Strain vs. Left Ventricular Ejection Fraction-based Cardiotoxicity Prevention in Breast Cancer

  • STATUS
    Recruiting
  • participants needed
    136
  • sponsor
    Samsung Medical Center
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Updated on 19 February 2024
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cancer
strain
breast cancer
ejection fraction
trastuzumab
anthracyclines
immunomodulators
cardiotoxicity
angiotensin
her2/neu-positive breast cancer
immunostimulant
anthracycline
her2-positive breast cancer
adjuvant
HER2
her2+ breast cancer

Summary

Comparing preventive effect of myocardial global longitudinal strain-based cardioprotective stragety (angiotensin receptor blocker prophylaxis) with left ventricular ejection fraction-based strategy in breast cancer patients treated with adjuvant trastuzumab.

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 evaluation and treatment strategies. Therefore, we aimed to evaluate the effect of early intervention strategy (GLS-based cardiotoxicity monitoring and administration of candesartan) by comparing with conventional intervention strategy (left ventricular ejection fraction-based cardiotoxicity monitoring and administration of candesartan) in breast cancer patients who treated with adjuvant trastuzumab.

Details
Condition prevention & control, Breast Cancer, Breast Cancer, Immunostimulant, Pharmaceutical Adjuvants, Breast Cancer - HER2 Positive, Chronic Shoulder Pain, Trastuzumab
Age 18years - 100years
Treatment Candesartan
Clinical Study IdentifierNCT04429633
SponsorSamsung Medical Center
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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cancer
strain
breast cancer
ejection fraction
trastuzumab
anthracyclines
immunomodulators
cardiotoxicity
angiotensin
her2/neu-positive breast cancer
immunostimulant
anthracycline
her2-positive breast cancer
adjuvant
HER2
her2+ breast cancer

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