Title: Assessing benefit of no armpit node removal or radiation compared armpit node removal or radiation in patients with early stage of breast cancer whose arm pit nodes become cancer free after chemotherapy

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome <br/ ><br>•Arm lymphedema <br/ ><br>•Disease-Free Survival (DFS) <br/ ><br> <br/ ><br>Timepoint: Over 5 years follow up

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes <br/ ><br>•Recurrence free interval <br/ ><br>•Axillary recurrence free interval <br/ ><br>•Overall survivalTimepoint: Over 5 years follow up