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 @ 12:15 AM
Ignite Modification Date:
2025-12-25 @ 12:15 AM
NCT ID:
NCT02362958
Eligibility Criteria:
Inclusion Criteria:
* Metastatic breast cancer
* Eastern Cooperative Oncology Group (ECOG) 0 or 1
* HER2-expressing primary or metastatic tumor
* Recurrence within 1 year completing adjuvant trastuzumab OR rapid progress following first-line trastuzumab-based care.
* Measurable disease with Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
* Normal organ function, including bone marrow function, renal function, liver function, and cardiac function
* Signed and dated an informed consent form
* Life expectancy of at least 12 weeks
Exclusion Criteria:
* Pregnant or breast feeding
* left ventricular ejection fraction (LVEF) \< 45% by echocardiogram
* Disease-free interval (DFI) less than 12 months
* Uncontrolled medical problems
* Any previous malignancy exceptions for carcinoma of the cervix, squamous carcinoma of the skin, or basal cell carcinoma of the skin
* Patients were unable or unwilling to comply with program requirements
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02362958
Study Brief:
Protocol Section:
NCT02362958