ATNEC - Axillary Management in T1-3N1M0 Breast Cancer Patients With Needle Biopsy Proven Nodal Metastases at Presentation After Neoadjuvant Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,900
- 试验地点
- 187
- 主要终点
- Disease free survival (DFS)
研究概览
简要总结
The aim of this study is to assess whether, omitting further axillary treatment (ALND and ART) for patients with early stage breast cancer and axillary nodal metastases on needle biopsy, who after NACT have no residual cancer in the lymph nodes on sentinel node biopsy, is non-inferior to axillary treatment in terms of disease free survival (DFS) and results in reduced risk of lymphoedema at 5 years.
详细描述
Background: The presence of cancer in the axillary lymph nodes on needle biopsy in patients with early stage breast cancer before neoadjuvant chemotherapy (NACT) has been the determinant of the need for axillary treatment (in the form of axillary lymph node dissection (ALND) or axillary radiotherapy (ART)) after completion of NACT. Treatment to the axilla damages lymphatic drainage from the arm and patients can subsequently develop lymphoedema, restricted shoulder movement, pain, numbness, and other sensory problems. As more effective chemotherapy is now available that results in complete eradication of cancer in the axilla in around 40 to 70% of patients, extensive axillary treatment might no longer be necessary in patients with no evidence of residual nodal disease.
Aim: To assess whether, omitting further axillary treatment (ALND and ART) for patients with early stage breast cancer and axillary nodal metastases on needle biopsy, who after NACT have no residual cancer in the lymph nodes on sentinel node biopsy, is non-inferior to axillary treatment in terms of disease free survival (DFS) and results in reduced risk of lymphoedema at 5 years.
Methods:
Study design: A pragmatic, phase 3, open, randomised, multicentre trial and embedded economic evaluation in which participants will be randomised in a 1:1 ratio.
Study population: T1-3N1M0 breast cancer patients aged 18 years or older, with needle biopsy proven nodal metastases, who after NACT have no residual cancer in the lymph nodes on dual tracer sentinel node biopsy and removal of at least 3 lymph nodes (sentinel nodes and marked involved node).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •involved node was marked and removed during SNB; and
- •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.
排除标准
- •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
结局指标
主要结局
Disease free survival (DFS)
时间窗: 5 years
DFS calculated as the time from randomisation until the date of first event of either a loco-regional invasive breast cancer relapse, distant relapse, ipsilateral or contralateral new invasive primary breast cancer or death by any cause or the censor date.
Patient reported lymphoedema
时间窗: 5 years
Lymphoedema is self-reported based on two items from the validated Lymphoedema and Breast Cancer Questionnaire (arm "swelling now" and arm "heaviness in the past year"). Lymphoedema is defined as 'yes' to both questions.
次要结局
- Overall survival(5 years)
- Axillary recurrence free interval(5 years)
- Health related quality of life: EQ-5D-5L(5 years)
- Distant metastasis(5 years)
- Non-breast cancer(5 years)
- Local (breast or chest wall) recurrence(5 years)
- Arm function(5 years)
- Regional (nodal) recurrence(5 years)
- Contralateral breast cancer(5 years)
研究者
Dr Amit Goyal
Consultant Oncoplastic Breast Surgeon & Associate Professor
University Hospitals of Derby and Burton NHS Foundation Trust