NCT06784921招募中不适用
Real-World Patient Characteristics, Treatment Patterns, and Outcomes for Patients With HER2 Negative Metastatic Breast Cancer Treated With Sacituzumab Govitecan: A Retrospective Trial in China（SACIT-OUT）
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
To investigate the real-world efficacy and safety of Sacituzumab govitecan for HER2 negative metastatic breast cancer patients in China.
详细描述
This study will conduct a multicenter, open, prospective clinical trial to investigate the real-world efficacy and safety of Sacituzumab govitecan for HER2 negative metastatic breast cancer patients in China.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Local recurrent or metastatic breast cancer suitable for chemotherapy, confirmed histologically.
- •HER2-negative breast cancer(according to 2018 ASCO/CAP HER2 test guideline). 18-75 years old. ECOG PS 0～
- •life expectancy is not less than 12 weeks. at least one measurable lesion according to RECIST 1.
- •received at least two cycles of SG. Signed informed
排除标准
- •Patients who did not receive sacituzumab govitecan treatment for two or more cycles Other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, have been diagnosed in the past five years.
- •Female patients during pregnancy and lactation, fertile women with positive baseline pregnancy tests or women of childbearing age who are unwilling to take effective contraceptive measures throughout the trial History of neurological or psychiatric disorders Researchers believe that patients are not suitable for any other situation in this study.
结局指标
主要结局
PFS
时间窗: from enrollment to progression or death (for any reason),assessed up to 100 months
Progression-Free Survival
次要结局
- Objective Response Rate(from enrollment to progression or death (for any reason), assessed up to 100 months)
- DoR(The first evaluation of CR or PR to progression or death (for any reason),assessed up to 100 months)
- OS(from enrollment to death (for any reason).assessed up to 100 months)
研究者
Wang Xiaojia
MD
Zhejiang Cancer Hospital
研究点 (1)
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