Long Title: ATNEC – Axillary management in T1-3N1M0 breast cancer patients with needle biopsy proven nodal metastases at presentation after neoadjuvant chemotherapy.

Trial summary:

The primary objectives are to assess whether, omitting further axillary treatment (either ALND or ART) for patients with early stage breast cancer and axillary nodal metastases on needle biopsy, who after NACT have no evidence of residual cancer in the lymph nodes on SNB, is non-inferior to axillary treatment in terms of disease free survival (DFS), and reduces the risk of lymphoedema at five years.

RT QA summary:

All QA activity will be streamlined with previous trial QA, where applicable. Please contact the RTTQA Group directly using the contact details below to discuss.

QA ProcessQA ActivityRequired for TrialAdditional Details
Pre-AccrualFacility Questionnaire
Outlining Benchmark Case
Planning Benchmark Case
Dummy RunOnly required if change of technique after issuing of approval
During AccrualIndividual Case ReviewProspective review for the first patient randomised to axillary treatment
Data collectionAll patients 10% will be retrospectively reviewed from each site
QA StreamliningRCR breast outlining course

RTTQA contact:

Chief investigator: Mr Amit Goyal, Royal Derby Hospital

RT Lead: Dr Duncan Wheatley, Royal Cornwall Hospitals NHS Trust

Sponsor: University Hospitals of Derby & Burton NHS Foundation Trust,

Funder: Health Technology Assessment (HTA), National Institute for Health Research (NIHR) (HTA NIHR128311)