Axillary Management in Breast Cancer Patients with Needle Biopsy Proven Nodal Metastases After Neoadjuvant Chemotherapy

Launched by UNIVERSITY HOSPITALS OF DERBY AND BURTON NHS FOUNDATION TRUST · Sep 27, 2019

Keywords

ClinConnect Summary

This clinical trial is looking at a new approach for treating early-stage breast cancer patients who have cancer that has spread to the lymph nodes. The researchers want to find out if it's safe to skip additional axillary treatments (like surgery or radiation) for these patients if tests show there is no remaining cancer in the lymph nodes after they have received chemotherapy. The goal is to see if avoiding these treatments can still keep patients healthy and reduce their risk of developing swelling in the arm, known as lymphedema, over the next five years.

To be eligible for this trial, participants should have been diagnosed with a specific type of breast cancer and have positive lymph node biopsy results. They should have undergone standard chemotherapy and then had a follow-up procedure to check for cancer in the lymph nodes. Key requirements include having no remaining cancer in the lymph nodes after treatment and having a certain number of lymph nodes removed during testing. This trial is currently recruiting participants of all genders aged 65 to 74. If you join the study, you will be closely monitored to see how well this approach works and to ensure your safety throughout the process.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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:
• • 1. involved node was marked and removed during SNB; and
• • 2. 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 Criteria:
• • 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