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

• Status: Active, not recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Letrozole may prevent breast cancer in postmenopausal women with a BRCA1 or BRCA2 mutation.

PURPOSE: This randomized phase III trial is studying letrozole to see how well it works compared with a placebo in preventing breast cancer in postmenopausal women with a BRCA1 or BRCA2 mutation.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNICANCER
• Treatments: Letrozole

Criteria

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:

Inclusion criteria:

• 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)

Exclusion criteria:

• Invasive cancer diagnosed in the past 5 years, except for basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

• Prior cerebrovascular accident

• Prior cardiac ischemia

• Hypersensitivity to letrozole or its excipients, especially titanium oxide

• Renal or hepatocellular insufficiency, cholestasis, or cytolysis

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

• Deprived of liberty or guardianship

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• 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