NCT05621564招募中不适用
The Effect of Pre-operative Therapy on Response and Survival in Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 6,032
- 试验地点
- 1
- 主要终点
- Pathologic Complete Response
研究概览
简要总结
This is a prospective and retrospective study to evaluate the effect of pre-operative therapy on response and survival, and compare the difference in response and survival by pre-operative regimen or by patient's clinicopathological characteristic in early or advanced breast cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Female, Aged ≥18 years
- •Histologically confirmed primary breast cancer
- •Plan to receive pre-operative therapy
- •Adequate organ function
排除标准
- •History of neurological or psychological disease, including epilepsy or dementia
- •Not suitable to participate in this study judged by investigators
研究组 & 干预措施
advanced breast cancer
no requirements for therapy
干预措施: pre-operative therapy (Drug)
early breast cancer
no requirements for therapy
干预措施: pre-operative therapy (Drug)
结局指标
主要结局
Pathologic Complete Response
时间窗: at surgery
ypT0 ypN0, ypT0/is ypN0
次要结局
- Disease-free Survival(From surgery until time of event up to 8 years)
- Objective response rate(from the start of pre-operative treatment until the completion of surgery up to 6 months)
研究者
Wenjin Yin
Deputy Chief of Breast Surgery Department
RenJi Hospital
研究点 (1)
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