Sentinel Lymph Node Biopsy in Patients With Breast Cancer After Neoadjuvant Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 4
- 主要终点
- Clear indications for SLNB or axillary dissection
研究概览
简要总结
The aim of this study is to create clear indications for Sentinel Lymph Node Biopsy (SLNB) or Axillary Dissection (AD) in women with breast carcinoma after neoadjuvant therapy by studying the false negative rate of SLNB.
详细描述
The main object of the study is to evaluate, whether sentinel lymph node biopsy (SLNB) at women with breast cancer after neoadjuvant therapy is a method with a high false-negative rate. Patients will be classified into groups according to histological findings during SLNB, clinical and ultrasonography (USG) findings in the axilla. The aim of this study is to create clear indications for SLNB or axillary dissection (AD). In case of extension of SLNB indications, there will be a decrease in morbidity after surgical therapy when compared to AD, which will mean a profit for the patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
No roles in the study will be marked.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •diagnosis of breast carcinoma confirmed by biopsy
- •neoadjuvant therapy
- •examination of axillary lymph nodes clinically and by ultrasound
- •surgical therapy after neoadjuvant therapy
排除标准
- •inflammatory breast carcinoma
- •incomplete neoadjuvant therapy
- •previous sentinel lymph node biopsy performed on the same side of the body
- •disagreement with participation in the study
- •other malignities influencing the treatment of breast carcinoma
- •distant metastases
结局指标
主要结局
Clear indications for SLNB or axillary dissection
时间窗: 24 months
Clear indications for SLNB or axillary dissection (AD) in women with breast carcinoma after neoadjuvant therapy using false-negativity rate of SLNB. False-negativity rate of SLNB under 10% is acceptable for avoiding AD.
次要结局
- Morbidity(24 months)
- Progression-free Survival(24 months)
- Changes in the Quality of Life(24 months)
- Disease-free Survival(24 months)
- Overall Survival(24 months)