A Randomized Trial of Sentinel Lymph Node Biopsy vs Radiotherapy Alone After Neoadjuvant Chemotherapy in Patients Undergoing Breast Conserving Surgery With cT1-3N1, ycN0 Breast Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,380
- 主要终点
- Disease-free survival
研究概览
简要总结
The OBSERB study is a multi-center, non-blinded, pragmatic, parallel, randomized controlled trial in which patients with cT1-3N1 and ycN0 breast cancer.
详细描述
The OBSERB study aims to compare the oncologic outcomes of radiotherapy without sentinel lymph node biopsy versus sentinel lymph node biopsy for the management of breast cancer which showed the cN1 was conversed as ycN0 after neoadjuvant chemotherapy.
To verify whether, the radiotherapy without SLN can be applied, when the cN1 was conversed as ycN0 after neoadjuvant chemotherapy.
To verify whether, the additional treatment decision can be established based on only the biology of primary tumor without the pathologic information of axillary lymph nodes To verify whether, the patients' quality of life can be improved by a less invasive surgical procedure, when the cN1 was conversed as ycN0 after neoadjuvant chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women aged > 20 years
- •cT1-3N1M0, primary invasive
- •initially confirmed ALN by fine needle aspiration cytology before neoadjuvant chemotherapy
- •completion of neoadjuvant chemotherapy
- •tumors negative for LN metastasis confirmed by imaging after neoadjuvant chemotherapy
排除标准
- •synchronous distant metastases
- •previous other malignancy
- •bilateral breast cancer
- •previous primary systemic therapy
- •pregnancy or breastfeeding
- •pre-operative radiological evidence of multiple involved or suspicious axillary nodes
- •patient 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
Disease-free survival
时间窗: 5 years
Disease free survival including breast, axilla and other organs from medical record
次要结局
- Overall survival(5 years)
- Local recurrence(5 years)
- distant free survival(5 years)
- Axillary recurrence(5 years)
- distant recurrence(5 years)
研究者
JeeYeon Lee
Clinical professor
Kyungpook National University Chilgok Hospital