Letrozole in Preventing Breast Cancer in Postmenopausal Women With a BRCA1 or BRCA2 Mutation

Prior treatment

• Prior cerebrovascular accident
• Prior cardiac ischemia
• Deprived of liberty or guardianship
  • PRIOR CONCURRENT THERAPY:
• At least 3 months since prior and no concurrent hormone replacement therapy (e.g., thyroid-stimulating hormone)
• No prior hormonal therapy in the past year
• No concurrent participation in another therapeutic study with an experimental drug

Other illness

• Invasive cancer diagnosed in the past 5 years, except for basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• Hypersensitivity to letrozole or its excipients, especially titanium oxide
• Renal or hepatocellular insufficiency, cholestasis, or cytolysis
• See Disease Characteristics

Other

• Geographical, social, or psychological reasons that preclude medical monitoring in this study

• Menopausal status as indicated by 1 of the following criteria:
  • Age \> 60 years
  • Bilateral oophorectomy
  • Age ≤ 60 years with no hysterectomy or amenorrhea within the past 12 months
  • Age ≤ 60 years with prior hysterectomy or FSH \> 20 IU/L
• Eastern Cooperative Oncology Group (ECOG) or WHO performance status 0-1
• absolute neutrophil count (ANC) \> 2,000/mm\^3
• Platelet count \> 100,000/mm\^3
• Hemoglobin \> 10 g/dL
• Bilirubin normal
• ALT and AST \< 2.5 times upper limit of normal
• Creatinine clearance ≥ 60 mL/min
• Adequate cardiovascular function (e.g., no history of myocardial infarction, angina pectoris, or heart failure)
• No osteoporosis by bone density scan (DEXA) within the past 2 years or prior osteoporotic fracture (femur, lumbar spine T score \> -2 DS)

Criteria the registry did not label

• DISEASE CHARACTERISTICS:
• Must meet the following criteria:
  • With or without invasive unilateral breast cancer more than 5 years ago, with no recurrence
  • No evidence of breast cancer by mammography or MRI within the past year
  • Carrier of the BRCA1/BRCA2 deleterious mutation (nonsense mutation or stop)
  • Refused preventive mastectomy
• No prior bilateral breast cancer
• No prior bilateral mastectomy
• Hormone receptor status not specified
  • PATIENT CHARACTERISTICS: