Health Condition 1: C509- Malignant neoplasm of breast of unspecified site Health Condition 2: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: No further axillary treatment within 6 months of surgery: No further axillary treatment (axillary radiotherapy [ART] or axillary clearance [ANC]), after neoadjuvant chemotherapy and sur
Sponsors
Dr Brijesh Kumar Singh
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age = 18 years 2. Female 3.Disease stage: cT1-3N1M0 at diagnosis (prior to NACT) as per AJCC 8th edition 4.Patients with confirmed metastasis on FNA or core biopsy in the axillary node at presentation 5.Estrogen receptor and HER2 status evaluated on primary tumour 6.Received standard NACT as per local guidelines 7.Axilla imaging to assess response to NACT (as per local guidelines) 8.Undergo dual tracer sentinel node biopsy (SNB) after NACT and at least 3 nodes removed in total (sentinel nodes and marked node). ?If a single tracer is used, the patient will be eligible if the involved node is marked before or during NACT, and the marked node and at least 3 nodes (including the marked node) are removed during sentinel node biopsy. ?If axillary node sampling is performed following failed localization of sentinel nodes, the patient will be eligible if at least 3 nodes are removed (including the marked node). ?If node is not marked, or marked node is not removed, the patient will be eligible 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 if: a) involved node was marked and removed during SNB; and b) removed marked node shows evidence of downstaging on histology e.g., fibrosis or scarring. •No evidence of nodal metastases posts NACT (isolated tumour cells, micro or macro metastasis)
Exclusion criteria
Exclusion criteria: 1.Bilateral synchronous invasive breast cancer 2.Sentinel node biopsy prior to NACT 3.Previous axillary nodal surgery on the same body side as the scheduled targeted sampling 4.Any previous cancer within last 5 years or concomitant malignancy except contra- or ipsilateral in situ breast cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome •Arm lymphedema •Disease-Free Survival (DFS) Timepoint: Over 5 years follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes •Recurrence free interval •Axillary recurrence free interval •Overall survivalTimepoint: Over 5 years follow up | — |
Countries
India
Contacts
Public ContactDr Brijesh Kumar Singh
All India Institute of Medical Sciences
Outcome results
None listed