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

Not Applicable

• Conditions: Cardiotoxicity; Breast Cancer; Adjuvant; Trastuzumab; Prevention
• Interventions: Drug: Candesartan

• Registration Number: NCT04429633
• Lead Sponsor: Samsung Medical Center

Brief 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.

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 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.

Study Timeline

• Study Start: 2019-07-19
• Status Verified: 2020-06
• Study First Submitted: 2020-06-10
• Study First Submitted QC: 2020-06-10
• Last Update Submitted: 2020-06-10
• Study First Posted: 2020-06-12
• Last Update Posted: 2020-06-12
• Primary Completion: 2022-07-18
• Study Completion: 2023-07-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 136

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Cardiac intervention	Candesartan	Starting candesartan in patients with left ventricular ejection fraction (LVEF) between 45% and 50% by echocardiogram.
Early Cardiac intervention	Candesartan	Starting candesartan in patients with decreased myocardial strain below 18% regardless of LVEF by echocardiogram.

Primary Outcome Measures

Name	Time	Method
Left ventricular ejection fraction (LVEF)	at months 3,6,9,12,18	Maximum change in LVEF

Secondary Outcome Measures

Name	Time	Method
Overt chemotherapy induced cardiotoxicity	any time	LVEF \< 45%, decline in LVEF by \>10% to a value to 45-49%, symptomatic congestive heart failure
Changes in cardiac biomarker	at months 3,6,9,12,18	NT-pro BNP, cardiac troponin

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of