ZD1839 (IRESSA) In Tamoxifen-Resistant Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Clinical benefit rate (complete response, partial response, and stable disease) for 26 weeks
研究概览
简要总结
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Hormone therapy using tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells. Combining gefitinib with tamoxifen may be effective in killing tumor cells that have become resistant (stopped responding) to tamoxifen.
PURPOSE: This randomized phase II trial is studying how well giving gefitinib together with tamoxifen works compared to gefitinib alone in treating patients with metastatic breast cancer that has stopped responding to tamoxifen.
详细描述
OBJECTIVES:
Primary
- Compare the rate of clinical benefit in patients with tamoxifen-resistant breast cancer treated with gefitinib with or without tamoxifen.
Secondary
- Determine the toxic effects of these regimens in these patients.
- Determine whether changes in fludeoxyglucose F 18 uptake by positron emission tomography scan and changes in plasma DNA levels are indicators of an early response to gefitinib in these patients.
- Determine the pharmacokinetics 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
- Triple (Participant, Care Provider, Investigator)
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
Tamoxifen
Tamoxifen 20 mg po once daily
干预措施: gefitinib (Drug)
Tamoxifen
Tamoxifen 20 mg po once daily
干预措施: tamoxifen citrate (Drug)
Placebo
Placebo comparator one tablet po once daily
干预措施: gefitinib (Drug)
Placebo
Placebo comparator one tablet po once daily
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical benefit rate (complete response, partial response, and stable disease) for 26 weeks
时间窗: 26 weeks
次要结局
未报告次要终点