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

Breast Cancer Clinical Trial

Official title:

Strain-based vs. Left Ventricular Ejection Fraction-based Cardiotoxicity Prevention Strategy in Patients With Breast Cancer Who Treated With Adjuvant Trastuzumab

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04429633
• Other study ID #: 2018-11-128
• Status: Recruiting
• Phase: N/A
• Start date: July 19, 2019
• Est. completion date: July 18, 2023

Study information

• Verified date: June 2020
• Source: Samsung Medical Center
• Contact: Yeon Hee Park, MD, PhD
• Phone: +82-2-3410-3450
• Email: yeonh.park[@]samsung.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 136
• Est. completion date: July 18, 2023
• Est. primary completion date: July 18, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adjuvant
• Breast Cancer
• Breast Neoplasms
• Cardiotoxicity
• Prevention
• Trastuzumab

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular ejection fraction (LVEF)	Maximum change in LVEF	at months 3,6,9,12,18
Secondary	Overt chemotherapy induced cardiotoxicity	LVEF < 45%, decline in LVEF by >10% to a value to 45-49%, symptomatic congestive heart failure	any time
Secondary	Changes in cardiac biomarker	NT-pro BNP, cardiac troponin	at months 3,6,9,12,18