LY353381 in Preventing Breast Cancer in Women With Hyperplasia

Inclusion Criteria

• •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