Phase III Randomized Study of Trastuzumab (Herceptin) With or Without Tamoxifen in Women With Progressive, Stage IV, Estrogen or Progesterone Receptor- and HER2/Neu-Positive Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Time to progression
研究概览
简要总结
RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen. Combining trastuzumab with tamoxifen may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of trastuzumab with or without trastuzumab in treating women who have invasive stage IV breast cancer.
详细描述
OBJECTIVES:
- Compare time to progression in women with progressive, stage IV, estrogen or progesterone receptor- and HER2/neu-positive breast cancer treated with trastuzumab (Herceptin) with or without tamoxifen.
- Correlate response with type of measurement (immunohistochemistry or fluorescent in situ hybridization) of HER2/neu expression in patients treated with these regimens.
- Compare objective response rate (complete or partial response) in patients treated with these regimens.
OUTLINE: This is a randomized study. Patients are stratified according to prior adjuvant treatment (yes vs no), ECOG performance status (0-1 vs 2), and prior aromatase inhibitor treatment (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive trastuzumab (Herceptin) IV over 60-90 minutes on day 1.
- Arm II: Patients receive trastuzumab as in arm I and oral tamoxifen once daily on days 1-21.
In both arms, treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.
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 —（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
Patients receive trastuzumab (Herceptin) IV over 60-90 minutes on day 1.
Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 5 years.
干预措施: trastuzumab (Drug)
trastuzumab + tamoxifen
Patients receive trastuzumab V over 60-90 minutes on day 1 and oral tamoxifen once daily on days 1-21.
In both arms, treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 5 years.
干预措施: tamoxifen (Drug)
trastuzumab + tamoxifen
Patients receive trastuzumab V over 60-90 minutes on day 1 and oral tamoxifen once daily on days 1-21.
In both arms, treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 5 years.
干预措施: trastuzumab (Drug)
结局指标
主要结局
Time to progression
时间窗: Up to 5 years
次要结局
- response rate(Up to 5 years)
- response(Up to 5 years)