Status:
COMPLETED
Cardiac Safety Study in Patients With HER2 + Breast Cancer
Lead Sponsor:
Medstar Health Research Institute
Collaborating Sponsors:
Genentech, Inc.
Conditions:
HER2 Positive Breast Cancer
Left Ventricular Function Systolic Dysfunction
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
HER2 positive breast cancer cells have more HER2 receptor (a protein on the surface of cells) than normal breast cells. Approximately 30% of patients with breast cancer have HER2 positive breast cance...
Detailed Description
Title: A pilot study evaluating the cardiac safety of HER2 targeted therapy (non-lapatinib) in patients with HER2 positive breast cancer and reduced left ventricular function Phase: Pilot study Study ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2020
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01904903
Start Date
October 1 2013
End Date
June 1 2020
Last Update
May 10 2022
Active Locations (2)
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1
Washington Cancer Institute at MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
2
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20057