without the cancer growing/spreading, compared to individuals who receive chemotherapy or a different drug called trastuzumab deruxtecan.

DelveInsight's Breast Cancer pipeline analysis reveals a dynamic field with over 250 Breast Cancer organizations advancing more than 300 investigational therapies for Breast Cancer management.

Premier Breast Cancer pharmaceutical organizations include Tanvex Biopharma, Sichuan Kelun-Biotech Biopharmaceutical, Shanghai Henlius Biotech, Byondis, CSPC Ouyi Pharmaceutical Co., Ltd., Pfizer, Jazz Pharmaceuticals, Biostar Pharma, Inc., Chia Tai Tianqing Pharmaceutical Group, InventisBio, Coherent Biopharma, Shanghai Jiaolian Drug Research and Development Co., Ltd., Ambrx, MediLink Therapeutics (Suzhou) Co., Ltd., Tasly Pharmaceutical Group, Convalife (Shanghai) Co., Ltd., Merck & Co., AstraZeneca, Aclaris Therapeutics, Boehringer Ingelheim, NovaOnco Therapeutics Co., Ltd., Verastem Oncology, Ellipses Pharma, Shenzhen Yangli Pharmaceutical Technology Co., Ltd., TYK Medicine, Ascendis Pharma, ExpreS2ion Biotechnologies, Mersana Therapeutics, Exelixis, Shenzhen Celconta Life Science, Beijing Wehand-Bio Pharmaceutical, VM Oncology, Hinova Pharmaceuticals, OS Therapies, and Syntab Therapeutics, among others.

Notable Breast Cancer Pipeline investigational agents include Oraxol, ARV-471, Ribociclib, E7389, Trastuzumab, GM-CSF, GM-CSF, Trastuzumab, Paclitaxel, Gemcitabine/Carboplatin, Iniparib, among others.

Stay ahead with the most recent pipeline perspective for Breast Cancer. Access insights into clinical investigations, emerging therapies, and leading organizations with DelveInsight @ Breast Cancer Treatment

The Breast Cancer Pipeline Analysis delivers disease background, pipeline landscape, and therapeutic evaluation of primary pipeline candidates within this therapeutic domain. The analysis also emphasizes unmet medical needs regarding Breast Cancer.

Breast Cancer Disease Background

Breast cancer represents a malignant tumor that originates in the cells of the breast, most commonly in the ducts (ductal carcinoma) or lobules (lobular carcinoma). It is one of the most prevalent cancers among women worldwide, although it can also occur in men. Risk factors include age, family history, genetic mutations such as BRCA1 and BRCA2, hormonal factors, obesity, and lifestyle choices. Breast cancer can range from localized, slow-growing tumors to aggressive types that metastasize to other parts of the body.

Emerging Breast Cancer Drug Candidates Profile

Vepdegestrant (ARV-471): Pfizer/ Arvinas

Vepdegestrant represents an investigational, orally bioavailable PROteolysis TArgeting Chimera (PROTAC) protein degrader engineered to specifically target and degrade the estrogen receptor (ER) for managing patients diagnosed with ER-positive (ER+)/human epidermal growth factor receptor 2 (HER2)-negative (ER+/HER2-) breast cancer. Vepdegestrant is under development as a potential monotherapy for ER+/HER2- advanced or metastatic breast cancer with estrogen receptor 1 (ESR1) mutations in the second line-plus setting. The U.S. Food and Drug Administration (FDA) has granted vepdegestrant Fast Track designation as a monotherapy in managing adults diagnosed with ER+/HER2- advanced or metastatic breast cancer previously treated with endocrine-based therapy. Currently, this drug is in Preregistration stage of development for managing ER+/HER2- Metastatic Breast Cancer, ER+/HER2- Early Breast Cancer.

Utidelone: Biostar Pharma, Inc.

Utidelone (UTD1), developed by Biostar Pharma, represents a genetically engineered epothilone analog and next-generation microtubule inhibitor that received approval in China in March 2021 for metastatic breast cancer. Unlike taxanes, it binds a different site on microtubules, enabling it to overcome taxane resistance, demonstrate strong antitumor activity, and maintain low hematologic toxicity—showing both progression-free survival (PFS) and overall survival (OS) benefits in heavily pretreated patients when combined with capecitabine. Ongoing global trials include expanding indications including neoadjuvant breast cancer, brain metastases, and even oral formulations to enhance convenience and broaden therapeutic impact. Currently, this drug is in Phase III stage of development for managing advanced breast cancer, Breast cancer neoadjuvant and breast cancer brain metastasis.

