Surveillance for Cardiotoxicity from Trastuzumab in Breast Cancer

(JUSTIFY Trial)

Overseen By Husam Abdel-Qadir, MD, PhD, FRCPC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Women's College Hospital

Must be taking: HER2 targeted therapy

Disqualifiers: Metastases, Cardiovascular disease, Anthracyclines, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 48 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if fewer heart tests can be safely used during treatment for breast cancer positive for the HER2 receptor. Current guidelines require heart tests every three months, but the study will assess if some patients can have fewer tests based on their risk of heart problems. Participants will be divided into groups, with low-risk patients receiving tests every six months and intermediate-risk patients every four months. The trial seeks to demonstrate that less frequent testing can maintain patient safety while reducing stress and healthcare costs. Individuals with Stage 1-3 HER2 positive breast cancer planning to receive targeted therapy with trastuzumab might be suitable for this study. As an unphased trial, this study offers patients the chance to contribute to research that could simplify and improve future care practices.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on monitoring heart health during cancer treatment.

What prior data suggests that this new cardiac surveillance approach is safe for patients with HER2 positive breast cancer?

Research has shown that patients with a low risk of heart problems can safely undergo heart tests every 6 months instead of every 3 months during HER2-targeted breast cancer treatment. Studies have found that this adjustment does not increase heart issues. Treatments such as Trastuzumab, commonly used in these therapies, are generally well-tolerated and do not cause significant heart-related side effects. Thus, for patients with a lower risk of heart problems, fewer heart tests can maintain safety without compromising the quality of care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a more personalized approach to monitoring heart health in breast cancer patients treated with trastuzumab. Unlike the standard practice of frequent imaging every three months, this trial tests a more tailored schedule based on individual risk. Low-risk patients may only need heart imaging every six months, while those at intermediate risk might have it every four months. This could reduce unnecessary procedures and minimize patient stress, all while still effectively watching for any potential heart issues.

What evidence suggests that this new cardiac surveillance approach is effective for HER2 positive breast cancer patients?

Research has shown that trastuzumab effectively treats HER2-positive breast cancer, but it can sometimes cause heart-related side effects. In this trial, participants will be divided into two groups to monitor heart health. The Standard of Care group will receive imaging every three months, following the FDA product label. Meanwhile, the Judicious Imaging group will have fewer echocardiograms based on their risk of developing heart failure. One study found that checking the heart every six months, instead of every three months, did not increase the risk of heart problems during treatment. Another study found that using a risk-based approach, where individuals at lower risk had fewer heart tests, was safe and did not affect cancer treatment results. These findings suggest that fewer heart tests could be just as effective while reducing stress and costs for patients. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for male and female patients with HER2 positive breast cancer. It's designed to test a new approach to monitoring heart health during cancer treatment, which can sometimes harm the heart. Patients will be categorized into low or intermediate risk groups for cardiotoxicity.

Inclusion Criteria

My breast cancer is at stage 1, 2, or 3.

My breast cancer is HER2 positive and I plan to undergo HER2 targeted therapy.

Exclusion Criteria

Baseline echocardiogram images of insufficient quality for a quantitative assessment of left ventricular ejection fraction (LVEF)

My cancer has spread to distant parts of my body.

I have a history of heart problems including a heart attack, heart failure, low heart pump function, irregular heartbeat, or significant valve issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive HER2-targeted therapy with cardiac imaging every 3 months for standard care or every 4-6 months for judicious imaging based on risk

48 weeks

Imaging every 3 months (standard care) or every 4-6 months (judicious imaging)

Follow-up

Participants are monitored for heart health, treatment completion, and patient well-being after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Intervention - Low Risk Group OR Intermediate Risk Group

Trial Overview The study is testing whether fewer heart tests are as safe and effective as the current standard of every three months. Low-risk patients will have tests every six months, while intermediate-risk ones will have them every four months. The outcomes on heart health, treatment completion, and patient satisfaction will be compared.

How Is the Trial Designed?

Group I: Judicious Imaging Experimental Treatment 1 Intervention

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.

Group II: Standard of Care Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Women's College Hospital

Lead Sponsor

Trials

108

Recruited

43,700+

University Health Network, Toronto

Collaborator

Trials

1,555

Recruited

526,000+

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06930521/judicious-surveillance-for-trastuzumab-induced-cardiotoxicity-in-the-first-year

JUdicious Surveillance for Trastuzumab Induced ... This study focuses on male and female patients being treated for breast cancer that is positive for the HER2 receptor which requires special ...

2. withpower.com withpower.com/trial/surveillance-for-cardiotoxicity-from-trastuzumab-in-breast-cancer-5f177

Surveillance for Cardiotoxicity from Trastuzumab in Breast ... The research highlights that trastuzumab is effective for treating HER2-positive breast cancer, but it can cause heart-related side effects. Monitoring heart ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666087325000183

Risk Stratification for Trastuzumab-Induced Cardiac ... The aim of this study was to examine the incidence of trastuzumab-associated CTRCD in a contemporary cohort with HER2-positive breast cancer.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12228139/

Cardiac Safety of Reduced Cardiotoxicity Surveillance During ... This study evaluated the cardiac safety of reduced CTRCD surveillance performed every 6 months during non-anthracycline HER2-targeted treatment.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06930521

Study Details | NCT06930521 | JUdicious Surveillance for ... This study focuses on male and female patients being treated for breast cancer that is positive for the HER2 receptor which requires special treatments ...

6. jacc.org jacc.org/doi/10.1016/j.jaccao.2025.05.006

Cardiac Safety of Reduced Cardiotoxicity Surveillance ... This study evaluated the cardiac safety of reduced CTRCD surveillance performed every 6 months during non-anthracycline HER2-targeted treatment.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40537192/

Cardiac Safety of Reduced Cardiotoxicity Surveillance ... Conclusions: Reduced CTRCD surveillance every 6 months is safe and feasible for patients at low risk for CTRCD and may be an appropriate strategy to consider ...

8. cardiooncologyjournal.biomedcentral.com cardiooncologyjournal.biomedcentral.com/articles/10.1186/s40959-025-00376-9

Cardiac function surveillance practices and outcomes in ... Guidelines recommend cardiac surveillance prior to anti-HER2 therapy initiation, every 3 months during therapy, and within 1 year after therapy ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2666087325001577

Cardiac Safety of Reduced Cardiotoxicity Surveillance ... This study evaluated the cardiac safety of reduced CTRCD surveillance performed every 6 months during non-anthracycline HER2-targeted treatment.

10. nature.com nature.com/articles/s41598-022-18342-1

Cardiac safety analysis of anti-HER2-targeted therapy in ... The anti-HER2 targeted therapy for early breast cancer was well tolerated. Trastuzumab combined with pertuzumab did not significantly increase cardiotoxicity.