NCT00005886已完成1 期
A Phase IB Randomized Study of an Antiestrogen in Women With Newly Diagnosed Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 18
研究概览
简要总结
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen or LY353381 may fight breast cancer by blocking the use of estrogen.
PURPOSE: This randomized phase I trial is studying how well tamoxifen works on the biomarkers of the tumor tissue, compared with LY353381, in treating women with newly diagnosed breast cancer.
详细描述
OBJECTIVES:
- Determine whether LY353381 hydrochloride or tamoxifen administered in the interval between biopsy and re-excision alters the expression of tissue biomarkers relative to placebo controls in postmenopausal women with newly diagnosed breast cancer.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study.
- Phase I: Patients are randomized to receive either oral LY353381 hydrochloride or oral placebo daily.
Upon completion of phase I, all treatment centers begin phase II of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 120 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究者
研究点 (18)
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