Weekly Trastuzumab (Herceptin) and Irinotecan in Patients With HER-2 Positive Advanced Breast Cancer: A Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Overall objective response rate (partial and complete responses)
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving trastuzumab together with irinotecan may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving trastuzumab together with irinotecan works in treating patients with HER2/neu positive metastatic breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine the overall objective response-rate (partial and complete) and stable disease rate in patients with HER2/neu positive metastatic breast cancer treated with the combination of irinotecan hydrochloride and trastuzumab (Herceptin®) after prior first- or second-line therapy with trastuzumab combined with other chemotherapeutic agents.
Secondary
- Determine the toxicities of this combination regimen.
- Determine the duration of response and time to disease progression in patients treated with this combination.
- Document development of brain metastases or progression of known metastases in 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
- — 至 120 Years（Child, 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
Trastuzumab and Irinotecan
干预措施: trastuzumab (Biological)
Trastuzumab and Irinotecan
干预措施: irinotecan hydrochloride (Drug)
结局指标
主要结局
Overall objective response rate (partial and complete responses)
时间窗: up to 20 months post treatment
Stable disease rate
时间窗: up to 20 months post treatment
次要结局
- Duration of response(up to 20 months post treatment)
- Toxicity(up to 20 months post treatment)
- Development of brain metastases or progression of known metastases on this treatment(up to 20 months post treatment)
- Time to disease progression(up to 20 months post treatment)