ATNEC

Axillary ultrasound, with fine needle aspiration (FNA) or core biopsy of suspicious lymph nodes, is used in the initial diagnostic work up of breast cancer patients to document nodal status and staging prior to treatment planning. Patients with FNA or core biopsy positive nodes are often referred for neoadjuvant chemotherapy (NACT) and it is currently the standard to perform axillary lymph node dissection (ALND) at the time of breast surgery after completion of NACT. ALND damages lymphatic drainage from the arm, and women may subsequently develop lymphoedema. As well as the discomfort of arm swelling this causes restricted shoulder movement, pain, numbness and other sensory problems. These adverse effects interfere with daily activities, are distressing, impair quality of life and are costly to the NHS in terms of rehabilitative treatments (such as physiotherapy and lymphoedema clinics), as they are often irreversible and symptom relief is difficult. 

The performance of sentinel node biopsy (SNB) in patients who are node positive before NACT was tested in Z10711and SENTINA2 trials. All patients underwent ALND following SNB. Z1071 showed that the success rate of SNB was 92.5%, 40% of patients had ypN0 disease, and the false‐negative rate (FNR) was 12.6%. The SENTINA study reported 80% success rate of SNB and the FNR was 14%. The FNR decreased when dual mapping agents were used and was less than 10% when ≥3 nodes were removed. Additionally, Z1071 suggested that clip placement at diagnosis of node‐positive disease with removal of the clipped node during SNB reduces the FNR of SNB3. It has been demonstrated that NACT results in eradication of nodal disease in up to 40% of patients. 

Omission of additional axillary surgery in patients with a negative SNB after NACT appears to be logical however the recurrence and survival rates are unknown and there is a risk of under treatment. The next step is to determine in a randomised trial whether...

1. Age ≥ 18

2.  Male or female

3.  T1‐3N1M0 breast cancer at diagnosis (prior to the start of neoadjuvant chemotherapy (NACT)) by AJCC staging 7th edition

4. FNA or core biopsy confirmed axillary nodal metastases at presentation (prior to NACT)

5.  Oestrogen receptor, progesterone receptor and HER2 status evaluated on primary tumour

6. Received standard neoadjuvant chemotherapy as per local guidelines

7.  Ultrasound of the axilla at completion of neoadjuvant chemotherapy

8.  Undergo dual agent targeted sampling after NACT and at least 3 nodes should be removed

9.  No nodal metastases post NACT on axillary surgery 

1.  Bilateral invasive breast cancer

2. Sentinel node biopsy prior to neoadjuvant chemotherapy

3.  Previous axillary surgery on the same body side as the scheduled targeted sampling

4.  Radiation therapy for the currently diagnosed breast cancer prior to randomisation

5.  Previous cancer less than 5 years previously or concomitant malignancy except:

• basal or squamous cell carcinoma of the skin

•  in situ carcinoma of the cervix

• in situ melanoma

• contra‐ or ipsilateral in situ breast cancer 

Research Nurse: Alison Blackburn (alison.blackburn@elht.nhs.uk)

Administrator: Oncology Research Team