DESIGN ISSUES FOR A BREAST-CANCER CHEMOPREVENTION TRIAL

被引:6
作者
DEMETS, DL
NEWCOMB, PA
CAREY, P
机构
[1] University of Wisconsin Clinical Cancer Center, Medical Science Center, Madison, WI 53706, Room 6775
关键词
D O I
10.1016/0091-7435(91)90010-2
中图分类号
R1 [预防医学、卫生学];
学科分类号
1004 ; 120402 ;
摘要
A design to evaluate the efficacy of tamoxifen as a chemopreventive agent for breast cancer in healthy, high-risk women is proposed. Factors to be considered include basic incidence rates in the general population, definition of high risk, screening efforts, sample size, and compliance to protocol. Assuming a breast cancer incidence of 3/1,000/year in women 50-59 years old with a first degree relative with breast cancer, we estimate that approximately 16,000 subjects would need to be randomized into a tamoxifen-placebo controlled trial to detect a 50% reduction in incidence. This assumes a 5% (two-sided) significance level and 90% power. Such a trial would need to be multicentered and might cost $64 million over a 5-year period. © 1991.
引用
收藏
页码:101 / 108
页数:8
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