NCT02305641已完成不适用
Post-Marketing Surveillance of Kadcyla in Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 563
- 试验地点
- 38
- 主要终点
- Safety (composite outcome measure): Incidence of serious adverse events (SAEs), adverse drug reactions (ADRs); unexpected adverse events and ADRs; expected ADRs; non-serious ADRs
研究概览
简要总结
This is a phase IV, prospective, multicenter, non-interventional study (regulatory post-marketing surveillance) in approximately 500 patients who are to receive Kadcyla (trastuzumab emtansine). Patients administered Kadcyla infusion at physician's discretion will be registered for this surveillance in Korea. Patients will be asked to provide informed consent; data will be collected by electronic Case Report Forms for approximately 8 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
- •Patients who are administered with Kadcyla at physician's discretion will be registered for this study. The use of Kadcyla in the patients must fall into the approved indication in Korea.
排除标准
- •Patients not receiving treatment for breast cancer with Kadcyla according to standard of care and in line with the current summary of product characteristics (SPC)/local labeling.
- •A pediatric patient (age ≤18 years)
- •Hypersensitivity for Kadcyla or any ingredient in this product
结局指标
主要结局
Safety (composite outcome measure): Incidence of serious adverse events (SAEs), adverse drug reactions (ADRs); unexpected adverse events and ADRs; expected ADRs; non-serious ADRs
时间窗: Up to 8 years
次要结局
- Efficacy (composite outcome measure): Tumor response to Kadcyla treatment including complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD)(Up to 8 years)
研究者
研究点 (38)
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