Comparative Assessment of Overall Survival in Medicare Patients With HR+/HER2- Metastatic Breast Cancer Treated With Palbociclib in Combination With Aromatase Inhibitor (AI vs. AI Alone)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 779
- 试验地点
- 1
- 主要终点
- Overall Survival According to Unadjusted Analysis
研究概览
简要总结
A retrospective study of de-identified (to preserve patient privacy) patient information from the SEER-Medicare Database to compare overall survival of first line palbociclib + aromatase inhibitor (AI) therapy versus AI therapy alone treatment in women or men aged 65 and older with newly diagnosed hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) metastatic breast cancer (MBC) in the United States
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •De novo metastatic (stage IV) disease at initial breast cancer diagnosis during 2015-2019
- •HR+/HER2- molecular subtype at diagnosis
- •Initiated 1L systemic therapy with palbociclib + AI or AI alone
排除标准
- •Patients will be excluded if their metastatic breast cancer diagnosis was first recorded in a death certificate or at the time of autopsy.
研究组 & 干预措施
Palbociclib + AI
Adult metastatic breast cancer patients who initiated Palbociclib + an aromatase inhibitor as first line therapy in SEER-Medicare
干预措施: Aromatase Inhibitor (Drug)
Palbociclib + AI
Adult metastatic breast cancer patients who initiated Palbociclib + an aromatase inhibitor as first line therapy in SEER-Medicare
干预措施: Palbociclib (Drug)
AI alone
Adult metastatic breast cancer patients who initiated an aromatase inhibitor (alone) as first line therapy
干预措施: Aromatase Inhibitor (Drug)
结局指标
主要结局
Overall Survival According to Unadjusted Analysis
时间窗: From index date to death (approximately 69.9 months); retrospective data evaluated in 4 months (approximately) of this study
Overall survival was defined as time in months from the study index date to all cause death. Study index date in this outcome measure was the date of first line of treatment initiation with palbociclib + AI or AI alone after the de novo mBC diagnosis. De novo mBC referred to breast cancer that physician diagnosed for the first time after it had already spread outside of the breast to distant parts of the body. Unadjusted analysis: analysis not considering any covariates, specifically potential differences in baseline characteristics that could confound the association between treatment and survival. Overall survival was assessed using Kaplan-Meier analysis.
Overall Survival According to Stabilized Inverse Probability of Treatment Weighted (sIPTW) Analysis
时间窗: From index date to death (approximately 69.9 months); retrospective data evaluated in 4 months (approximately) of this study
Overall survival was defined as time in months from the study index date to all cause death. Study index date in this outcome measure was the date of first line of treatment initiation with palbociclib + AI or AI alone after the de novo mBC diagnosis. De novo mBC referred to breast cancer that physician diagnosed for the first time after it had already spread outside of the breast to distant parts of the body. sIPTW analysis: stabilized inverse probability treatment weighting. This is a statistical method that reweights participants to create groups with similar baseline characteristics. The analysis therefore adjusts for differences in baseline characteristics that could confound the association between treatment and survival. Overall survival was assessed using Kaplan-Meier analysis.
次要结局
未报告次要终点