NCT01991340已完成不适用
H.E.R.O.S. Study: Observational Study to Assess the Cardiac Safety Profile of Trastuzumab in Patients With HER2-positive Breast Cancer.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 657
- 主要终点
- Safety: Incidence of adverse events
研究概览
简要总结
This observational study will assess the safety of Herceptin (trastuzumab) in patients with HER2-positive breast cancer in routine clinical practice. Eligible patients will be followed for up to 4 years.
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
- •Adult patients, >/= 18 years of age
- •Histologically confirmed HER2-positive breast cancer
- •Eligible to receive Herceptin as per Summary of Product Characteristics
排除标准
- •Contra-indications according to Summary of Product Characteristics
结局指标
主要结局
Safety: Incidence of adverse events
时间窗: up to approximately 4.5 years
次要结局
- Incidence of symptomatic congestive heart failure (NYHA class II, III and IV)(up to approximately 4.5 years)
- Incidence of asymptomatic LVEF decline(up to approximately 4.5 years)
- Frequency of treatment discontinuations/interruptions(up to approximately 4.5 years)
研究者
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