Phase II Trial of Sorafenib and Paclitaxel for Measurable Metastatic HER2-Negative Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Time to Tumor Progression
研究概览
简要总结
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with paclitaxel may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving sorafenib together with paclitaxel and to how well it works in treating patients with metastatic breast cancer.
详细描述
OBJECTIVES:
Primary
- To evaluate the efficacy of sorafenib tosylate and paclitaxel by measuring tumor response, as defined by RECIST criteria, in patients with metastatic, HER2-negative breast cancer.
Secondary
- To evaluate time to disease progression in patients treated with this regimen.
- To evaluate six-month progression-free survival of patients treated with this regimen.
- To evaluate time to treatment failure in patients treated with this regimen.
- To evaluate clinical benefit rate (tumor response and stable disease) at 24 weeks in patients treated with this regimen.
- To evaluate duration of response in patients treated with this regimen.
- To evaluate the tolerability of this regimen in these patients.
- To examine the relationship of gene expression and tissue/serum protein markers, where available, related to response to therapy focusing on growth factor receptor pathways.
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
Sorfenib + Paclitaxel
Oral sorafenib tosylate twice daily on days 1-28 and paclitaxel IV over 1 hour on days 1, 8, and 15
干预措施: paclitaxel (Drug)
Sorfenib + Paclitaxel
Oral sorafenib tosylate twice daily on days 1-28 and paclitaxel IV over 1 hour on days 1, 8, and 15
干预措施: sorafenib tosylate (Drug)
结局指标
主要结局
Time to Tumor Progression
时间窗: Time from first treatment to disease progression or death (up to 36 months)
Progression-free survival was defined as the time of treatment to the earliest date of documentation of disease progression or death due to any cause. In the case of a participant started treatment. Tenth month of progression-free rate of sorafenib and paclitaxel will be compared agains the null progression free rate of 32% using normal approximation test.
次要结局
- Clinical Benefit Rate (Tumor Response and Stable Disease) at 24 Weeks(24 weeks)
- Tolerability of Sorafenib/Paclitaxel Regimen(Up to 36 months)
- Tumor Response Rate(Up to 36 months)
- Time to Treatment Failure(Up to 36 months)
- Six-month Progression-free Survival(6 months)
- Duration of Response(Up to 36 months)
- Determine the Relationship of Gene Expression and Tissue/Serum Protein Markers, Where Available, Related to Response to Therapy Focusing on Growth Factor Receptor Pathways.(Up to 36 months)
研究者
Barbara Haley
Professor of Medicine
University of Texas Southwestern Medical Center