Real-World Outcomes of Patients With HR-Positive HER2-Negative Metastatic Breast Cancer After Treatment With First-Line ET+CDK4/6i in the United States
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,415
- 试验地点
- 1
- 主要终点
- Real-world progression-free survival (rwPFS)
研究概览
简要总结
This study aims to assess the treatment patterns and real-world outcomes of HR+/HER- metastatic breast cancer patients who have progressed on 1L ET + CDK4/6i and started a second line (2L) treatment within a real-world cohort in the United States Flatiron Health Database.
详细描述
This analysis will assess real-world outcomes in HR+/HER2- mBC patients who initiated a subsequent line of therapy (LOT) (i.e., 2L) after progressing on 1L treatment with ET+CDK4/6i. This study will also characterize the treatment patterns, clinical characteristics, and outcomes in this patient population. No study drug was administered in this non-interventional study.
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
结局指标
主要结局
Real-world progression-free survival (rwPFS)
时间窗: Baseline up to end of observation period, approximately 7 years 9 months
Real-world progression-free survival (rwPFS) will be calculated as the time from the index treatment date to the date of the first documented rwP event occurring \>14 days after the index treatment date or date of death, whichever occurs first.
次要结局
- Real-world overall survival (rwOS)(Baseline up to end of observation period, approximately 7 years 9 months)
- Real-world time to discontinuation or death (rwTTD/D)(Baseline up to end of observation period, approximately 7 years 9 months)
- Real-world time to next treatment or death (rwTTNT/D)(Baseline up to end of observation period, approximately 7 years 9 months)