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 @ 2:36 AM
Ignite Modification Date:
2025-12-25 @ 2:36 AM
NCT ID:
NCT00343434
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Previously diagnosed stage I-III breast cancer currently in complete remission
* Completed treatment for breast cancer ≥ 6 months ago
* Free of disease at last clinic visit
* Body mass index ≥ 27
* Hormone receptor status
* Estrogen receptor (ER)/progesterone receptor (PR) negative
PATIENT CHARACTERISTICS:
* Female
* Menopausal status not specified
* No history of soy allergies
* No uncontrolled blood pressure
* No uncontrolled hyperthyroidism or hypothyroidism
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No diabetes mellitus (type 1 or 2)
* No medical, psychiatric, or behavioral factors that would preclude study participation
* No definite plans to move out of the area during the study period
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No concurrent medications for weight loss
* No concurrent treatment for ER/PR-negative disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
120 Years
Study:
NCT00343434
Study Brief:
Protocol Section:
NCT00343434