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 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
NCT ID:
NCT02344550
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 20 years
* Histologically or cytologically confirmed, HER-2 negative breast cancer with recurrent or metastatic disease
* No HER2 overexpressing breast cancer
* Premenopausal status, defined as either
* ER and/or PR positive
* Progressive disease on tamoxifen treatment or sequential or combined treatment of tamoxifen and GnRH agonist as a palliative or an adjuvant endocrine treatment
* Duration of tamoxifen treatment should be at least 3 months or more
* No prior treatment with an aromatase inhibitor or inactivator or fulvestrant, or mTOR inhibitors
* One line of chemotherapy in metastatic setting is permitted
* ECOG performance status 0,1 or 2
* At least one measurable lesion or mainly lytic bone lesions in the absence of measurable disease
* Adequate hematologic, liver and kidney function
Exclusion Criteria:
* Pregnant women or patients in lactation
* More than one line of prior chemotherapy for metastatic breast cancer
* GnRH agonist with tamoxifen treatment within 2 weeks.
* Active malignancy other than breast cancer, in situ carcinoma of the cervix, controlled resected thyroid well differentiated carcinoma or non-melanomatous skin cancer in the past 5 years
* Active cardiovascular disease such as angina, ventricular tachycardia, uncontrolled hypertension
* Active uncontrolled infection
* Symptomatic brain metastases
* Lymphangitic carcinomatosis involving \>50% of the lungs
* Evidence of metastases involving more than one third of the liver on sonogram or CT
* Patients not able or unwilling to give informed consent
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
20 Years
Study:
NCT02344550
Study Brief:
Protocol Section:
NCT02344550