NCT04993625进行中（未招募）不适用
Selective Avoidanve of Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy In HER-2 Positive/Triple Negative Breast Cancer Patients With Excellent Radiologic Response to the Breast and Axilla, Prospective, Multi-center, Single-arm Study
Jeong Eon Lee1 个研究点 分布在 1 个国家目标入组 178 人开始时间: 2021年9月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- 5-year recurrence free survival
研究概览
简要总结
The aims of this study is to evaluate 5 year recurrence free survival when omit sentinel lymph node biopsy after neoadjuvant chemotherapy in triple negative or HER-2 positive breast cancer patients when physical examination expected complete remission. And radiological expected Tumor size ≤ 2cm or non-mass enhancement ≤ 4cm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
5-year recurrence free survival
时间窗: 5-year after last patient enrollment
The aims of this study is to evaluate 5 year recurrence free survival when omit sentinel lymph node biopsy after neoadjuvant chemotherapy in triple negative or HER-2 positive breast cancer patients when expected complete remission.
次要结局
- IBTR(5-year after last patient enrollment)
- LRFS(5-year after last patient enrollment)
- OS(5-year after last patient enrollment)
- toxicity rate(5-year after last patient enrollment)
- Adverse Event(5-year after last patient enrollment)
- CSS(5-year after last patient enrollment)
- IARI(5-year after last patient enrollment)
- EORTC QLQ(5-year after last patient enrollment)
研究者
Jeong Eon Lee
Samsung Medical Center
Samsung Medical Center
研究点 (1)
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