NCT00191672已完成2 期
A Phase II Randomized Trial Of Gemcitabine Plus Paclitaxel And Gemcitabine Plus Docetaxel In Patients With Metastatic Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Estimate the response rate of two regimens separately.
研究概览
简要总结
The combination of docetaxel and gemcitabine has shown significant activity in patients with metastatic breast cancer. Several studies have activity in patients of multiple lines of therapy, including patients that have been treated with prior taxane therapy. Overall responses have ranged from 30% to 79%. The major side effects of the combination chemotherapy have been neutropenia, anemia, asthenia, neuropathy, nausea, mucositis, and neutropenic fever
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Advanced or metastatic breast cancer
- •Disease that can be measured by the physician or radiologic test.
- •May have had one chemotherapy treatment for advanced or metastatic disease.
- •Patients may have received any prior adjuvant chemotherapy, including taxane containing regimens, provided this treatment was completed at least 6 months prior to enrollment.
- •Patients may have received prior hormone therapy or immunotherapy.
排除标准
- •Patients with only non-measurable disease
- •Cancer that has spread to the brain
- •A patient who received a taxane with metastatic disease.
- •Pregnancy
- •Patients who received prior gemcitabine
结局指标
主要结局
Estimate the response rate of two regimens separately.
次要结局
- Estimate the following activities of two regimens separately:Progression-free survival;Time to progressive disease;duration of response;Overall survival, changes in performance status
- Nature of toxicities experienced on each arm of the study
研究者
研究点 (2)
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