NCT06930521Recruiting
JUdicious Surveillance for Trastuzumab Induced Cardiotoxicity in the First Year
JUdicious Surveillance for Trastuzumab Induced Cardiotoxicity in the First Year (JUSTIFY): a Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 15 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 31 Mar 2025
- Start date
- 22 Apr 2026
- Primary completion date
- Jun 2029
- Lead sponsor
- Women's College Hospital
- Diseases
- Heart failure
- NCT number
- NCT06930521
What you commit to
- Study type: Interventional
- Planned participants: 300
- From 22 Apr 2026 to the primary completion date, Jun 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Lab values
- 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)
Other
- Distant metastases detected clinically, radiographically, or histologically
- Cumulative anthracycline exposure ≥250mg/m2 before starting HER2TT
Who the study is looking for
- Stage 1-3 breast cancer (BC).
- Age 18-79 years.
- HER-2 positive BC with planned HER2 targeted therapy (HER2TT) for curative intent.
Age in the registry: 18 years to 79 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Toronto General Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.