Post-Marketing Surveillance of Perjeta in Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,130
- 试验地点
- 37
- 主要终点
- Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
This Phase IV, prospective, multicenter, non-interventional study (regulatory post-marketing surveillance) will evaluate the safety of pertuzumab in approximately 1000 participants with metastatic or locally unresectable recurrent breast cancer who have never received chemotherapy or anti-human epidermal growth factor receptor 2 (HER2) therapy for their metastatic disease with HER2 positivity in Korea. Participants who are administered with pertuzumab according to medical opinions of the doctor in charge of surveillance will be registered for this study and treated with pertuzumab under the approval conditions of the product 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
- •Participants with metastatic or locally unresectable recurrent breast cancer who have never received chemotherapy or anti-HER2 therapy for metastatic disease with HER2 positivity
- •HER2-positive, locally advanced, inflammatory, or early stage breast cancer (greater than [>]2 centimeters [cm] in diameter) participants who have never received chemotherapy and surgery for breast cancer
排除标准
- •Hypersensitivity for pertuzumab (Perjeta) or any of its excipients
- •Contraindications to Perjeta according to SmPC
- •Pregnancy and lactation
研究组 & 干预措施
Pertuzumab
Participants for whom the treating physician has decided to administer pertuzumab according to standard of care and in line with the current summary of product characteristics (SmPC)/local labeling, will be observed.
干预措施: Pertuzumab (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Baseline up to approximately 6 years
次要结局
- Percentage of Participants With Overall Response as Determined Using Response Evaluation Criteria in Solid Tumors (RECIST)(Baseline until disease progression or death, whichever occurs earlier (assessed up to approximately 6 years))