ATNEC

Status: Open

Specialty: Breast

Date Opened: 24/06/2024

Planned Close Date: 20/12/2025

Sponsor: University Hospitals of Derby and Burton NHS Foundation Trust

Principal Investigator: Mr Bade

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