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

NCT04429633 | Unknown

• 1 other identifier: 2018-11-128
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiotoxicity; Breast Cancer; Prevention; Adjuvant; Trastuzumab

Outcome Measures

Primary Outcomes (1)

• Left ventricular ejection fraction (LVEF)

  Maximum change in LVEF

  at months 3,6,9,12,18

Secondary Outcomes (2)

• Overt chemotherapy induced cardiotoxicity

  any time

• Changes in cardiac biomarker

  at months 3,6,9,12,18

Study Arms (2)

Conventional Cardiac intervention

ACTIVE COMPARATOR

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

Drug: Candesartan

Early Cardiac intervention

ACTIVE COMPARATOR

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

Drug: Candesartan

Interventions

Candesartan DRUG

If GLS decreased less than 18% or LVEF decreased to 45-50% during the treatment of adjuvant trastuzumab, start candesartan medication.

Conventional Cardiac intervention; Early Cardiac intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Cardiotoxicity; Breast Neoplasms

Interventions

candesartan

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Yeon Hee Park, MD, PhD

CONTACT

+82-2-3410-3450; yeonh.park@samsung.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 12, 2020
• Study Start: July 19, 2019
• Primary Completion: July 18, 2022
• Study Completion: July 18, 2023
• Last Updated: June 12, 2020

Record last verified: 2020-06

Locations

KR (1)