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 @ 5:09 PM
Ignite Modification Date:
2025-12-24 @ 5:09 PM
NCT ID:
NCT02910050
Eligibility Criteria:
Inclusion Criteria:
* Patients with histologically confirmed estrogen receptor positive, androgen positive and HER2 negative breast cancer
* Metastatic or unresectable locally advanced disease
* Age over 18 years
* Postmenopausal status （continuous using luteinizing hormone releasing hormone(LHRH) analogue is available）
* Patient must have disease progression after treatment of an Aromatase inhibitor.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS)0-2
* Life expectancy over 3 months.
* Measurable disease according to RECIST version 1.1 or only bone metastasis
* Adequate hematological, hepatic function.
* Voluntarily signed and dated written informed consent prior to any study specific procedure.
Exclusion Criteria:
* Patient with life-threatening visceral metastasis, such as extensive liver metastasis, brain or meningeal metastasis
* Concomitant diseases/conditions that is not controllable, and Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study.
* History of other primary malignancy
* Resistant to steroidal or nonsteroidal aromatase Inhibitor
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02910050
Study Brief:
Protocol Section:
NCT02910050