IS SENTINEL LYMPH NODE BIOPSY WITH RADIOTHERAPY ALONE WITHOUT AXILLARY LYMPH NODE DISSECTION SAFE FOLLOWING NEOADJUVANT CHEMOTHERAPY IN INITIALLY CLINICALLY AXILLA POSITIVE PATIENTS: NEOSENTITURK-TRIAL/MF-18-03
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 3
- 主要终点
- Local recurrence free survival
研究概览
简要总结
Omitting axilary lymph node dissection (ALND) following SLNB with residual cancer in patients with locally advanced disease after neoadjuvan chemotherapy (NAC) is still controversial. In this study, the investigators evaluated factors affecting local recurrence and outcome in patients with locally advanced breast cancer (LABC), who underwent sentinel lymph node (SLN) with or without ALND after NAC.
详细描述
All patients with clinically positive axilla will undergo neoadjuvant chemotherapy. Axillary fine needle aspiration biopsy or Trucut biopsy is mandatory.
All patients with clinically node negativity (physical exam, USG, and/or MRI, PET-CT) after Neoadjuvant Chemotherapy (NAC) will be considered for SLNB with any technique (blue dye alone, radionuclide alone or both combined) and any breast surgery (mastectomy or breast conservation). PET-CT and MRI are not mandatory. PE and USG and/or MRI are preferred. At least, 2 sentinel lymph nodes will be obtained. Intraoperative evaluation of SLNs is recommended.
All patients with clinally-negative axilla and underwent SLNB will be included into the study:
- SLNB (-) & RT
- SLNB (+) & RT
- SLNB (+) & ALND & RT Radiotherapy details will be announced as supplementary
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •T0-4, N1-3, M0
排除标准
- •Inflammatory breast cancer, pregnant patients Patients with metastatic disease
结局指标
主要结局
Local recurrence free survival
时间窗: January 2023
Breast and axillary recurrence rates
次要结局
- Disease free survival(January 2023)
- Overall survival(January 2023)