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 @ 5:14 PM
Ignite Modification Date:
2025-12-24 @ 5:14 PM
NCT ID:
NCT00031850
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* High genetic risk of developing breast cancer defined as one or more of the following:
* BRCA1 or BRCA2 germ-line mutation
* First-degree relative of known BRCA1 or BRCA2 mutation carrier
* Family with 4 or more relatives diagnosed with female or male breast cancer or ovarian cancer before the age of 60
* Two first-degree relatives diagnosed with breast cancer before the age of 40
* p53 germ-line mutation (classical Li-Fraumeni syndrome (LFS) only)
* First-degree relative of a carrier in a family with classical LFS
* Risk equivalent to any of the above confirmed by clinical geneticist
* No evidence of breast cancer by mammography
* Suspicious lesions must be confirmed as non-malignant
* No prior breast cancer
* No prior prophylactic mastectomy
* No plan for alternative prevention measures within the next 12 months
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age:
* 30 to 45
Sex:
* Female
Menopausal status:
* Premenopausal (follicle-stimulating hormone in premenopausal range if not menstruating)
Performance status:
* Not specified
Life expectancy:
* More than 10 years (excluding breast cancer risk)
Hematopoietic:
* Not specified
Hepatic:
* Adequate liver function
Renal:
* Adequate renal function
Cardiovascular:
* No prior deep vein thrombosis
Pulmonary:
* No prior pulmonary embolism
Other:
* Not pregnant
* Fertile patients must use effective nonhormonal contraception
* No psychological disorder that would preclude study compliance
* No prior malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or cervical cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Not specified
Endocrine therapy:
* No concurrent hormonal therapy (e.g., oral contraception or hormone replacement therapy)
Radiotherapy:
* Not specified
Surgery:
* See Disease Characteristics
Other:
* At least 30 days or 5 half-lives since prior investigational drugs
* No concurrent anticoagulants
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
30 Years
Maximum Age:
45 Years
Study:
NCT00031850
Study Brief:
Protocol Section:
NCT00031850