NCT02305628已完成不适用
Post-Marketing Surveillance of Herceptin Subcutaneous in Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 23
- 主要终点
- Safety (composite outcome measure): Incidence of adverse events (AEs), serious adverse events (SAEs), adverse events of special interest, pregnancies, adverse drug reactions (ADRs); unexpected ADRs; expected ADRs
研究概览
简要总结
This is a phase IV, prospective, multicenter, observational study (regulatory post-marketing surveillance) in approximately 600 patients who are to receive Herceptin SC (trastuzumab, subcutaneous administration) per approved local labeling. Patients will be under observation according to standard of care in Korea.
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 administered Herceptin SC for the locally approved indications
排除标准
- 未提供
结局指标
主要结局
Safety (composite outcome measure): Incidence of adverse events (AEs), serious adverse events (SAEs), adverse events of special interest, pregnancies, adverse drug reactions (ADRs); unexpected ADRs; expected ADRs
时间窗: Up to 6 years
次要结局
- Efficacy: Overall response per Response Evaluation Criteria in Solid Tumors (RECIST)(Up to 6 years)
- Efficacy: Pathological Complete Response (pCR) in neoadjuvant early breast cancer (EBC)(Up to 6 years)
研究者
研究点 (23)
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