Eribulin [Halaven] Use For the Treatment of Advanced Breast Cancer: Observational Retrospective Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 17
- 主要终点
- Clinical benefit rate
研究概览
简要总结
The purpose of this study was to evaluate the efficacy and safety of eribulin in standard clinical practice in patients with locally recurrent or metastatic advanced breast cancer.
详细描述
This was an observational, cross-sectional, retrospective, multicenter study conducted in Spain. During the year after authorization of the drug by the European Medicines Agency (EMA), patients in the compassionate use program (public sites) and patients treated in private sites (no purchase restrictions) who received at least 1 dose of treatment with eribulin per approved label at any of the 17 Spanish sites with the highest numbers of treated cases during that period (minimum 3 patients/site) were enrolled in this observational study. Approximately 112 patients will be enrolled in the study.
研究设计
- 研究类型
- Observational
- 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
Clinical benefit rate
时间窗: From signing of informed consent up to 1 year
次要结局
- Objective response rate(From signing of informed consent up to 1 year)
- Overall survival(From signing of informed consent up to 1 year)
- Duration of response(From signing of informed consent up to 1 year)
- Duration of stabilization(From signing of informed consent up to 1 year)
- Post-treatment survival(From signing of informed consent up to 1 year)
- Progression-free survival(From signing of informed consent up to 1 year)
- Change from baseline in tumor markers CA15-3(Baseline and up to 1 year)
- Time to response from start of treatment(From signing of informed consent up to 1 year)
- Number of patients with adverse events / serious adverse events(From signing of informed consent up to 1 year)
- Progression time after interruption(From signing of informed consent up to 1 year)