Randomized Phase II Trial of Gemcitabine and Imatinib Mesylate Versus Gemcitabine Alone in Patients With Previously Treated Locally Advanced or Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 49
- 试验地点
- 9
- 主要终点
- Time to Progression
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine together with imatinib mesylate may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying gemcitabine and imatinib mesylate to see how well they work compared to gemcitabine alone in treating patients with previously treated locally advanced or metastatic breast cancer.
详细描述
OBJECTIVES:
Primary
- Compare time to progression in patients with previously treated locally advanced or metastatic breast cancer treated with gemcitabine hydrochloride with vs without imatinib mesylate.
Secondary
- Compare the efficacy of these regimens in these patients.
- Compare the overall survival of patients treated with these regimens.
- Compare the safety and tolerability of these regimens in these patients.
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 120 Years（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
Arm I (Gemcitabine Hydrochloride)
Patients receive gemcitabine hydrochloride IV on days 3 and 10.
干预措施: gemcitabine hydrochloride (Drug)
Arm II (Gemcitabine Hydrochloride + Imatinib)
Patients receive gemcitabine hydrochloride IV on days 3 and 10 and oral imatinib mesylate once daily on days 1-5 and 8-12.
干预措施: gemcitabine hydrochloride (Drug)
Arm II (Gemcitabine Hydrochloride + Imatinib)
Patients receive gemcitabine hydrochloride IV on days 3 and 10 and oral imatinib mesylate once daily on days 1-5 and 8-12.
干预措施: imatinib mesylate (Drug)
结局指标
主要结局
Time to Progression
时间窗: 5 years
Sample size of 40 patients per group was needed to detect an 8 month increase in time to progression with the combination (80% power, alpha =.05, 2-sided).
次要结局
- Response Rate (Complete and Partial Response)(5 years)
- Overall Survival(5 years)
研究者
Deborah Toppmeyer, MD
Chief, Division of Medical Oncology
Rutgers, The State University of New Jersey