NCT07281001招募中不适用
A Study to Assess the Efficiency of Trastuzumab Deruxtecan in Russian Breast Cancer Patients
Blokhin's Russian Cancer Research Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年12月1日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
This multi-center observational retrospective study will collect real-world clinical data from eligible patients with unresectable or metastatic HER2+ breast cancer who have received one or more cycles Trastuzumab Deruxtecan in Russian Federation
详细描述
This multi-center observational retrospective study will collect real-world clinical data from eligible patients with unresectable or metastatic HER2+ breast cancer who have received one or more cycles Trastuzumab Deruxtecan in Russian Federation
The aim of this trial is to explore the real-world effectiveness T-Dxd and potential predictors in Russian metastatic breast cancer patients
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged over 18 years old.
- •Metastatic breast cancer included unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer.
- •Patients has received Trastuzumab Deruxtecan
- •Available medical history.
排除标准
- •Incomplete medical history.
- •Pregnancy or breast-breeding
研究组 & 干预措施
Patients with unresectable or metastatic HER2+ BC who have received one or more cycles T-DXd
Experimental
干预措施: T-DXd 5.4 mg/kg, IVD, 1 cycle every 21 days. (Drug)
结局指标
主要结局
PFS
时间窗: 6 weeks
progression-free survival
次要结局
- ORR(6 weeks)
- CBR(6 weeks)
- OS(6 weeks)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(6 weeks)
研究者
研究点 (1)
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