Activity and Toxicity Profile of Eribulin Mesylate in Pretreated Metastatic Breast Cancer: an Observational Multicentric Retroprospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 753
- 试验地点
- 12
- 主要终点
- Overall Survival
研究概览
简要总结
The objective of this observatory is to evaluate the effecacy of Eribulin in patients with metastatic breast cancer on a recent prescription period.
Part of the data collection will be retrospective and the other part will be prospective for patients started treatment by Eribulin between November 2014 and September 2015. It will allow a better assessment on the safety profile of this drug.
详细描述
Approximately one third of patients treated for localized breast cancer will present a metastatic evolution and 5% of patients are metastatic immediately.
At this stage, the malignancy is incurable with a median survival from 2 to 3 years.
Metastatic breast cancer treatment is part of a multidisciplinary approach. These two objectives are to prolong survival and improve quality of life. At present, there is no standard after the first line of chemotherapy, with fe strategy studies Eribulin is now a new therapeutic option to consider. Many patients have benefited from this treatment option and it seems interesting to evaluate in real life the effecacy and tolerance of chemotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Patient with breast cancer, histologically proven, metastatic or locally advanced
- •Patient treated by Eribulin between January and October 2014 (for the retrospective part) or between November 2014 and September 2015 (for the prospective part).
- •Patient with at least an assessment of the response to Eribulin
排除标准
- •Presence of other neoplasia
结局指标
主要结局
Overall Survival
时间窗: 1 year
Overall survival is defined as the time between the first administration of Eribulin and death from any cause.
次要结局
- Overall Survival by subgroup(1 year)
- Progression free survival(1 year)
- Treatment response rate(1 year)
- Treatment's tolerance(1 year)