跳至主要内容
临床试验/NCT02769364
NCT02769364已完成不适用

Long-term Eribulin Treatment in Metastatic Breast Cancer: A Multicenter, Case-study Analysis

Eisai Limited0 个研究点目标入组 45 人开始时间: 2013年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Eisai Limited
入组人数
45
主要终点
Objective response rate

研究概览

简要总结

Decision-making for treatment of metastatic breast cancer after the second line of chemotherapy was limited by the lack of established predictive factors of benefit for further chemotherapy regimens. Eribulin has emerged as the only single agent demonstrating an overall survival improvement in the third-line setting or beyond. The purpose of this study was to define the clinical profile of metastatic breast cancer participants achieving long-term benefit from chemotherapy with eribulin in the third-line setting or beyond.

详细描述

This was a multicenter, retrospective, observational, case study analysis to assess long-term eribulin treatment in metastatic breast cancer. The study was conducted in 26 Spanish hospitals participating in a national pre-market access program to eribulin between 2011 and 2014. An exploratory comparison with a group of short-term responders included in a similar observational study was performed.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Objective response rate

时间窗: up to 7 months

Post progression survival

时间窗: up to 7 months

Progression free survival (PFS)

时间窗: up to 7 months

Time to response

时间窗: up to 7 months

Overall survival

时间窗: up to 7 months

次要结局

  • Number of participants with adverse events/serious adverse events/toxic deaths as a measure of safety(up to 7 months)

研究者

发起方
Eisai Limited
申办方类型
Industry
责任方
Sponsor

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