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NCT Number: NCT06930521

JUdicious Surveillance for Trastuzumab Induced Cardiotoxicity in the First Year

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.

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Key information

Conditions

Cardiovascular Health Breast Cancer Breast Cancer Early Stage Breast Cancer (Stage 1-3) Breast Diseases Breast Neoplasms Cardio-oncology Cardiotoxicity Cardiovascular Diseases Chemically-Induced Disorders Circulatory and Respiratory Health Clinical and Translational Cardiovascular Sciences Drug-Related Side Effects and Adverse Reactions Health Services and Systems - Healthcare Effectiveness &Amp; Outcomes Heart Diseases Heart Failure Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Injuries Skin Diseases Skin and Connective Tissue Diseases Wounds and Injuries

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location status: Recruiting

Location contact

Husam Abdel-Qadir, MD, PhD

PRINCIPAL_INVESTIGATOR

Priyancee Sabhaya, MSc

CONTACT

[email protected]

437-522-6441

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Distant metastases detected clinically, radiographically, or histologically
  • Baseline echocardiogram images of insufficient quality for a quantitative assessment of left ventricular ejection fraction (LVEF)
  • Pre-existing cardiovascular disease, defined as:
  • Prior myocardial infarction (even if LVEF has normalized)
  • Prior heart failure (HF, including patients with preserved ejection fraction and normalized LVEF)
  • Baseline LVEF <55%
  • Atrial fibrillation
  • Greater than moderate valvular disease (i.e., severe, or moderate-severe)
  • Cumulative anthracycline exposure ≥250mg/m2 before starting HER2TT
  • New York Heart Association Functional Class II, III or IV, or Eastern Cooperative Oncology Group score >2*
  • 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.

Treatment and study plan

Intervention - Low Risk Group OR Intermediate Risk Group

Diagnostic Test

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.

Primary outcomes

  1. Clinically overt heart failure

    Time frame: From enrollment to <100days after end of treatment

    Determined as a binary event Y/N, per standardized definition

  2. Premature HER2TT discontinuation

    Time frame: From enrollment to <100days after end of treatment

    Determined as a binary event Y/N, per clinical records

  3. 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

  4. 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

  5. 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)

  6. 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)

Secondary outcomes

  1. 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

  2. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Husam Abdel-Qadir, MD, PhD, FRCPC

CONTACT

[email protected]

416-323-7723

Sponsors and collaborators

Lead sponsor

Women's College Hospital

Other

Collaborators

  • University Health Network, Toronto

Registry information

Official study title

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

Acronym: JUSTIFY

Important dates

Study start
2026
Primary completion
2029
Study completion
2033
First posted
Apr 16, 2025
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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