NCT05361655已完成不适用
Real-World Treatment Effectiveness of Palbociclib in Combination With an Aromatase Inhibitor as 1st Line Therapy in Metastatic Breast Cancer
适应症
干预措施
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
- 2,888
- 试验地点
- 1
- 主要终点
- Overall Survival (OS) in Postmenopausal Female or Male Participants With Metastatic Breast Cancer
研究概览
简要总结
A retrospective study of de-identified (to preserve patient privacy) patient information from the Flatiron Health Analytic Database to compare effectiveness (i.e., overall survival) of first line palbociclib + aromatase inhibitor (AI) versus AI alone treatment in postmenopausal women or men with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) metastatic breast cancer (MBC) in the United States clinical practices.
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
- •Confirmed HR+/HER2- status after MBC diagnosis.
- •Received palbociclib + AI or AI as first-line therapy
排除标准
- •Evidence of prior treatment with other CDK4/6I, AI, tamoxifen, raloxifene, toremifene, or Fulvestrant for MBC
- •First structured activity greater than 90 days after MBC diagnostic date
- •Treatment with a CDK4/6 inhibitor as part of a clinical trial
研究组 & 干预措施
Palbociclib + an aromatase inhibitor
Adult metastatic breast cancer patients who initiated Palbociclib + an aromatase inhibitor as first line therapy between Feb 3, 2015 to March 31, 2020 in the Flatiron Health Analytic Database.
干预措施: Palbociclib + an aromatase inhibitor (Drug)
Aromatase inhibitor
Adult metastatic breast cancer patients who initiated an aromatase inhibitor as first line therapy between Feb 3, 2015 to March 31, 2020 in the Flatiron Health Analytic Database.
干预措施: Aromatase inhibitor (Drug)
结局指标
主要结局
Overall Survival (OS) in Postmenopausal Female or Male Participants With Metastatic Breast Cancer
时间窗: From index date to death due to any cause or censoring date of 30-Sep-2020 (approximately up to 68 months)
OS was defined as the time from the index date (start of palbociclib + AI or AI alone) to death. Participants who did not die, were censored at the end of study date (30-Sep-2020). Kaplan-Meier method adjusted by stabilized inverse probability of treatment weighting (sIPTW) was used.
次要结局
- Number of Participants According to Real-World Tumor Responses (rwTR): Postmenopausal Female or in Male Participants With Metastatic Breast Cancer(From 30 days after index treatment initiation until CR, PR, SD or PD (approximately 67 months))
- Time to Dose Adjustment for Palbociclib- Palbociclib + Aromatase Inhibitor Arm Only(At index (anytime between 03-Feb-2015 to 30-Sep-2020, approximately up to 68 months))
- Duration of Treatment(From start of study treatment to end of treatment, start of subsequent line of therapy, or death from any cause, whichever occurred first (up to 68 months))
- Real-World Progression Free Survival (rwPFS) in Postmenopausal Female or in Male Participants With Metastatic Breast Cancer(From index date until disease progression or death due to any cause or censoring date (approximately up to 68 months))
- Real-World Response Rate (rwTR) in Postmenopausal Female or in Male Participants With Metastatic Breast Cancer(From 30 days after index treatment initiation until disease progression or death due to any cause or censoring date (approximately up to 67 months))
- Number of Participants According to Initial Dose of Palbociclib: Palbociclib + Aromatase Inhibitor Arm Only(At index (anytime between 03-Feb-2015 to 31-Mar-2020, approximately up to 62 months))
- Time to Next Line of Treatment(From start of study treatment to start of next line of therapy (up to 68 months))
- Real-World Progression Free Survival 2 (rwPFS2) in Postmenopausal Female or in Male Participants With Metastatic Breast Cancer(From start of study treatment until disease progression, or death from any cause following second line of therapy, whichever occurred first (approximately up to 68 months))
- Time to Subsequent Chemotherapy(From start of study treatment to administration of different chemotherapeutic agent (up to 68 months))
研究者
研究点 (1)
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