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 @ 3:33 PM
Ignite Modification Date:
2025-12-24 @ 3:33 PM
NCT ID:
NCT02491892
Eligibility Criteria:
Inclusion Criteria:
* Females at least 18 years of age
* Histologically-confirmed metastatic breast cancer with low HER2 expression and at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST)
* Karnofsky performance status at least 80%
* Disease progression on/after up to 2 different chemotherapy regimens, including an anthracycline-containing therapy
* Left ventricular ejection fraction (LVEF) at least 50%
* Adequate liver function
Exclusion Criteria:
* Pleural effusions, ascites, or bone lesions as the only manifestation(s) of cancer
* Pulmonary or central nervous system (CNS) metastases
* Chemotherapy, radiotherapy, or immunotherapy within 4 weeks; or hormone therapy within 2 weeks of Day 1
* Previous treatment with any drug that targets the HER2 receptor family
* Previous treatment with corticosteroids as cancer therapy
* History of significant cardiac disease
* Major surgery or trauma within 4 weeks of Day 1
* Pregnant or lactating women
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02491892
Study Brief:
Protocol Section:
NCT02491892