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 @ 3:00 PM
Ignite Modification Date:
2025-12-24 @ 3:00 PM
NCT ID:
NCT00437359
Eligibility Criteria:
Inclusion Criteria:
* Written consent obtained for study participation.
* Breast cancer diagnosed histologically with a breast removed or preserved.
* Positive ER or PR testing by immunohistochemistry (IHC), enzyme immunoassay (EIA) and who meet the criteria of each institution.
* HER2 evaluation.
* Patient Status (PS): 0 or 1.
* Fully functional heart, liver, kidneys, and bone marrow.
* More than one year since last menstruation or tested postmenopausal from estradiol (E2) and follicle-stimulating hormone (FSH) levels based on evaluation standard of each institution.
* Expected to live for at least three months (or longer) after study commencement.
Exclusion Criteria:
* Pregnant or breast feeding.
* Bilateral or inflammatory breast cancer.
* Multiple cancers.
* Life-threatening metastases.
* History of serious hypersensitivity.
* Judged ineligible for the study by the study doctor.
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT00437359
Study Brief:
Protocol Section:
NCT00437359