Bexarotene in Preventing Breast Cancer in Women at Genetic Risk

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Known carrier of a BRCA-1 or BRCA-2 mutation
• •* Copy of laboratory report stating results must be available for review OR
• •At risk for carrying a BRCA-1 or BRCA-2 mutation
• •* At least 10% risk by Parmigiana probability model
• •Must have at least 1 breast that has never been involved with cancer and has not been irradiated
• •Hormone receptor status:
• •* Not specified
• •PATIENT CHARACTERISTICS:
• •Age
• •18 and over
• •Sex
• •Female
• •Menopausal status
• •Not specified
• •Performance status
• •Not specified
• •Life expectancy
• •Not specified
• •Hematopoietic
• •WBC greater than 4,000/mm\^3
• •Platelet count greater than 100,000/mm\^3
• •Hematocrit greater than 30%
• •Hepatic
• •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• •ALT no greater than 1.5 times ULN
• •Alkaline phosphatase no greater than 1.5 times ULN
• •Albumin no greater than 1.5 times ULN
• •No biliary tract disease
• •Renal
• •Creatinine no greater than 1.5 times ULN
• •Other
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception for 1 month before, during, and for 1 month after study therapy
• •Triglycerides normal
• •Thyroid-stimulating hormone and thyroxine normal
• •Willing to undergo 2 duplicate needle biopsies of the breast
• •Willing to undergo genetic testing for BRCA-1 and BRCA-2
• •No uncontrolled hyperlipidemia
• •No nontoxic goiter or thyroid enlargement
• •No severe underlying chronic illness or disease
• •No uncontrolled diabetes
• •No history of pancreatitis
• •No cancer within the past year except skin cancer or carcinoma in situ of the cervix (defined from the date of first diagnosis)
• •No concurrent alcohol use (greater than 3 drinks or its equivalent per day)
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •Not specified
• •Chemotherapy
• •More than 1 year since prior chemotherapy for a neoplasm
• •Endocrine therapy
• •More than 3 months since prior postmenopausal hormonal therapy (including estrogens or progestins)
• •More than 3 months since prior tamoxifen or other selective estrogen-receptor modulators
• •No concurrent hormone replacement therapy
• •Concurrent thyroid hormone supplementation allowed
• •Radiotherapy
• •See Disease Characteristics
• •Surgery
• •Not specified
• •Other
• •More than 30 days since prior investigational medications
• •More than 3 months since prior oral vitamin A supplements greater than the recommended daily requirement (5,000 IU) or therapeutic oral or topical vitamin A derivatives (e.g., isotretinoin)
• •No concurrent participation in a study of an investigational agent
• •No concurrent medications known to be associated with pancreatic toxicity or to increase triglyceride levels