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 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT01597193
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed breast cancer with accompanying pathology report;
* Submit unstained representative tumor specimen, either as a paraffin block (preferred) or ≥ 10 unstained slides
* Received at least 2 lines of systemic therapy in the advanced setting (for enzalutamide alone arm only);
* Eastern Cooperative Oncology Group performance (ECOG) status of 0 or 1;
* Estimated life expectancy of at least 3 months
Exclusion Criteria:
* Severe concurrent disease, infection, or comorbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment;
* Pregnant or lactating;
* Known or suspected brain metastasis or leptomeningeal disease;
* History of another malignancy within the previous 5 years other than curatively treated in situ carcinomas;
* For patients who are enrolled to receive enzalutamide plus anastrozole or exemestane or fulvestrant must not have received tamoxifen or any medication known to be a potent CYP3A4 inducer or inhibitor.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01597193
Study Brief:
Protocol Section:
NCT01597193