ARX788: Ambrx, Inc.

ARX788, an anti-HER2 ADC currently being studied broadly in breast cancer, gastric/GEJ cancer and other solid tumor clinical investigations. ARX788 represents a homogeneous and highly stable ADC, which targets the HER2 receptor and contains two AS269 cytotoxic payloads site-specifically conjugated to a trastuzumab-based antibody. ARX788 was designed to maximize potential anti-tumor activity by optimizing the number and position of the payloads and the chemical bonds that conjugate the payloads to the antibody. AS269, proprietary payload, represents a tubulin inhibitor specifically designed to form a highly stable covalent bond with our SAAs and kill tumor cells only upon entry into the cell when aided by the conjugated targeting antibody, thereby limiting off-target effects on healthy tissue. Currently, this drug is in Phase II/III stage of its development for managing Triple Negative Breast Cancer.

TSL-1502: Jiangsu Tasly Diyi Pharmaceutical Co., Ltd.

TSL-1502 represents a pro-drug and its metabolite TSL-1502M has higher localized concentration at cancer sites with more potency, thus, our preclinical studies demonstrated that TSL-1502's anticancer activity is superior to competitor(s) while having a much wider therapeutic window. TSL-1502 represents a small molecule drug, ready for clinical investigation (INDs) under both Chinese FDA (cFDA) and US FDA regulations. A phase II clinical investigation will be managed and conducted in the USA. TSL-1502 is positioned to have strong PCT patent protections. Patents cover chemical structure, chiral auxiliary structures, crystal form, synthesize methods, and all potential indications. Currently, this drug is in Phase II stage of its development for managing HER2-negative Locally Advanced or Metastatic Breast Cancer Patients With Germline BRCA Mutations.

PF-07104091: Pfizer

PF-07104091, also known as tegtociclib, represents a first-in-class, orally administered, selective CDK2 inhibitor under development for managing various advanced solid tumors, with a particular focus on hormone receptor-positive (HR+)/HER2-negative metastatic breast cancer that has progressed after prior CDK4/6 inhibitor therapy. By selectively inhibiting CDK2, PF-07104091 aims to induce cell cycle arrest through reduced phosphorylation of retinoblastoma protein (Rb) and other downstream targets, offering a novel approach to overcoming resistance to existing CDK4/6 inhibitors. Early-phase clinical trials have demonstrated that PF-07104091 is generally well tolerated and shows preliminary antitumor activity in heavily pretreated patients, with ongoing studies evaluating its use both as monotherapy and in combination with other agents including fulvestrant and palbociclib. Currently, this drug is in Phase II stage of its development for managing Breast Cancer.

XL092: Edgewood Oncology Inc.

XL092 represents a third-generation oral tyrosine kinase inhibitor that inhibits the activity of receptor tyrosine kinases implicated in cancer growth and spread, including VEGF receptors, MET, AXL and MER. These receptor tyrosine kinases are involved in both normal cellular function and in pathologic processes including oncogenesis, metastasis, tumor angiogenesis and resistance to multiple therapies, including immune checkpoint inhibitors. Zanzalintinib is currently under development for managing advanced solid tumors, including genitourinary, colorectal and head and neck cancers. This drug is currently being evaluated under Phase I/II stage of development for managing patients suffering from breast cancer.

