Status:
COMPLETED
Letrozole in Preventing Breast Cancer in Postmenopausal Women With a BRCA1 or BRCA2 Mutation
Lead Sponsor:
UNICANCER
Conditions:
brca1 Mutation Carrier
brca2 Mutation Carrier
Eligibility:
FEMALE
40-69 years
Phase:
PHASE3
Brief 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...
Detailed Description
OBJECTIVES: Primary * Evaluate the reduction of the incidence of invasive breast cancer in postmenopausal women with the BRCA1/BRCA2 mutation treated with letrozole. Secondary * Determine the redu...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT00673335
Start Date
May 1 2008
End Date
December 1 2023
Last Update
July 1 2024
Active Locations (23)
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1
Institut Sainte Catherine
Avignon, France, 84082
2
Centre Regional Francois Baclesse
Caen, France, 14076
3
Centre Jean Perrin
Clermont-Ferrand, France, 63011
4
Centre Oscar Lambret
Lille, France, 59020