NCT03983382
Active, not recruiting
Not Applicable
A Safety and Feasibility Study of Limited Cardiac Monitoring During Non-anthracycline Trastuzumab-based Therapy in Patients With HER2-positive Breast Cancer
ConditionsBreast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 190
- Locations
- 8
- Primary Endpoint
- Frequency of Cardiac Adverse Events, Defined by a Compositive of Clinical Heart Failure (NYHA Class III or IV) or Cardiac Death.
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Frequency of Cardiac Adverse Events, Defined by a Compositive of Clinical Heart Failure (NYHA Class III or IV) or Cardiac Death.
Time Frame: 12 months from baseline
Study Sites (8)
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