NCT01550848已完成2 期
A Phase II Study of Abraxane Combined With Gemcitabine in the Patients With Metastatic Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- overall response rate
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and toxicity of Abraxane combined with Gemcitabine in the patients with metastatic breast cancer.
详细描述
This study is to investigate the efficacy and toxicity of Abraxane combined with Gemcitabine in the patients with metastatic breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female between 18 and 70 years old;
- •Patients with histologic proved metastatic breast cancer, unsuitable to be treated with surgery;
- •ECOG (Eastern Cooperative Oncology Group) 0~1;
- •Normal functions with heart, liver,renal and bone marrow:WBC≥3.5×109/L；Hb≥90 g/L；plt≥100×109/L;
- •Got ICF (Informed Consent Form) before enrollment;
- •Life expectancy more than 12 weeks
排除标准
- •Pregnant or breast-feeding women or positive serum pregnancy test;
- •Uncontrolled brain metastases. Patients with brain metastases must be locally treated and the disease must be stable for at least one month at the time of enrolling;
- •Participation in any investigational drug study within 4 weeks preceding treatment start;
- •Concurrent other malignancy at other sites or previous other cancer within the last 5 years, with the exception of adequately treated in situ carcinoma of cervix uteri or basal or squamous cell carcinoma of the skin or a contralateral breast cancer;
- •Serious uncontrolled intercurrent infections;
- •Poor compliance
研究组 & 干预措施
Abraxane and Gemcitabine
Experimental
Abraxane and Gemcitabine
干预措施: Abraxane and Gemcitabine (Drug)
结局指标
主要结局
overall response rate
时间窗: 8 weeks
次要结局
- number of adverse events(6 months)
研究者
Xichun Hu
Principal Investigator
Fudan University
研究点 (1)
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