JUdicious Surveillance for Trastuzumab Induced Cardiotoxicity in the First Year (JUSTIFY)

June 11, 2026 updated by: Husam Abdel-Qadir, Women's College Hospital

JUdicious Surveillance for Trastuzumab Induced Cardiotoxicity in the First Year (JUSTIFY): a Randomized Controlled Trial

This study focuses on male and female patients being treated for breast cancer that is positive for the HER2 receptor which requires special treatments targeting that receptor. The problem is that these treatments, while effective for the cancer, can sometimes harm the heart. Because of this, patients have to undergo heart tests every three months during treatment, even if they have no history of heart disease or feel fine.

The guidelines for these regular heart tests were established decades ago when these treatments were first introduced, but research shows that most of these tests don't actually change the treatment plan. This suggests that many patients are going through unnecessary tests, which can cause stress, delay treatments, and increase healthcare costs.

To address this, the researchers propose a new study with 300 patients with HER2 positive breast cancer to test a more personalized approach to cardiac surveillance. Participants will be classified based on their risk of heart problems: low or intermediate. Instead of testing every patient every three months, those in the intermediate group will be tested every 4 months, and those in the low-risk group will be tested every 6 months. The researchers will compare this new approach to the current system to see if fewer tests are just as safe and effective.

The researchers will measure heart health, how well cancer treatments are completed, and how patients feel about having fewer tests. If this new approach works, it could save money and reduce the burden on female patients without risking their health.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Recruiting
        • Toronto General Hospital
        • Contact:
        • Principal Investigator:
          • Husam Abdel-Qadir, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Stage 1-3 breast cancer (BC).
  2. Age 18-79 years.
  3. HER-2 positive BC with planned HER2 targeted therapy (HER2TT) for curative intent.

Exclusion Criteria:

  1. Distant metastases detected clinically, radiographically, or histologically
  2. Baseline echocardiogram images of insufficient quality for a quantitative assessment of left ventricular ejection fraction (LVEF)

  3. Pre-existing cardiovascular disease, defined as:

    1. Prior myocardial infarction (even if LVEF has normalized)
    2. Prior heart failure (HF, including patients with preserved ejection fraction and normalized LVEF)
    3. Baseline LVEF <55%
    4. Atrial fibrillation
    5. Greater than moderate valvular disease (i.e., severe, or moderate-severe)
  4. Cumulative anthracycline exposure ≥250mg/m2 before starting HER2TT
  5. New York Heart Association Functional Class II, III or IV, or Eastern Cooperative Oncology Group score >2*
  6. Symptoms potentially due to serious cardiac disease as per investigator's judgement* *Exclusion criterion adopted as they make clinical assessment less reliable to detect emergent HF.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of Care
The SOC arm will receive imaging before cycles 1, 5, 9, and 13 (in keeping with the FDA product label), then at the end of HER2-TT, i.e., imaging every 3 months for uninterrupted adjuvant HER2TT.
Experimental: Judicious Imaging
This group will get less echocardiograms based on their risk of developing heart failure. People who do not have any issues that predispose to heart failure are categorized as low risk and will get an echocardiogram once every 6 months. People who have factors that may predispose to heart failure are categorized as intermediate risk and will get an echocardiogram approximately once every 4 months.
Diagnostic test: Intervention - Low Risk Group OR Intermediate Risk Group

Participants will be randomized to judicious imaging (decreased imaging frequency based on HF risk category) or SOC (imaging every 3 months). Participants who do not have any HF risk factors will be categorized as low risk, while participants with at least one risk factor will be categorized as intermediate risk for HF.

Low Risk (zero risk factors): imaging before cycles 1 and 9 of HER2-TT (i.e., at baseline and near the halfway mark, corresponding to 2 fewer studies than SOC in Year 1), then after the end of HER2TT. This translates to imaging every 6 months for uninterrupted adjuvant HER2TT.

Intermediate Risk (any risk factors): imaging before cycles 1, 6, and 12 of HER2-TT (i.e., at baseline and near the 1/3 and 2/3 marks, corresponding to 1 fewer study than SOC in Year 1), then at end of HER2TT. This translates to imaging every 4 months for uninterrupted adjuvant HER2TT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinically overt heart failure
Time Frame: From enrollment to <100days after end of treatment
Determined as a binary event Y/N, per standardized definition
From enrollment to <100days after end of treatment
Premature HER2TT discontinuation
Time Frame: From enrollment to <100days after end of treatment
Determined as a binary event Y/N, per clinical records
From enrollment to <100days after end of treatment
Patient-reported outcome measures (PROMS) of anxiety/depression, stress, and treatment burden
Time Frame: From enrollment to <100 days after end of treatment
Desirable outcome is a better scores in ≥2 of 3 PROMs-Treatment Burden Questionnaire, Hospital Anxiety and Depression Scale, Perceived Stress Scale
From enrollment to <100 days after end of treatment
Asymptomatic cardiotoxicity at end of HER2TT
Time Frame: From enrollment to <100 days after the end of treatment
Per Cardiac Review and Evaluation Committee criteria, based on LVEF change
From enrollment to <100 days after the end of treatment
Time to complete HER2TT
Time Frame: From enrollment to <100 days after the end of treatment
Number weeks from first HER2TT cycle to last (shorter is better)
From enrollment to <100 days after the end of treatment
Total number of cardiac imaging tests during HER2TT
Time Frame: From enrollment to <100 days after the end of treatment
Number of LVEF assessments (fewer is better)
From enrollment to <100 days after the end of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute change in percentage of LVEF
Time Frame: From baseline imaging to one year
Based on cardiac imaging. Analyzed for non-inferiority of judicious imaging versus standard of care
From baseline imaging to one year
Desirability Ratio
Time Frame: From enrollment to <100 days after the end of treatment
Limited to primary outcomes 1-5 (excluding the number of cardiac imaging tests)
From enrollment to <100 days after the end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Women's College Hospital

Collaborators

University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2026

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2033

Study Registration Dates

First Submitted

March 31, 2025

First Submitted That Met QC Criteria

April 8, 2025

First Posted (Actual)

April 16, 2025

Study Record Updates

Last Update Posted (Actual)

June 15, 2026

Last Update Submitted That Met QC Criteria

June 11, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5034

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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