The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. The National Cancer Institute initiated the prevention trial under its National Surgical Adjuvant Breast and Bowel Project (NSABP). Listing a study does not mean it has been evaluated by the U. The National Heart, Lung, and Blood Institute provided support to obtain blood pressure and lipid measurements, and lipoprotein and selected coagulation factor measurements in a subsample. To assess the impact of tamoxifen on development of breast cancer, coronary heart disease, and bone fractures. BACKGROUND: Tamoxifen is nominally called an 'anti-estrogen' although it has some estrogen-agonist activities and tends to increase plasma endogenous estrogen levels. Several studies have confirmed that it decreases plasma total cholesterol and LDL-cholesterol and a review of mortality in patients taking tamoxifen as adjuvant therapy for breast cancer indicates a decreased number of vascular deaths in women on tamoxifen compared to those not on this agent. DESIGN NARRATIVE: Subjects were randomized to receive 10 mg of tamoxifen two times a day or to placebo. The primary endpoint was prevention of invasive breast cancer. The hormonal therapy tamoxifen (brand name: Nolvadex) is commonly used to treat men who've been diagnosed with breast cancer. Breast cancer is a rare disease in men, but it does happen. A study has found that many men have problems while taking tamoxifen and about 20% of them stop taking it (either on their own or as directed by their doctors) because of unacceptable side effects. About 2,100 new cases of invasive breast cancer are expected to be diagnosed in men in 2011. A man's lifetime risk of breast cancer is about 1 in 1,000. 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