Assessment of Abraxane in Metastatic Breast Cancer in a Real-life Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 203
- 试验地点
- 13
- 主要终点
- Adverse Events
研究概览
简要总结
This observational project is collecting tolerability, safety and efficacy data with the routine use of Abraxane in the treatment of metastatic breast cancer. Additionally data on the dosage of Abraxane and general data on the disease and the health status of the patient will be collected.
详细描述
This observational program is aimed at gaining tolerability, safety and efficacy data with the routine use of Abraxane in its labelled indication in metastatic breast cancer. Additionally data on real life dosing in daily clinical routine will be analyzed.
A detailed record of the medical history including co-morbidities and pre-treatment regimens will allow analysis of the impact thereof on tolerability, dosage and efficacy.
This data might also be supportive for further treatment optimization of Abraxane in Metastatic Breast Cancer (MBC).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Patients with metastatic breast cancer (according to European Summary of Product characteristics (SmPC)
- •Signed Informed Consent
- •Participants > 18 Years of Age
排除标准
- •Pregnant or lactating females
- •Neutrophils <1.5 X 10^9/L
- •Hypersensivity to nab-paclitaxel
研究组 & 干预措施
nab-paclitaxel
nab-paclitaxel 260mg/m^2 in intravenous (IV) infusion every 3 weeks until progression or toxicity
干预措施: nab-paclitaxel (Drug)
结局指标
主要结局
Adverse Events
时间窗: Up to 3 years
Includes the number of participants with adverse events
次要结局
- Overall Response(Up to 3 years)