Docetaxel And Vinorelbine Plus Filgrastim For HER-2 Negative, Stage IV Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 99
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of combining docetaxel, vinorelbine, and filgrastim in treating women who have stage IV breast cancer.
详细描述
OBJECTIVES:
- Determine the 1-year survival of women with HER-2-negative stage IV breast cancer treated with docetaxel, vinorelbine, and filgrastim (G-CSF).
- Determine the response rate (both complete and partial response) and time to progression in patients treated with this regimen.
- Determine the qualitative and quantitative toxic effects of this regimen in this patient population.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 1 hour on day 1, vinorelbine IV over 6-10 minutes on days 8 and 15, and filgrastim (G-CSF) subcutaneously on days 2-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for 3 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
- Female
- 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
treatment
docetaxel and vinorelbine with filgrastim support
干预措施: filgrastim (Biological)
treatment
docetaxel and vinorelbine with filgrastim support
干预措施: docetaxel (Drug)
treatment
docetaxel and vinorelbine with filgrastim support
干预措施: vinorelbine (Drug)