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:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2025-12-25 @ 1:15 AM
NCT ID:
NCT00100893
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* At risk of developing breast cancer
* No history of breast cancer or ductal carcinoma in situ
PATIENT CHARACTERISTICS:
Age
* 40 to 75
Sex
* Female
Menopausal status
* Postmenopausal, defined by 1 of the following criteria:
* No spontaneous menses for ≥ 12 months
* Prior bilateral oophorectomy
* Prior hysterectomy with follicle-stimulating hormone within menopausal range
Performance status
* ECOG 0-1
Life expectancy
* Not specified
Hematopoietic
* Hemoglobin ≥ 9.0 g/dL
* Platelet count ≥ 100,000/mm\^3
* WBC ≥ 3,500/mm\^3
* Absolute granulocyte count ≥ 1,500/mm\^3
* No coagulation disorders
Hepatic
* SGOT and SGPT ≤ 2 times upper limit of normal (ULN)
* Bilirubin ≤ 1.5 times ULN
Renal
* Creatinine ≤ 1.5 times ULN
Cardiovascular
* No major illness of the cardiovascular system
Pulmonary
* No major illness of the respiratory system
Other
* No history of other invasive cancer within the past 5 years except squamous cell or basal cell skin cancer
* No major systemic infection
* No Cushing's syndrome or adrenal insufficiency
* No osteoporosis, defined as a bone mineral density T-score ≥ -2.5 on dual-energy x-ray absorptiometry scan (calcium and/or cholecalciferol \[vitamin D\] supplementation AND/OR bisphosphonate therapy allowed provided participant is on a stable dose during study participation)
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* More than 3 months since prior hormone-modifying medications, including any of the following:
* Oral contraceptives
* Hormone replacement therapy
* Selective estrogen receptor modifiers
* Aromatase inhibitors
* Gonadotropin-releasing hormone modifiers
* Concurrent dehydroepiandrosterone (DHEA) allowed, provided dose remains constant during study participation
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* No red wine, red grapes, or white button mushrooms directly before or during study treatment
* White and seedless grapes allowed
* No other concurrent therapy
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT00100893
Study Brief:
Protocol Section:
NCT00100893