Axillary Management in Breast Cancer Patients With Needle Biopsy Proven Nodal Metastases After Neoadjuvant Chemotherapy
ATNEC - Axillary Management in T1-3N1M0 Breast Cancer Patients With Needle Biopsy Proven Nodal Metastases at Presentation After Neoadjuvant Chemotherapy
University Hospitals of Derby and Burton NHS Foundation Trust
1,900 participants
Feb 26, 2021
INTERVENTIONAL
Conditions
Summary
The aim of this study is to assess whether, omitting further axillary treatment (ALND and ART) for patients with early stage breast cancer and axillary nodal metastases on needle biopsy, who after NACT have no residual cancer in the lymph nodes on sentinel node biopsy, is non-inferior to axillary treatment in terms of disease free survival (DFS) and results in reduced risk of lymphoedema at 5 years.
Eligibility
Inclusion Criteria15
- cT1-3N1M0 breast cancer at diagnosis (prior to NACT) by American Joint Committee on Cancer (AJCC) staging 8th edition
- Patients with occult primary breast cancer (no identifiable invasive cancer in the breast) with FNA or core biopsy proven nodal metastases are also eligible for the study.
- Fine-needle aspiration (FNA) or core biopsy confirmed axillary nodal metastases at presentation
- Oestrogen receptor and HER2 status evaluated on primary tumour
- Received standard NACT as per local guidelines (Patients undergoing neoadjuvant endocrine therapy as part of another clinical trial are eligible)
- Imaging of the axilla, as required, to assess response to NACT (per local guidelines)
- Undergo a dual tracer sentinel node biopsy (SNB) after NACT with at least 3 nodes removed in total (sentinel nodes and marked node).
- If a single tracer SNB is performed, the patient is eligible only if the involved node is marked before or during NACT, and at least 3 nodes (including the marked node) are removed during sentinel node biopsy.
- If the node is not marked, or the marked node is not removed, the patient is eligible only if the histology report shows evidence of down-staging with complete pathological response e.g. fibrosis or scarring in at least one node and at least 3 nodes removed.
- If fewer than 3 nodes are found on histology, the patient is eligible only if BOTH points a) and b) below, are met:
- involved node was marked and removed during SNB; and
- removed marked node shows evidence of downstaging on histology e.g. fibrosis or scarring.
- If the sentinel node(s) cannot be localised on SNB: axillary node sampling should be performed, the patient will be eligible if at least 3 nodes are removed (including the marked node).
- No evidence of nodal metastases post NACT (isolated tumour cells, micro or macro metastasis)
- Patients with complete pathological response in the axilla but residual disease in the breast post NACT are eligible for the study.
Exclusion Criteria8
- Bilateral synchronous invasive breast cancer
- Sentinel node biopsy prior to NACT
- Previous axillary surgery on the same body side as the scheduled targeted sampling
- Any previous cancer within 5 years 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
Interventions
Participants will undergo removal of at least level I and II axillary lymph nodes.
Axillary radiotherapy will be delivered as per the Radiotherapy Trials Quality Assurance (RTTQA) guidelines.
Breast or chest wall radiotherapy will be delivered as per the Radiotherapy Trials Quality Assurance (RTTQA) guidelines.
Locations(98)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04109079