NCT02443428已完成不适用
Eribulin (HALAVEN) Use for the Treatment of Advanced Breast Cancer: A Prospective Observational Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 主要终点
- Number of participants with adverse events (AEs) and serious adverse events (SAEs)
研究概览
简要总结
The purpose of this prospective observational registry is to monitor safety of eribulin in routine clinical practice. Additionally, this study will also assess the effectiveness of eribulin in real-life settings.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
时间窗: From date of first administration of study drug up to 30 days after last administration of study drug or until approximately 2 years
Safety assessment will consist of monitoring of all AEs, including SAEs at every visit. All participants will be evaluable for safety from the time of their first treatment with eribulin.
次要结局
- Tumour response(From date of enrollment, Day 1 and Day 8 of every 21 day cycle or up to approximately 2 years)
- Overall survival (OS)(From date of first administration of study drug to date of death or up to approximately 2 years)
- Demographic and clinical characteristics(Up to approximately 2 years)
- Duration of treatment(Historical data collected at Baseline)
- Incidence of dose delays(From date of first administration up to approximately 2 years)
- Incidence of dose reductions(From date of first administration up to approximately 2 years)
- Relative dose intensity (RDI) of eribulin(From date of first administration up to approximately 2 years)
- Treatment patterns for locally advanced or metastatic breast cancer(Historical data collected at Baseline)
研究者
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