ISRCTN36585784进行中（未招募）未知
ATNEC - Axillary management in T1-3N1M0 breast cancer patients with needle biopsy-proven nodal metastases at presentation after neoadjuvant chemotherapy
niversity Hospitals of Derby and Burton NHS Foundation Trust0 个研究点目标入组 1,900 人开始时间: 2020年12月2日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,900
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
- 性别
- All
入选标准
- •Current inclusion criteria as of 05/02/2024:
- •1. Age =18 years
- •2. Male or female
- •3. cT1-3N1M0 breast cancer at diagnosis (prior to NACT) as per AJCC 8th edition
- •3.2 Patients with occult primary invasive breast cancer (no identifiable invasive cancer in the breast) with FNA or core biopsy provide nodal metastases are also eligible for the study.
- •4. FNA or core biopsy confirmed axillary nodal metastases at presentation
- •5. Oestrogen receptor and HER2 status evaluated on primary tumour
- •6. Received standard NACT as per local guidelines (Patients undergoing neoadjuvant endocrine therapy as part of another clinical trial are eligible)
- •7. Imaging of the axilla, as required, to assess response to NACT (per local guidelines)
- •8. Undergo a dual tracer sentinel node biopsy (SNB) after NACT with at least 3 nodes removed in total (sentinel nodes and marked node).
- •8.1 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.
- •8.2 If the node is not marked, or marked node is not removed: the patient is eligible only if the histology report shows evidence of downstaging with complete pathological response e.g. fibrosis or scarring in at least one node and at least 3 nodes removed.
- •8.3 If fewer than 3 nodes are found on histology: the patient is eligible only if BOTH points a) and b), below, are met:
- •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.
- •8.4 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).
- •9. No evidence of nodal metastases post NACT (isolated tumour cells, micro or macrometastasis)
- •Previous inclusion criteria as of 19/07/2023 to 05/02/2024:
- •1. Age =18 years
- •2. Male or female
- •3. cT1-3N1M0 breast cancer at diagnosis (prior to NACT) as per AJCC 8th edition
- •4. FNA or core biopsy confirmed axillary nodal metastases at presentation
- •5. Oestrogen receptor, progesterone receptor and HER2 status evaluated on primary tumour
- •6. Received standard NACT as per local guidelines (Patients undergoing neoadjuvant endocrine therapy as part of another clinical trial are eligible)
- •7. Imaging of the axilla to assess response to NACT (as per local guidelines)
- •8. Undergo dual tracer sentinel node biopsy after NACT and at least 3 nodes removed (sentinel nodes and marked node).
- •8.1 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.
- •8.2 If axillary node sampling is performed following failed localisation of sentinel nodes, patient will be eligible if at least three nodes removed (including the marked node).
- •8.3 If node is not marked, or marked node is not removed, the patient will be eligible if the histology report shows evidence of downstaging with complete pathological response e.g. fibrosis or scarring in at least one node and at least 3 nodes removed.
- •8.4 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.
- •9. No evidence of nodal metastases
排除标准
- •Current exclusion criteria as of 19/07/2023:
- •1. Bilateral synchronous invasive breast cancer
- •2. Sentinel node biopsy prior to NACT
- •3. Previous axillary surgery on the same body side as the scheduled targeted sampling
- •4. Any previous cancer within 5 years or concomitant malignancy except:
- •4.1. Basal or squamous cell carcinoma of the skin
- •4.2. In situ carcinoma of the cervix
- •4.3. In situ melanoma
- •4.4. Contra- or ipsilateral in situ breast cancer
- •Previous exclusion criteria:
- •1. Bilateral invasive breast cancer
- •2. Sentinel node biopsy prior to NACT
- •3. Marked node not removed except where the node/s removed show evidence of down-staging with complete pathological response e.g. fibrosis or scarring
- •4. Previous axillary surgery on the same body side as the scheduled targeted sampling
- •5. Any previous cancer within 5 years or concomitant malignancy except:
- •5.1. Basal or squamous cell carcinoma of the skin
- •5.2. In situ carcinoma of the cervix
- •5.3. In situ melanoma
- •5.4. Contra- or ipsilateral in situ breast cancer
研究者
相似试验
招募中
不适用
Axillary Management in Breast Cancer Patients With Needle Biopsy Proven Nodal Metastases After Neoadjuvant ChemotherapySentinel Lymph NodeNeoplasm, BreastBreast CancerNCT04109079University Hospitals of Derby and Burton NHS Foundation Trust1,900
尚未招募
不适用
Breast Tuberculosis symptoms and its managementCTRI/2018/10/015966khaja bandanawaz institute of medical sciences
尚未招募
3 期
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 chemotherapyCTRI/2023/09/057446Dr Brijesh Kumar Singh
已完成
不适用
Breast conserving therapy using Accelerated Partial Breast Irradiation (APBI) in elderly patients: a feasibility studymammacarcinoom1000629110006295Breast cancerNL-OMON45136Haaglanden Medisch Centrum509
招募中
不适用
Observational study of axilla treatment for breast cancer patients with micrometastases or 1 to 3-positive macrometastases in sentinel lymph nodesBreast cancerJPRN-UMIN000011782Japanese Society for Sentinel Node Navigation Surgery250