NCT05399329已完成不适用
Retrospective, Multicenter, Observational Study to Evaluate Real-World Effectiveness of Palbociclib Plus Endocrine Therapy in Japanese Patients With HR+/HER2- Advanced Breast Cancer in First Line or Second Line Settings
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 693
- 试验地点
- 24
- 主要终点
- rePFS of palbociclib plus ET as second line treatment for HR+/HER2- ABC
研究概览
简要总结
This is a retrospective, multicenter, observational study in Japan by medical record review of advanced breast cancer (ABC) patients who have received palbociclib plus endocrine therapy (ET) as first line or second line setting. For the purposes of this study, analyses will be descriptive in nature. No formal hypothesis testing is planned.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of HR+/HER2- ABC
- •Age of 20 years or older at diagnosis of ABC
- •Patients that received palbociclib plus ET in the first line or second line
- •Patients who meet the criteria regarding the medical record below:
- •Patients with any medical records (regardless of palbociclib use) for more than 6 months from palbociclib initiation OR
- •Patients with any medical records for less than 6 months from palbociclib initiation AND who had specific events (death, disease progression, or treatment discontinuation of palbociclib due to adverse events) in the available records
排除标准
- •Patients who received chemotherapy as first line treatment.
- •Patients who have previously participated or are participating in any interventional clinical trials that include investigational or marketed products.
- •(Interventional clinical trials for early breast cancer and later line after palbociclib will be acceptable, Besides, patients participating in other investigator-initiated research or noninterventional studies can be included as long as their standard of care is not altered by the study.)
结局指标
主要结局
rePFS of palbociclib plus ET as second line treatment for HR+/HER2- ABC
时间窗: 15 December 2017 to 31 August 2023
Real-World Progression-Free Survival (rwPFS) of palbociclib plus ET as first line treatment for HR+/HER2- ABC
时间窗: 15 December 2017 to 31 August 2023
次要结局
- Landmark overall survival (OS) (defined from palbociclib initiation to death) of palbociclib plus ET as first line treatment for HR+/HER2- ABC(15 December 2017 to 31 August 2023)
- Time to treatment discontinuation (TTD) of palbociclib plus ET as first line or second line treatment for HR+/HER2- ABC(15 December 2017 to 31 August 2023)
- Time to chemotherapy (TTC: defined as the time from treatment initiation of first or second line for HR+/HER2- ABC to first use of chemotherapy)(15 December 2017 to 31 August 2023)
- Clinical characteristics of HR+/HER2- ABC patients who were treated with palbociclib plus ET in routine clinical practice in Japan(15 December 2017 to 31 August 2023)
- Real-world objective response rate (rwORR) of palbociclib plus ET as first line or second line treatment for HR+/HER2- ABC(15 December 2017 to 31 August 2023)
- Landmark OS (defined from palbociclib initiation to death)of palbociclib plus ET as second line treatment for HR+/HER2- ABC(15 December 2017 to 31 August 2023)
- Landmark OS (defined from treatment initiation of first line to death) when palbociclib plus ET were used as second line treatment for HR+/HER2- ABC(15 December 2017 to 31 August 2023)
- TTD of first subsequent treatment for HR+/HER2- ABC patients who were treated with palbociclib plus ET(15 December 2017 to 31 August 2023)
- Treatment patterns of palbociclib plus ET in routine clinical practice in Japan(15 December 2017 to 31 August 2023)
- Demographic of HR+/HER2- ABC patients who were treated with palbociclib plus ET in routine clinical practice in Japan(15 December 2017 to 31 August 2023)
研究者
研究点 (24)
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