CTRI/2023/09/057446尚未招募3 期
Further Axillary Treatment vs No Treatment in cT1-3N1M0 Breast Cancer Patients with Node Negativity after Neoadjuvant Chemotherapy: A Randomized Controlled Trial - Nil
Dr Brijesh Kumar Singh0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Age = 18 years
- •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)
排除标准
- •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
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