A Study of Limited Heart Monitoring During Non-anthracycline Trastuzumab-based Therapy in Breast Cancer Patients

A Safety and Feasibility Study of Limited Cardiac Monitoring During Non-anthracycline Trastuzumab-based Therapy in Patients With HER2-positive Breast Cancer

The purpose of this study is to test whether patients with breast cancer who are being treated with non-anthracycline trastuzumab therapy can safely be monitored for heart related side effects less often than usual.

Inclusion Criteria:

• Age >/= 18 years
• Newly diagnosed histologically confirmed primary invasive breast carcinoma (Stage I-IV)
• Pathologically confirmed HER2-positive breast cancer
• Planned to receive trastuzumab-based therapy for a minimum of 12 months, or started trastuzumab-based therapy within the last weeks with a planned duration of at least 12 months.
• Normal LV systolic function (EF greater than or equal to the institutional lower limit of normal)
• William and able to comply with the requirements of the protocol

Exclusion Criteria:

• Planned to receive an anthracycline-based regimen
• Prior history of treatment with anthracycline chemotherapy
• History of cardiovascular including cardiomyopathy, heart failure, or any other clinically significant cardiovascular disease (as determined by the investigator)
• Uncontrolled hypertension, defined as systolic blood pressure >/= 160 mmHg and/or diastolic blood pressure >/= 90 mmHg (as determined by the investigator)