A Randomized Trial Comparing Sentinel Lymph Node Biopsy Vs no Axillary Surgical Staging in Patients With Small Breast Cancer and a Negative Preoperative Axillary Assessment (IEO S637/311)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,560
- 试验地点
- 30
- 主要终点
- Distant-disease free survival
研究概览
简要总结
The hypothesis of this trial are that:
- avoiding axillary surgery does not worsen the outcome of patients with small breast cancer the absence of the pathological information on the risk of recurrence given by nodal status is not worsening outcome of these patients
- pre-operative imaging of the axilla can identify patients with clinically relevant nodal burden.
The aims of this prospective randomized study are:
- to verify whether, in presence of a negative preoperative axillary assessment, SLN can be spared
- to verify whether, in presence of a negative preoperative axillary assessment, the decision on adjuvant medical treatment can be taken according only to the biology of the tumour without the prognostic information achieved by SLNB on the nodal status
- to verify whether, in presence of a negative preoperative axillary assessment, the patients' quality of life can be improved by a less invasive surgical procedure.
详细描述
Sentinel lymph node biopsy (SLNB) is the standard approach for axillary staging in patients with breast cancer worldwide. The evident trend of breast cancer treatment is going towards minimizing axillary surgery, even in presence of involvement of the sentinel lymph node (SLN). In fact, it is well known that removal of lymph nodes is performed with staging purposes and to improve regional control but not with curative intent. Recent data from a prospective randomized trial which compared axillary dissection vs. no further axillary surgery in presence of positive SLN did not show any difference in term of overall and disease-free survival. Moreover, to date the impact of the prognostic information of axillary lymph node status in the decision-making process is less important than in the past as the adjuvant treatment is more and more tailored on the biological features of the disease rather than on the risk of recurrence.
This is a prospective randomized controlled trial in which patients with small breast cancer (T<2 cm), with a negative preoperative assessment of the axilla (ultra-sound with FNAC in presence of doubtful findings) will be randomized into two treatment arms:
- SLNB ± axillary dissection
- No axillary surgical staging In the arm 1, no axillary dissection will be performed in case of either negative SLN or in presence of isolated tumour cells or micrometastases. SLNB will be completed by axillary dissection in presence of macrometastases diagnosed in the SLN.
The aims of this prospective randomized study are:
to verify whether, in presence of a negative preoperative axillary assessment, SLN can be spared to verify whether, in presence of a negative preoperative axillary assessment, the decision on adjuvant medical treatment can be taken according only to the biology of the tumour without the prognostic information achieved by SLNB on the nodal status to verify whether, in presence of a negative preoperative axillary assessment, the patients' quality of life can be improved by a less invasive surgical procedure.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •breast cancer <2 cm, and a clinically negative axilla
- •candidates to receive breast conserving surgery + radiotherapy
- •negative preoperative assessment of the axilla (ultra-sound with or without FNAC in case one doubtful node is found)
- •written informed consent must be signed and dated by the patient and the investigator prior to inclusion.
- •patients must be accessible for follow-up.
排除标准
- •synchronous distant metastases
- •previous malignancy
- •bilateral breast cancer
- •multicentric or multifocal breast cancer
- •previous primary systemic therapy
- •pregnancy or breastfeeding
- •pre-operative diagnosis (cytology or histology) of axillary lymph node metastases
- •pre-operative radiological evidence of multiple involved or suspicious nodes
- •patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study.
结局指标
主要结局
Distant-disease free survival
时间窗: 6 months
次要结局
- Cumulative incidence of axillary recurrences(6 months)
- Disease free survival (DFS)(6 months)
- Overall survival(6 months)
- Cumulative incidence of distant recurrences(6 months)