Cardiovascular HealthJUSTIFYNCT06930521
JUdicious Surveillance for Trastuzumab Induced Cardiotoxicity in the First Year
A study testing Intervention - Low Risk Group OR Intermediate Risk Group in people with Cardiovascular Health and Breast Cancer, run by Women's College Hospital at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Cardiovascular Health, Breast Cancer, Breast Cancer Early Stage Breast Cancer (Stage 1-3)
- What is being tested?
- Intervention - Low Risk Group OR Intermediate Risk Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- 22 Apr 2026to Jun 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage 1-3 breast cancer (BC).
- Age 18-79 years.
- HER-2 positive BC with planned HER2 targeted therapy (HER2TT) for curative intent.
Who cannot join
- 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%
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Priyancee Sabhaya, MSc, 437-522-6441, Priyancee.Sabhaya2@uhn.ca
Husam Abdel-Qadir, MD, PhD
About this study
Official title: 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.
Read more
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.
- Conditions
- Cardiovascular Health, Breast Cancer, Breast Cancer Early Stage Breast Cancer (Stage 1-3), Cardio-oncology, Circulatory and Respiratory Health, Clinical and Translational Cardiovascular Sciences
- Being tested
- Intervention - Low Risk Group OR Intermediate Risk Group
- Keywords
- Trastuzumab, Cardiac imaging, Her-2 positive breast cancer, Echocardiography, Cardiotoxicity, Left ventricular ejection fraction, Heart failure, Randomized controlled trial, Nuclear imaging, Non-inferiority
- Medical subject headings
- Breast Neoplasms, Cardiotoxicity, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention - Low Risk Group OR Intermediate Risk GroupDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No 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. |
| Judicious Imaging | Experimental | 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. Receives: Diagnostic Test: Intervention - Low Risk Group OR Intermediate Risk Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically overt heart failure
Determined as a binary event Y/N, per standardized definition
Measured: From enrollment to <100days after end of treatment
Premature HER2TT discontinuation
Determined as a binary event Y/N, per clinical records
Measured: From enrollment to <100days after end of treatment
Patient-reported outcome measures (PROMS) of anxiety/depression, stress, and treatment burden
Desirable outcome is a better scores in ≥2 of 3 PROMs-Treatment Burden Questionnaire, Hospital Anxiety and Depression Scale, Perceived Stress Scale
Measured: From enrollment to <100 days after end of treatment
Asymptomatic cardiotoxicity at end of HER2TT
Per Cardiac Review and Evaluation Committee criteria, based on LVEF change
Measured: From enrollment to <100 days after the end of treatment
Time to complete HER2TT
Number weeks from first HER2TT cycle to last (shorter is better)
Measured: From enrollment to <100 days after the end of treatment
Total number of cardiac imaging tests during HER2TT
Number of LVEF assessments (fewer is better)
Measured: From enrollment to <100 days after the end of treatment
Secondary outcomes (2)
Absolute change in percentage of LVEF
Based on cardiac imaging. Analyzed for non-inferiority of judicious imaging versus standard of care
Measured: From baseline imaging to one year
Desirability Ratio
Limited to primary outcomes 1-5 (excluding the number of cardiac imaging tests)
Measured: From enrollment to <100 days after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start22 Apr 2026
- Primary completionJun 2029 (estimated)
- Study completionJun 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to one of two groups with regards to the frequency of mandatory echocardiograms: Group 1 - Standard of Care Group: Participants in this group will receive imaging before cycles 1, 5, 9, and 13 of trastuzumab (or every 3 months) and another echocardiogram after completion of trastuzumab (within 100 days after completion of HER2TT). Group 2 - Judicious Imaging Group: 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto
- Responsible party
- Principal investigator, Husam Abdel-Qadir, Women's College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06930521
- Sponsor's protocol ID
- 5034
- Acronym
- JUSTIFY
- Status last verified
- Jun 2026
- First submitted
- 31 Mar 2025
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- JUdicious Surveillance for Trastuzumab Induced Cardiotoxicity in the First Year (JUSTIFY): a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06930521
- Acronym / sponsor ID
- JUSTIFY / 5034
- Conditions
- Cardiovascular Health, Breast Cancer, Breast Cancer Early Stage Breast Cancer (Stage 1-3), Cardio-oncology, Circulatory and Respiratory Health, Clinical and Translational Cardiovascular Sciences
- Keywords
- Trastuzumab, Cardiac imaging, Her-2 positive breast cancer, Echocardiography, Cardiotoxicity, Left ventricular ejection fraction, Heart failure, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Collaborators
- University Health Network, Toronto
- Study start
- 22 Apr 2026 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2033 (estimated)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to one of two groups with regards to the frequency of mandatory echocardiograms: Group 1 - Standard of Care Group: Participants in this group will receive imaging before cycles 1, 5, 9, and 13 of trastuzumab (or every 3 months) and another echocardiogram after completion of trastuzumab (within 100 days after completion of HER2TT). Group 2 - Judicious Imaging Group: 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.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No 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. |
| Judicious Imaging | Experimental | Diagnostic Test: Intervention - Low Risk Group OR Intermediate Risk GroupThis 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. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stage 1-3 breast cancer (BC).
- Age 18-79 years.
- HER-2 positive BC with planned HER2 targeted therapy (HER2TT) for curative intent.
Key exclusion criteria (11 listed)
- 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:
- 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*
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention - Low Risk Group OR Intermediate Risk GroupParticipants 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. | Diagnostic test | Judicious Imaging |
Primary outcome
Clinically overt heart failure
Time frame: From enrollment to <100days after end of treatment
Determined as a binary event Y/N, per standardized definition
Premature HER2TT discontinuation
Time frame: From enrollment to <100days after end of treatment
Determined as a binary event Y/N, per clinical records
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
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
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)
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)
2 secondary outcomes
Absolute change in percentage of LVEF
Time frame: From baseline imaging to one year
Desirability Ratio
Time frame: From enrollment to <100 days after the end of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention - Low Risk Group OR Intermediate Risk Group in people with Cardiovascular Health and Breast Cancer, run by Women's College Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Husam Abdel-Qadir, MD, PhD, FRCPC (416-323-7723, husam.abdel-qadir@wchospital.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically overt heart failure (time frame: From enrollment to <100days after end of treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.