A PROSPECTIVE, SINGLE-ARM, OPEN-LABEL, NON-INTERVENTIONAL, MULTI-CENTRE, POST MARKETING SURVEILLANCE (PMS) STUDY OF TALZENNA(REGISTERED)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Pfizer
- 入组人数
- 600
- 主要终点
- Incidence of adverse events categorized according to physical organ and disease/symptom
研究概览
简要总结
Talzenna will be approved for the treatment of gBRCA advanced breast cancer in Korea. In accordance with the Standards for Re-examination of New Drug, it is required to conduct a PMS. Post marketing surveillance is required to determine any problems or questions associated with Talzenna after marketing in Korea, with regard to the following clauses under conditions of general clinical practice. Therefore, through this study, effectiveness and safety of Talzenna will be observed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient scheduled to start treatment with Talzenna® based on the clinical judgment of their treating physician as specified in the Korean-Prescribing information (local label)
- •Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
排除标准
- •Patients with known hypersensitivity to Talzenna®, or to any of the excipients.
- •Breastfeeding
- •Any patients (or a legally acceptable representative) who does not agree that Pfizer and companies working with Pfizer use his/her information.
研究组 & 干预措施
Talzenna treated group
Talzenna treated gBRCA Breast cancer patients in the real world setting in Korea
干预措施: Talzenna (Drug)
结局指标
主要结局
Incidence of adverse events categorized according to physical organ and disease/symptom
时间窗: From date of randomization until the 28 calendar days following the last administration of a drug under study
It is non-interventional, observational study in the real world setting. Adverse events will be captured in the real world clinical practice.
次要结局
- Overal response (Effectiveness outcome) by Response Evaluation Criteria In Solid Tumors (RECIST) critera(through study completion, an expected average of 8 months)