Phase II Trial of CT-2103 (Xyotax™) With Capecitabine as First-Line Chemotherapy for Patients With Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 主要终点
- Proportion of confirmed tumor response (complete and partial response) as assessed by RECIST criteria
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as paclitaxel poliglumex 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 paclitaxel poliglumex together with capecitabine works in treating patients with metastatic breast cancer.
详细描述
OBJECTIVES:
- Assess the tumor response rate and adverse event profile in patients with metastatic, HER2 negative breast cancer treated with paclitaxel poliglumex (CT-2103; Xyotax™) and capecitabine.
- Examine the distributions of disease-free progression times and survival times in these patients.
OUTLINE: This is a multicenter study.
Patients receive paclitaxel poliglumex IV (CT-2103; Xyotax™) over 10-20 minutes on day 1 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 6 months for up to 5 years.
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
paclitaxel + capecitabine
Patients receive paclitaxel poliglumex IV (CT-2103; Xyotax™) over 10-20 minutes on day 1 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 6 months for up to 5 years.
干预措施: capecitabine (Drug)
paclitaxel + capecitabine
Patients receive paclitaxel poliglumex IV (CT-2103; Xyotax™) over 10-20 minutes on day 1 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 6 months for up to 5 years.
干预措施: paclitaxel poliglumex (Drug)
结局指标
主要结局
Proportion of confirmed tumor response (complete and partial response) as assessed by RECIST criteria
时间窗: Up to 5 years
次要结局
- Time to disease progression(Up to 5 years)
- Survival time(Up to 5 years)