Raloxifene in Preventing Breast Cancer in Premenopausal Women

You may be eligible if

• DISEASE CHARACTERISTICS:
• At risk for developing invasive breast cancer by virtue of 1 of the following criteria:
• * Gail model risk equal to that of an average 60 year old woman as determined using the Gail risk assessment model
• * Lobular neoplasia
• * Atypical ductal hyperplasia with a positive family history of breast cancer
• * Ductal carcinoma in situ previously treated with mastectomy or lumpectomy and radiation
• * BRCA1 or BRCA2 mutation-positive genotyping
• * Family history consistent with hereditary cancer syndrome of increased breast cancer risk defined as 1 of the following:
• * Family with more than 2 breast cancer cases and one or more cases of ovarian cancer diagnosed at any age
• * Family with more than 3 breast cancer cases diagnosed before age 50
• * Sister pairs with 2 breast cancers, 2 ovarian cancers, or 1 breast and 1 ovarian cancer diagnosed before age 50
• Premenopausal
• * Menstrual cycle of 26-35 days
• * No change in menstrual pattern within the past 6 months (no irregularities)
• * FSH level less than 20 mIU/mL
• Hormone receptor status:
• * Not specified
• PATIENT CHARACTERISTICS:
• Age
• 23 to 47
• Sex
• Female
• Menopausal status
• Premenopausal
• Performance status
• Not specified
• Life expectancy
• Not specified
• Hematopoietic
• No history of bleeding disorder
• Hepatic
• No history of cirrhosis of the liver
• SGOT/SGPT no greater than 3 times upper limit of normal (ULN)
• Renal
• Creatinine no greater than 1.7 mg/dL
• Cardiovascular
• No history of pulmonary embolism or deep venous thrombosis
• Other
• Not pregnant or nursing
• Negative pregnancy test
• Fertile participants must use effective non-hormonal contraception (e.g. barrier methods, spermicides, or surgical methods) during and for 3 months after study
• No history of infertility with a suspected ovarian etiology or recurrent ovarian cysts
• No allergy to raloxifene
• No dysfunctional uterine bleeding
• No menorrhagia
• No cervical dysplasia or significant uterine pathology requiring concurrent surgery
• No medical or psychiatric disorder that would preclude study participation
• Normal CA 125 levels
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• Not specified
• Chemotherapy
• Not specified
• Endocrine therapy
• At least 6 months since prior steroid therapy (e.g., tamoxifen, estrogen, DHEA, anabolic steroids, or oral contraceptives)
• Radiotherapy
• See Disease Characteristics
• Surgery
• See Disease Characteristics
• No prior hysterectomy