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 @ 7:47 PM
Ignite Modification Date:
2025-12-24 @ 7:47 PM
NCT ID:
NCT01904903
Eligibility Criteria:
Inclusion Criteria:
* Female or male patient diagnosed with stage I-IV breast cancer
* HER2 positive breast cancer, defined by immunohistochemical staining for HER2 protein of 3+ intensity and/or amplification of the HER2 gene on fluorescence in situ hybridization (FISH) ≥ 2.0 on breast specimen or biopsy of a metastatic site
* LVEF \< 50% and ≥ 40% documented in echocardiogram done within the last 30 days
* HER2 therapy naïve or currently receiving non-lapatinib HER2 targeted therapy
* Patient receiving or planning to receive trastuzumab, trastuzumab with pertuzumab or ado-trastuzumab emtansine, for at least 3 months, alone or in combination with other systemic treatment or radiation
* Age ≥ 18 years
* Patient is willing and able to comply with protocol required assessments and procedures
Exclusion Criteria:
* Previous hospitalization due to documented heart failure in the last 12 months
* Current signs or symptoms of heart failure or ischemia
* History of arrhythmia requiring pharmacological or electrical treatment
* Concomitant use of anthracyclines or use of anthracyclines in the last 50 days
* Pregnant or lactating patients. Patients of childbearing potential must implement contraceptive measures during study treatment and for 7 months after last dose of treatment drug and must have negative urine or serum pregnancy test within 7 days prior to registration.
* History of significant neurologic or psychiatric disorders including psychotic disorders or dementia that would prohibit the understanding and giving of informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT01904903
Study Brief:
Protocol Section:
NCT01904903