Study of Tamoxifen and Raloxifene (STAR) for the Prevention of Breast Cancer in Postmenopausal Women

You may be eligible if

• DISEASE CHARACTERISTICS:
• Postmenopausal women at increased risk for developing invasive breast cancer, who meet one of the following criteria:
• * At least 12 months since spontaneous menstrual bleeding
• * Prior documented hysterectomy and bilateral salpingo-oophorectomy
• * At least 55 years of age with prior hysterectomy with or without oophorectomy
• * Age 35 to 54 with a prior hysterectomy without oophorectomy OR with a status of ovaries unknown with documented follicle-stimulating hormone level demonstrating elevation in postmenopausal range
• Histologically confirmed lobular carcinoma in situ treated by local excision only OR a minimum projected 5 year probability of invasive breast cancer of at least 1.66%, using Breast Cancer Risk Assessment Profile
• No clinical evidence of malignancy on physical exam within the past 180 days
• No evidence of suspicious or malignant disease on bilateral mammogram within the past year
• No bilateral or unilateral prophylactic mastectomy
• No prior invasive breast cancer or intraductal carcinoma in situ
• Hormone receptor status:
• * Not specified
• PATIENT CHARACTERISTICS:
• Age:
• 35 and over
• Sex:
• Female
• Menopausal status:
• See Disease Characteristics
• Performance status:
• No restricted normal activity for a significant portion of each day
• Life expectancy:
• At least 10 years
• Hematopoietic:
• Granulocyte count at least 1,500/mm\^3
• Complete blood count and differential normal
• Platelet count normal
• Hepatic:
• SGOT or SGPT normal
• Bilirubin normal
• Alkaline phosphatase normal
• Renal:
• Creatinine normal
• Cardiovascular:
• No cerebral vascular accident, transient ischemic attack, atrial fibrillation, or uncontrolled hypertension
• No deep vein thrombosis
• Pulmonary:
• No pulmonary embolus
• Other:
• No other prior malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• No concurrent nonmalignant disease that would preclude administration of tamoxifen or raloxifene
• No clinical depression, psychiatric condition, or addictive disorder
• No uncontrolled diabetes
• PRIOR CONCURRENT THERAPY:
• Biologic therapy:
• Not specified
• Chemotherapy:
• Not specified
• Endocrine therapy:
• At least 3 months since prior estrogen or progesterone replacement therapy, oral contraceptives, androgens, luteinizing hormone-releasing hormone analogs, prolactin inhibitors, or antiandrogens
• At least 3 months since prior tamoxifen, raloxifene, or other selective estrogen-receptor modulators of less than 3 months duration
• Concurrent Estring allowed
• Radiotherapy:
• No prior breast radiotherapy
• Surgery:
• See Disease Characteristics
• Other:
• No prior systemic adjuvant therapy for breast cancer
• No other participation in a cancer prevention or osteoporosis prevention study involving pharmacologic intervention(s)
• * NSABP-P-1 patients who received placebo are eligible
• No concurrent warfarin or cholestyramine
• Concurrent calcitonin or nonhormonal medication (e.g., cholecalciferol, fluoride, or bisphosphonates) allowed