Phase II Trial of Vinfluinine and Capecitabine in Previously Treated Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Confirmed tumor response
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as vinflunine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving vinflunine together with capecitabine works in treating patients with previously treated metastatic breast cancer.
详细描述
OBJECTIVES:
Primary
- Evaluate the tumor response rate in patients with previously treated metastatic breast cancer treated with vinflunine and capecitabine.
Secondary
- Describe the adverse event profile of this regimen in these patients.
- Determine the progression-free survival of patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
- Determine the duration of response in patients treated with this regimen.
- Determine the time to treatment failure in patients treated with this regimen.
- Describe the quality of life of patients treated with this regimen.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
vinflunine + capecitabine
Patients receive vinflunine IV over 20 minutes on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, every other course, and at the completion of study treatment.
After completion of study treatment, patients are followed periodically for up to 5 years.
干预措施: capecitabine (Drug)
vinflunine + capecitabine
Patients receive vinflunine IV over 20 minutes on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, every other course, and at the completion of study treatment.
After completion of study treatment, patients are followed periodically for up to 5 years.
干预措施: vinflunine (Drug)
结局指标
主要结局
Confirmed tumor response
时间窗: Up to 10 years
次要结局
- Overall survival(Up to 10 years)
- Quality of life(Up to 10 years)
- Duration of response(Up to 10 years)
- Time to treatment failure(Up to 10 years)
- Adverse event profile(Up to 10 years)
- Progression-free survival(Up to 10 years)