Status:
UNKNOWN
Strain vs. Left Ventricular Ejection Fraction-based Cardiotoxicity Prevention in Breast Cancer
Lead Sponsor:
Samsung Medical Center
Conditions:
Cardiotoxicity
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Comparing preventive effect of myocardial global longitudinal strain-based cardioprotective stragety (angiotensin receptor blocker prophylaxis) with left ventricular ejection fraction-based strategy i...
Detailed Description
Despite the left ventricular global longitudinal strain (GLS) enables early prediction of trastuzumab-related cardiomyopathy, its clinical application has been hampered due to the lack of appropriate ...
Eligibility Criteria
Inclusion
- Female aged ≥ 18 years
- Pathologically confirmed HER2-positive breast cancer
- Adjuvant treatment plan comprises at least 12 cycles of Trastuzumab
- Baseline echocardiogram should be performed before starting trastuzumab
- Cumulative anthracycline dose ≤ 300mg/m2
- Written informed consent to participate in the study
Exclusion
- History of hypersensitivity or alllergic reaction to the study medication
- Metastatic breast cancer
- Treatment with angiotensin converting enzyme(ACE) inhibitor , Angiotensin receptor blocker (ARB), beta-blocking agents, or diuretics
- Patients with NCI/CTCAE grade ≥ 2 congestive heart failure, myocardial infarction, symptomatic left ventricular systolic dysfunction, heart's valve disease (≥ moderate), arrhythmias (Grade ≥ 3) \< 12 months before enrollment
- Pregnancy or breast feeding
- Baseline systolic pressure \< 90mmHg
- Cumulative anthracycline dose \> 300mg/m2
- Serious concurrent illness
Key Trial Info
Start Date :
July 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 18 2023
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT04429633
Start Date
July 19 2019
End Date
July 18 2023
Last Update
June 12 2020
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea, 06351