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临床试验/NCT00005886
NCT00005886已完成1 期

A Phase IB Randomized Study of an Antiestrogen in Women With Newly Diagnosed Breast Cancer

University of Kansas Medical Center18 个研究点 分布在 1 个国家开始时间: 2000年7月最近更新:
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

入选标准

  • 未提供

排除标准

  • 未提供

研究者

申办方类型
Other
责任方
Sponsor

研究点 (18)

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