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 @ 11:29 PM
Ignite Modification Date:
2025-12-24 @ 11:29 PM
NCT ID:
NCT01249456
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent form
* Postmenopausal patients who had had a histologically or cytologically confirmed breast cancer removed at the time of diagnosis with no evidence of metastases and who had completed over 5 years of adjuvant therapy with tamoxifen or toremifen before entering the study
* Age ≥50 years with cessation of menses and Age \<50 years Postmenopausal status defined by one of the following:
* FSH level \> 30-40 IU/L
* cessation of menses over the past 1 year
* are/become amenorrheic due to either chemotherapy or LHRH, are/become amenorrheic due to surgical ovarian ablation
* The tumor was to be ER and/or PgR-positive or the receptor status could have been unknown
* No evidence of recurrence of the disease at entry
* Patient must be accessible for follow-up
Exclusion Criteria:
* Those patients known to have had receptor-negative primary tumors
* Any concurrent malignancy
* Patients who previously received hormone replacement therapy (HRT) during 5 years of adjuvant therapy with tamoxifen or toremifen
* Patients who are currently receiving other aromatase inhibitors, or chemotherapy
* Patients who have serious cardiovascular or hepatic disease with significantly abnormal daily function and/or laboratory results
* Life expectancy \< 12 months
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT01249456
Study Brief:
Protocol Section:
NCT01249456