Status:
RECRUITING
Axillary Management in Breast Cancer Patients With Needle Biopsy Proven Nodal Metastases After Neoadjuvant Chemotherapy
Lead Sponsor:
University Hospitals of Derby and Burton NHS Foundation Trust
Conditions:
Breast Cancer
Sentinel Lymph Node
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 NAC...
Detailed Description
Background: The presence of cancer in the axillary lymph nodes on needle biopsy in patients with early stage breast cancer before neoadjuvant chemotherapy (NACT) has been the determinant of the need f...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2030
Estimated Enrollment :
1900 Patients enrolled
Trial Details
Trial ID
NCT04109079
Start Date
February 26 2021
End Date
February 28 2030
Last Update
December 22 2025
Active Locations (98)
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1
St Vincent's University Hospital - St Vincent's Healthcare Group
Dublin, Ireland, D04 T6F4
2
St Luke's Hospital - St Luke's Radiation Oncology Network
Dublin, Ireland, D06 HH36
3
Beaumont Hospital - Royal College of Surgeons in Ireland
Dublin, Ireland, D09 V2N0
4
Galway University Hospitals - Saolta University Health Care Group
Galway, Ireland, H91 YR71