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Breast Cancer Pharmaceutical Organizations

Tanvex Biopharma, Sichuan Kelun-Biotech Biopharmaceutical, Shanghai Henlius Biotech, Byondis, CSPC Ouyi Pharmaceutical Co., Ltd., Pfizer, Jazz Pharmaceuticals, Biostar Pharma, Inc., Chia Tai Tianqing Pharmaceutical Group, InventisBio, Coherent Biopharma, Shanghai Jiaolian Drug Research and Development Co., Ltd., Ambrx, MediLink Therapeutics (Suzhou) Co., Ltd., Tasly Pharmaceutical Group, Convalife (Shanghai) Co., Ltd., Merck & Co., AstraZeneca, Aclaris Therapeutics, Boehringer Ingelheim, NovaOnco Therapeutics Co., Ltd., Verastem Oncology, Ellipses Pharma, Shenzhen Yangli Pharmaceutical Technology Co., Ltd., TYK Medicine, Ascendis Pharma, ExpreS2ion Biotechnologies, Mersana Therapeutics, Exelixis, Shenzhen Celconta Life Science, Beijing Wehand-Bio Pharmaceutical, VM Oncology, Hinova Pharmaceuticals, OS Therapies, and Syntab Therapeutics, among others.

The Breast Cancer pipeline analysis delivers therapeutic evaluation of pipeline medications by Administration Route:

• Intravenous

• Subcutaneous

• Oral

• Intramuscular

Breast Cancer Products have been organized under various molecular classifications including:

• Monoclonal antibody

• Small molecule

• Peptide

Unveil the future of Breast Cancer Treatment through insights on new drugs, pipeline advancements, and key organizations via DelveInsight's expert analysis @ Breast Cancer Market Drivers and Barriers

Coverage of the Breast Cancer Pipeline Analysis

Coverage: Global

Breast Cancer Pharmaceutical Organizations: Tanvex Biopharma, Sichuan Kelun-Biotech Biopharmaceutical, Shanghai Henlius Biotech, Byondis, CSPC Ouyi Pharmaceutical Co., Ltd., Pfizer, Jazz Pharmaceuticals, Biostar Pharma, Inc., Chia Tai Tianqing Pharmaceutical Group, InventisBio, Coherent Biopharma, Shanghai Jiaolian Drug Research and Development Co., Ltd., Ambrx, MediLink Therapeutics (Suzhou) Co., Ltd., Tasly Pharmaceutical Group, Convalife (Shanghai) Co., Ltd., Merck & Co., AstraZeneca, Aclaris Therapeutics, Boehringer Ingelheim, NovaOnco Therapeutics Co., Ltd., Verastem Oncology, Ellipses Pharma, Shenzhen Yangli Pharmaceutical Technology Co., Ltd., TYK Medicine, Ascendis Pharma, ExpreS2ion Biotechnologies, Mersana Therapeutics, Exelixis, Shenzhen Celconta Life Science, Beijing Wehand-Bio Pharmaceutical, VM Oncology, Hinova Pharmaceuticals, OS Therapies, and Syntab Therapeutics, among others.

Breast Cancer Pipeline Therapeutic Candidates: Oraxol, ARV-471, Ribociclib, E7389, Trastuzumab, GM-CSF, GM-CSF, Trastuzumab, Paclitaxel, Gemcitabine/Carboplatin, Iniparib, among others.

Breast Cancer Therapeutic Evaluation by Product Category: Mono, Combination, Mono/Combination

Breast Cancer Therapeutic Evaluation by Clinical Phases: Discovery, Pre-clinical, Phase I, Phase II, Phase III

Access the latest on Breast Cancer Therapies and clinical investigations through DelveInsight's comprehensive pipeline analysis! @ Breast Cancer Companies, Key Products and Unmet Needs

Report Structure

1. Introduction

2. Executive Summary

3. Breast Cancer: Overview

4. Pipeline Therapeutics

5. Therapeutic Assessment

6. Breast Cancer– DelveInsight’s Analytical Perspective

7. Late Stage Products (Registration)

8. Vepdegestrant (ARV-471): Pfizer/ Arvinas

9. Mid Stage Products (Phase II)

10. PF-07104091: Pfizer

11. Early Stage Products (Phase I/II)

12. XL092: Edgewood Oncology Inc.

13. Preclinical and Discovery Stage Products

14. Drug Name: Company Name

15. Inactive Products

16. Breast Cancer Key Companies

17. Breast Cancer Key Products

18. Breast Cancer- Unmet Needs

19. Breast Cancer- Market Drivers and Barriers

20. Breast Cancer- Future Perspectives and Conclusion

21. Breast Cancer Analyst Views

22. Breast Cancer Key Companies

23. Appendix

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