Palbociclib Treatment Patterns and Outcomes in HR+/HER2- MBC: Flatiron Database Analysis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Pfizer
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
Palbociclib, the first oral CDK4/6 inhibitor, is an approved medicine indicated for the treatment of a kind of advanced/metastatic breast cancer (MBC), called hormone receptors positive (HR+)/ Human epidermal growth factor receptor 2 negative (HER2-) disease. Palbociclib is given orally in combination with hormonal therapies.
The purpose of this study is to better understand how Palbociclib combination is used in real-life conditions and its clinical impact compared with hormonal therapy. The study will also evaluate how long patients take the different CDK 4/6 inhibitor drugs and whether using those drugs impacts the use of chemotherapy later.
Male and female patients aged 18 years old or more presenting the following conditions will be selected for the study:
- HR+/HER2- MBC
- First treatment with Palbociclib, hormonal therapy, or other CDK4/6 inhibitors after MBC diagnosis The study will use data without personal identity, which were obtained from medical records in routine clinical practice.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Palbociclib + aromatase inhibitor (AI)
Oral palbociclib + AI combination treatment regimen as decided by physician
干预措施: Palbociclib (Drug)
Palbociclib + aromatase inhibitor (AI)
Oral palbociclib + AI combination treatment regimen as decided by physician
干预措施: Aromatase inhibitor (Drug)
Aromatase inhibitor (AI)
Oral AI treatment regimen as decided by physician
干预措施: Aromatase inhibitor (Drug)
Abemaciclib plus aromatase inhibitor (AI)
Oral abemaciclib plus AI treatment regimen as decided by physician
干预措施: Palbociclib (Drug)
Abemaciclib plus aromatase inhibitor (AI)
Oral abemaciclib plus AI treatment regimen as decided by physician
干预措施: Aromatase inhibitor (Drug)
Abemaciclib plus aromatase inhibitor (AI)
Oral abemaciclib plus AI treatment regimen as decided by physician
干预措施: Abemaciclib (Drug)
Ribociclib plus aromatase inhibitor (AI)
Oral ribociclib plus AI as decided by physician
干预措施: Aromatase inhibitor (Drug)
Ribociclib plus aromatase inhibitor (AI)
Oral ribociclib plus AI as decided by physician
干预措施: Ribociclib (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: From start of index line of therapy to death, February 2015 - December 2022 or data cutoff
次要结局
- Real Progression Free Survival (rwPFS)(From start of index line of therapy to death or disease progression, February 2015 - December 2022 or data cutoff)
- Real-World Tumor Response (rwTR)(From start of index treatment to tumor response, February 2015 - December 2022 or data cutoff)
- Duration of treatment(from index treatment initiation to end of the treatment, February 2015 - December 2022 or data cutoff)
- Time to chemotherapy(from index treatment initiation to subsequent chemotherapy, February 2015 - December 2022 or data cutoff)
- Progression Free Survival 2(from start of index treatment to disease progression on the 2nd line of therapy or death, February 2015 - December 2022 or data cutoff)