Strain vs. Left Ventricular Ejection Fraction-based Cardiotoxicity Prevention in Breast Cancer
NCT ID: NCT04429633
Last Updated: 2020-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
136 participants
INTERVENTIONAL
2019-07-19
2023-07-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Conventional Cardiac intervention
Starting candesartan in patients with left ventricular ejection fraction (LVEF) between 45% and 50% by echocardiogram.
Candesartan
If GLS decreased less than 18% or LVEF decreased to 45-50% during the treatment of adjuvant trastuzumab, start candesartan medication.
Early Cardiac intervention
Starting candesartan in patients with decreased myocardial strain below 18% regardless of LVEF by echocardiogram.
Candesartan
If GLS decreased less than 18% or LVEF decreased to 45-50% during the treatment of adjuvant trastuzumab, start candesartan medication.
Interventions
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Candesartan
If GLS decreased less than 18% or LVEF decreased to 45-50% during the treatment of adjuvant trastuzumab, start candesartan medication.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Yeon Hee Park
Professor, MD, PhD
Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2018-11-128
Identifier Type: -
Identifier Source: org_study_id
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