This trial studies limited heart monitoring in patients with stage I-IV HER2-positive breast cancer treated with the immunotherapy drug trastuzumab, but without a type of chemotherapy called an anthracycline. Patients treated with trastuzumab usually undergo regular heart monitoring about every 3 months to check for side effects on the heart. However, patients treated with non-anthracycline trastuzumab-based therapy are at low risk for developing a heart side effect. This study may help researchers find out if less frequent heart monitoring is safe and more appropriate in patients with breast cancer treated with non-anthracycline trastuzumab-based therapy.
Additional locations may be listed on ClinicalTrials.gov for NCT03983382.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To evaluate the cardiac safety of a limited cardiac monitoring strategy in patients with HER2-positive breast cancer treated with a non-anthracycline trastuzumab-based regimen.
SECONDARY OBJECTIVES:
I. To determine the feasibility of a limited cardiac monitoring strategy.
II. To measure the absolute change in left ventricular ejection fraction (LVEF) at 6 and 12 months after initiation of trastuzumab-based therapy.
III. To measure the absolute change in global longitudinal strain at 6 and 12 months after trastuzumab-based therapy.
IV. To estimate the incidence of trastuzumab-based treatment interruption attributed to cardiac causes.
V. To estimate the cumulative incidence of asymptomatic LVEF decline during trastuzumab-based therapy.
VI. To evaluate health service utilization.
OUTLINE:
Patients undergo an assessment for LVEF at baseline, then at 6 and 12 months after beginning trastuzumab-based therapy.
After completion of study, patients are followed up at 6 months.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorAnthony Francis Yu
