Letrozole in Preventing Breast Cancer in Postmenopausal Women With a BRCA1 or BRCA2 Mutation (NCT00673335) | Clinical Trial Compass
CompletedPhase 3
Letrozole in Preventing Breast Cancer in Postmenopausal Women With a BRCA1 or BRCA2 Mutation
France170 participantsStarted 2008-05
Plain-language 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.
Who can participate
Age range40 Years – 69 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 car…
What they're measuring
1
Survival without contralateral or unilateral invasive breast cancer at 5 years (prior breast cancer)
Timeframe: 2017
2
Survival without invasive breast cancer at 5 years