Real-world Study on Safety, Effectiveness and Quality of Life of Trastuzumab Deruxtecan in Patients With Metastatic or Unresectable HER2-positive Breast Cancer: a French Ambispective Multicentre 2 Year-follow-up Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Percentage of patients with at least one Trastuzumab deruxtecan related Adverse Drug Reaction of interest
研究概览
简要总结
Collection of data in real life conditions on satefy, effectiveness and quality of life of trastuzumab deruxtecan in patients with metastatic or unresectable HER2-positive breast cancer.
详细描述
The present observational study aims to collect data on long-term safety of trastuzumab deruxtecan, with a primary endpoint on trastuzumab deruxtecan related adverse drug reactions (ADRs) of interest. Data on patient profile, treatment history (before, during and after trastuzumab deruxtecan administration), effectiveness and health-related quality of life will also be collected in a real-life setting, to confirm and complement data from clinical trials. Patients will be recruited whether they have started trastuzumab deruxtecan treatment or will start it at the time of inclusion, whether they were prescribed compassionate trastuzumab deruxtecan or marketed Enhertu®, in order to rapidly collect a large set of data.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female adult patient (age ≥ 18 years);
- •Unresectable or metastatic HER2+ breast cancer, previously treated with at least 2 lines of anti-HER2, and:
- •previously treated by compassionate trastuzumab deruxtecan (ATU group), or
- •previously treated or planned to be treated by trastuzumab deruxtecan (Enhertu®), upon the investigator's decision (Post-Marketing authorization group);
- •Patient who expresses non-opposition to participate in the study, or deceased patient who did not express his/her opposition to the use of his/her personal data while alive.
排除标准
- •Previous participation in an interventional clinical trial with trastuzumab deruxtecan
结局指标
主要结局
Percentage of patients with at least one Trastuzumab deruxtecan related Adverse Drug Reaction of interest
时间窗: 2 years following the start of administration of Trastuzumab deruxtecan
The primary endpoint is the percentage of patients with at least one Trastuzumab deruxtecan related Adverse Drug Reaction of interest
次要结局
未报告次要终点