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 @ 7:07 PM
Ignite Modification Date:
2025-12-24 @ 7:07 PM
NCT ID:
NCT00090857
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* At increased risk for the development or recurrence of breast cancer, defined as an estradiol level ≥ 9 pg/mL
* No evidence of suspicious or malignant disease, based on the following examinations:
* Clinical bilateral breast examination within the past 6 months
* Bilateral\* mammogram within 3 months before randomization OR within 30 days after randomization
* Pelvic exam normal within the past 5 years
* General physical exam within the past 6 months NOTE: \*Unilateral mammogram of the uninvolved breast for patients with prior invasive breast cancer or ductal carcinoma in situ (DCIS)
* Bone density scan within 2 standard deviations from normal within the past 30 days
* Bone density scan ≥ 2 standard deviations below normal allowed if approved by the study physician
* At least 1 breast that has not been previously treated with radiotherapy or surgery (for patients with prior invasive breast cancer or DCIS)
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age
* 35 and over
Sex
* Female
Menopausal status
* Postmenopausal, defined by any of the following criteria:
* At least 12 months without spontaneous menstrual bleeding
* Prior hysterectomy and bilateral salpingo-oophorectomy
* ≥ 55 years of age with a prior hysterectomy with or without oophorectomy
* \< 55 years of age with a prior hysterectomy without oophorectomy OR the status of the ovaries is unknown AND follicle-stimulating hormone (FSH) level is in the postmenopausal range
Performance status
* Normal activity must not be restricted for a significant portion of the day
Life expectancy
* At least 10 years
Hematopoietic
* Complete blood count with differential normal
* Prior benign neutropenia allowed provided the granulocyte count is ≥ 1,500/mm\^3
Hepatic
* Bilirubin normal
* Alkaline phosphatase normal
* SGOT and SGPT normal
Renal
* Creatinine normal
Cardiovascular
* No uncontrolled cardiovascular disease
Other
* Not pregnant
* No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* No osteoporosis
* No hyperlipidemia
* No mental health status resulting in cognitive or emotional impairment that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* More than 30 days since prior AND no concurrent use of any of the following hormonal agents:
* Estrogen or progesterone replacement therapy
* Oral contraceptives
* Raloxifene or other plasma estrogen receptor modulators (SERMs)
* Androgens (e.g., danazol)
* Luteinizing hormone-releasing hormone (LHRH) analogs (e.g., goserelin or leuprolide)
* Prolactin inhibitors (e.g., bromocriptine)
* Antiandrogens (e.g., cyproterone)
* More than 60 days since prior AND no concurrent tamoxifen
* No prior aromatase inhibitors (for patients with prior invasive breast cancer or DCIS)
* No concurrent phytoestrogenic dietary supplements (e.g., soy, ginseng, or other natural products)
* Dietary soy allowed
Radiotherapy
* See Disease Characteristics
Surgery
* See Disease Characteristics
* No prior bilateral mastectomy
Other
* More than 60 days since prior treatment for invasive breast cancer or DCIS
* More than 30 days since prior bisphosphonates or calcitonin
* No prior or concurrent participation on a treatment study for invasive breast cancer or DCIS
* No concurrent participation in any other cancer prevention study or osteoporosis prevention study involving pharmacologic agents
* No concurrent calcitonin
* No concurrent bisphosphonate therapy
* Concurrent cholecalciferol (vitamin D) and calcium to augment bone mineral density allowed
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
35 Years
Maximum Age:
120 Years
Study:
NCT00090857
Study Brief:
Protocol Section:
NCT00090857