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

Samsung Medical Center

Status: Unknown

Conditions: Cardiotoxicity; Prevention; Breast Cancer; Adjuvant; Trastuzumab

Treatments: Drug: Candesartan

Study type: Interventional

Funder types: Other

Identifiers

NCT04429633

2018-11-128

Details and patient eligibility

About

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.

Full 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.

Enrollment: 136 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

Conventional Cardiac intervention

Active Comparator group

Description:

Starting candesartan in patients with left ventricular ejection fraction (LVEF) between 45% and 50% by echocardiogram.

Treatment:

Drug: Candesartan

Early Cardiac intervention

Active Comparator group

Description:

Starting candesartan in patients with decreased myocardial strain below 18% regardless of LVEF by echocardiogram.

Treatment:

Drug: Candesartan