Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2025-12-24 @ 10:19 PM
NCT ID:
NCT00673335
Eligibility 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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
69 Years
Study:
NCT00673335
Study Brief:
Protocol Section:
NCT00673335