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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Active, not recruiting

Conditions: Breast Cancer

Treatments: Diagnostic Test: Left Ventricular Ejection Fraction

Study type: Observational

Funder types: Other

Identifiers

NCT03983382

19-045

Details and patient eligibility

About

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.

Enrollment: 190 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

190 participants in 1 patient group

HER2-Positive Breast Cancer

Treatment:

Diagnostic Test: Left Ventricular Ejection Fraction