LY353381 in Preventing Breast Cancer in Women With Hyperplasia

DISEASE CHARACTERISTICS: Current random fine needle breast aspiration (FNA) evidence of 1 of the following: Hyperplasia with atypia Hyperplasia without atypia but with a 10-year modified Gail risk of at least 4% Hyperplasia without atypia but with a BRCAPRO risk of at least 25% Hyperplasia without atypia but with a known mutation in BRCA1 or BRCA2 Hyperplasia without atypia but with a history of contralateral ductal carcinoma in situ or invasive breast cancer FNA must have been taken during days 1-14 of the menstrual cycle for premenopausal women Classified as ACR class I-III on mammogram with stepwedge within past 6 months If intact uterus and/or ovaries, must have color doppler transvaginal pelvic sonogram within past 6 months showing endometrial thickening no greater than 13 mm premenopausal or no greater than 8 mm postmenopausal No ovarian cysts felt to be possibly or probably non-physiologic that have not resolved to gynecologist's satisfaction on repeat sonogram Must agree to have or have had genetic counseling and genetic testing performed for BRCA1 and BRCA2 No active cancer (e.g., detectable disease) Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Any Performance status: Not specified Life expectancy: At least 12 months Hematopoietic: Hemoglobin greater than 10 g/dL Granulocyte count greater than 1,000/mm^3 No deficiencies in protein C, protein S, or antithrombin III No activated protein C resistance Hepatic: Albumin greater than 3.0 g/dL Bilirubin less than 1.5 mg/dL AST less than 100 U/L Alkaline phosphatase less than 200 U/L Renal: Creatinine less than 1.5 mg/dL Cardiovascular: No history of deep venous thrombosis not related to trauma or pregnancy No severe coronary artery disease No history of prior stroke Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study No other active cancer No retinal vein thrombosis No concurrent severe poorly controlled migraine No factor V Leiden mutation carrier PRIOR CONCURRENT THERAPY: Biologic therapy: At least 12 months since prior immunotherapy Chemotherapy: At least 3 months between completion of prior KUMC phase II difluoromethylornithine (DFMO) study and baseline aspiration At least 12 months since prior chemotherapy Endocrine therapy: Must not have started or stopped hormone replacement therapy or oral contraceptives within 6 months of baseline aspiration Must continue all hormone replacement therapy and/or oral contraceptives that were being taken at time of baseline aspiration At least 12 months since prior tamoxifen, raloxifene, or other antihormonal therapy Radiotherapy: At least 3 months since prior radiotherapy Surgery: At least 6 months between prior oophorectomy and baseline aspiration Other: At least 2 weeks since the start of other new medication that would be ingested for 1 or more months