IH636 Grape Seed Extract in Preventing Breast Cancer in Postmenopausal Women at Risk of Developing Breast Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •At risk of developing breast cancer
• •No history of breast cancer or ductal carcinoma in situ
• •PATIENT CHARACTERISTICS:
• •Age
• •40 to 75
• •Sex
• •Female
• •Menopausal status
• •Postmenopausal, defined by 1 of the following criteria:
• •* No spontaneous menses for ≥ 12 months
• •* Prior bilateral oophorectomy
• •* Prior hysterectomy with follicle-stimulating hormone within menopausal range
• •Performance status
• •ECOG 0-1
• •Life expectancy
• •Not specified
• •Hematopoietic
• •Hemoglobin ≥ 9.0 g/dL
• •Platelet count ≥ 100,000/mm\^3
• •WBC ≥ 3,500/mm\^3
• •Absolute granulocyte count ≥ 1,500/mm\^3
• •No coagulation disorders
• •Hepatic
• •SGOT and SGPT ≤ 2 times upper limit of normal (ULN)
• •Bilirubin ≤ 1.5 times ULN
• •Renal
• •Creatinine ≤ 1.5 times ULN
• •Cardiovascular
• •No major illness of the cardiovascular system
• •Pulmonary
• •No major illness of the respiratory system
• •Other
• •No history of other invasive cancer within the past 5 years except squamous cell or basal cell skin cancer
• •No major systemic infection
• •No Cushing's syndrome or adrenal insufficiency
• •No osteoporosis, defined as a bone mineral density T-score ≥ -2.5 on dual-energy x-ray absorptiometry scan (calcium and/or cholecalciferol \[vitamin D\] supplementation AND/OR bisphosphonate therapy allowed provided participant is on a stable dose during study participation)
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •Not specified
• •Chemotherapy
• •Not specified
• •Endocrine therapy
• •More than 3 months since prior hormone-modifying medications, including any of the following:
• •* Oral contraceptives
• •* Hormone replacement therapy
• •* Selective estrogen receptor modifiers
• •* Aromatase inhibitors
• •* Gonadotropin-releasing hormone modifiers
• •Concurrent dehydroepiandrosterone (DHEA) allowed, provided dose remains constant during study participation
• •Radiotherapy
• •Not specified
• •Surgery
• •Not specified
• •Other
• •No red wine, red grapes, or white button mushrooms directly before or during study treatment
• •* White and seedless grapes allowed
• •No other concurrent therapy