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 Process | QA Activity | Required for Trial | Additional Details |
|---|---|---|---|
| Pre-Accrual | Facility Questionnaire |  | |
| Outlining Benchmark Case | | ||
| Planning Benchmark Case | | ||
| Dummy Run | Only required if change of technique after issuing of approval | ||
| During Accrual | Individual Case Review | | Prospective review for the first patient randomised to axillary treatment |
| Data collection | | All patients 10% will be retrospectively reviewed from each site | |
| Dosimetry | | ||
| QA Streamlining | | RCR breast outlining course POSNOC PARABLE FAST FORWARD LN-sub study |
RTTQA contact: Atnecqa.enh-tr@nhs.net
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, dhft.sponsor@nhs.net
Funder: Health Technology Assessment (HTA), National Institute for Health Research (NIHR) (HTA NIHR128311)