This pilot phase II trial studies the side effects of trastuzumab, pertuzumab, or trastuzumab emtansine in treating patients with HER2 positive stage I-IV breast cancer. Monoclonal antibodies, such as trastuzumab, pertuzumab, or trastuzumab emtansine, may interfere with the ability of tumor cells to grow and spread.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01904903.
PRIMARY OBJECTIVES:
I. To evaluate the cardiac safety of HER2 targeted therapy (non-lapatinib) in patients with HER2 positive breast cancer and reduced left ventricular ejection fraction (LVEF) when given concomitantly with cardiac treatment.
SECONDARY OBJECTIVES:
I. To evaluate time to development of cardiac events or asymptomatic worsening of cardiac function.
II. To evaluate absolute changes in LVEF.
III. To evaluate delays in HER2 therapy attributed to cardiac causes.
IV. To evaluate correlations between echocardiographic myocardial strain, cardiac troponin I (cTnI) and highly sensitive cardiac troponin T (hs-cTnT) at baseline and over time with cardiac events and asymptomatic worsening of cardiac function.
OUTLINE:
Patients receive trastuzumab intravenously (IV) over 30-90 minutes on day 1, pertuzumab IV over 30-60 minutes on day 1, or trastuzumab emtansine IV over 30-90 minutes on day 1 at the discretion of the treating oncologist. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 6 months or 5 years (optional).
Lead OrganizationMedStar Washington Hospital Center
Principal InvestigatorSandra Meta Swain
