Raloxifene and Goserelin in Preventing Breast Cancer in Women With a Family History of Breast Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •High genetic risk of developing breast cancer defined as one or more of the following:
• •* BRCA1 or BRCA2 germ-line mutation
• •* First-degree relative of known BRCA1 or BRCA2 mutation carrier
• •* Family with 4 or more relatives diagnosed with female or male breast cancer or ovarian cancer before the age of 60
• •* Two first-degree relatives diagnosed with breast cancer before the age of 40
• •* p53 germ-line mutation (classical Li-Fraumeni syndrome (LFS) only)
• •* First-degree relative of a carrier in a family with classical LFS
• •* Risk equivalent to any of the above confirmed by clinical geneticist
• •No evidence of breast cancer by mammography
• •* Suspicious lesions must be confirmed as non-malignant
• •No prior breast cancer
• •No prior prophylactic mastectomy
• •No plan for alternative prevention measures within the next 12 months
• •Hormone receptor status:
• •* Not specified
• •PATIENT CHARACTERISTICS:
• •Age:
• •30 to 45
• •Sex:
• •Female
• •Menopausal status:
• •Premenopausal (follicle-stimulating hormone in premenopausal range if not menstruating)
• •Performance status:
• •Not specified
• •Life expectancy:
• •More than 10 years (excluding breast cancer risk)
• •Hematopoietic:
• •Not specified
• •Hepatic:
• •Adequate liver function
• •Renal:
• •Adequate renal function
• •Cardiovascular:
• •No prior deep vein thrombosis
• •Pulmonary:
• •No prior pulmonary embolism
• •Other:
• •Not pregnant
• •Fertile patients must use effective nonhormonal contraception
• •No psychological disorder that would preclude study compliance
• •No prior malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or cervical cancer
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy:
• •Not specified
• •Chemotherapy:
• •Not specified
• •Endocrine therapy:
• •No concurrent hormonal therapy (e.g., oral contraception or hormone replacement therapy)
• •Radiotherapy:
• •Not specified
• •Surgery:
• •See Disease Characteristics
• •Other:
• •At least 30 days or 5 half-lives since prior investigational drugs
• •No concurrent anticoagulants