Statement: There are criteria for PRIOR CONCURRENT THERAPY, PATIENT CHARACTERISTICS and DISEASE CHARACTERISTICS for entry to the primary trial.
Primary_evidence: 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