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

Primary Purpose

Cardiotoxicity, Breast Cancer, Prevention

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Candesartan
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiotoxicity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Conventional Cardiac intervention

Early Cardiac intervention

Arm Description

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

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

Outcomes

Primary Outcome Measures

Left ventricular ejection fraction (LVEF)
Maximum change in LVEF

Secondary Outcome Measures

Overt chemotherapy induced cardiotoxicity
LVEF < 45%, decline in LVEF by >10% to a value to 45-49%, symptomatic congestive heart failure
Changes in cardiac biomarker
NT-pro BNP, cardiac troponin

Full Information

First Posted
June 10, 2020
Last Updated
June 10, 2020
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04429633
Brief Title
Strain vs. Left Ventricular Ejection Fraction-based Cardiotoxicity Prevention in Breast Cancer
Official Title
Strain-based vs. Left Ventricular Ejection Fraction-based Cardiotoxicity Prevention Strategy in Patients With Breast Cancer Who Treated With Adjuvant Trastuzumab
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 19, 2019 (Actual)
Primary Completion Date
July 18, 2022 (Anticipated)
Study Completion Date
July 18, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiotoxicity, Breast Cancer, Prevention, Adjuvant, Trastuzumab

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional Cardiac intervention
Arm Type
Active Comparator
Arm Description
Starting candesartan in patients with left ventricular ejection fraction (LVEF) between 45% and 50% by echocardiogram.
Arm Title
Early Cardiac intervention
Arm Type
Active Comparator
Arm Description
Starting candesartan in patients with decreased myocardial strain below 18% regardless of LVEF by echocardiogram.
Intervention Type
Drug
Intervention Name(s)
Candesartan
Intervention Description
If GLS decreased less than 18% or LVEF decreased to 45-50% during the treatment of adjuvant trastuzumab, start candesartan medication.
Primary Outcome Measure Information:
Title
Left ventricular ejection fraction (LVEF)
Description
Maximum change in LVEF
Time Frame
at months 3,6,9,12,18
Secondary Outcome Measure Information:
Title
Overt chemotherapy induced cardiotoxicity
Description
LVEF < 45%, decline in LVEF by >10% to a value to 45-49%, symptomatic congestive heart failure
Time Frame
any time
Title
Changes in cardiac biomarker
Description
NT-pro BNP, cardiac troponin
Time Frame
at months 3,6,9,12,18

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yeon Hee Park, MD, PhD
Phone
+82-2-3410-3450
Email
yeonh.park@samsung.com
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yeon Hee Park, MD, Ph.D
Phone
+82-2-3410-3459
Email
yeonh.park@samsung.com

12. IPD Sharing Statement

Learn more about this trial

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

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