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 @ 4:36 PM
Ignite Modification Date:
2025-12-24 @ 4:36 PM
NCT ID:
NCT00719966
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of breast cancer
* Ductal carcinoma in situ (DCIS) allowed provided the patient will not receive tamoxifen as part of treatment for their cancer
* May not have had a prior mastectomy with requirement for mastectomy of the contralateral breast
* No requirement for axillary lymph node dissection with a history of contralateral mastectomy and/or contralateral axillary lymph node dissection
* Hormone receptor status meeting 1 of the following criteria:
* Hormone receptor negative and not eligible for aromatase inhibitor therapy (AI)
* Hormone receptor positive and are not receiving an AI
PATIENT CHARACTERISTICS:
* Postmenopausal
* No known or symptomatic coronary artery disease
* No significant co-morbidities, including any of the following conditions:
* Active renal or hepatic disease
* Known uncontrolled and/or untreated peripheral arterial disease
* Uncontrolled and/or untreated hypertension
* Uncontrolled and/or untreated diabetes
* Uncontrolled and/or untreated hyperlipidemia
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* More than 7 days since prior hormone replacement therapy or hormone-based contraception
* More than 12 months since prior and no concurrent tamoxifen or aromatase inhibitor therapy for this disease
* More than 12 months since prior and no concurrent chemotherapy for this disease
* No prior bilateral mastectomy
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT00719966
Study Brief:
Protocol Section:
NCT00719966