NCT01152606已完成不适用
An Observational Study of Cardiac Events in Patients With HER2 Positive Early Breast Cancer Treated With Herceptin
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,942
- 试验地点
- 205
- 主要终点
- Incidence of symptomatic congestive heart failure\n(CHF) using New York Heart Association class II, III and IV, and cardiac death
研究概览
简要总结
This is a single cohort observational safety study. All patients will be treated and monitored according to the local clinical practice. No additional procedures/patient visits in comparison with the usual clinical practice are planned for the study. Data will be collected from centre's medical records for up to 5 years or death.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients who are considered candidates to receive Herceptin for this indication
排除标准
- •Patients for whom Herceptin is contraindicated
研究组 & 干预措施
Cohort
干预措施: trastuzumab [Herceptin] (Drug)
结局指标
主要结局
Incidence of symptomatic congestive heart failure\n(CHF) using New York Heart Association class II, III and IV, and cardiac death
时间窗: On treatment and up to 5 years follow-up
次要结局
- Time to onset and the time to recovery of symptomatic congestive heart failure(On treatment and up to 5 years follow-up)
- Incidence of asymptomatic cardiac failure and other significant cardiac conditions(On treatment and up to 5 years follow-up)
研究者
研究点 (205)
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