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

  • STATUS
    Recruiting
  • End date
    Jul 18, 2023
  • participants needed
    136
  • sponsor
    Samsung Medical Center
Updated on 25 January 2021
cancer
ejection fraction
breast cancer
angiotensin
anthracyclines
strain
HER2
trastuzumab
erbb2
her2/neu-positive breast cancer
immunostimulant

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, Diet and Nutrition, Chronic Diarrhea, Skin Wounds, Chronic Shoulder Pain, Vaginal Atrophy, Adverse Effects, Drugs, Injection Port, Breast Cancer - HER2 Positive, Anal Dysplasia, Primary Immunodeficiency, Pediatric Health, Near-Sighted Corrective Surgery, Cardiotoxicity, Peripheral Arterial Occlusive Disease, Breast Cancer Diagnosis, Brain Function, Cardiac Toxicity, Recurrent Respiratory Papillomatosis, Razor Bumps (Pseudofolliculitis Barbae), Metastatic Triple-Negative Breast Cancer, Trastuzumab, breast carcinoma, immunomodulator, immunostimulants, immunomodulators, immunological adjuvant, immunologic adjuvant, cancer, breast, prophylaxis, preventive treatment, prophylactic treatment
Treatment Candesartan
Clinical Study IdentifierNCT04429633
SponsorSamsung Medical Center
Last Modified on25 January 2021

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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