Clinical trial NCT06930521: JUdicious Surveillance for Trastuzumab Induced Cardiotoxicity in the First Year
Official title: JUdicious Surveillance for Trastuzumab Induced Cardiotoxicity in the First Year (JUSTIFY): a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Health Services and Systems - Healthcare Effectiveness &Amp; Outcomes
Keywords: Trastuzumab
Cardiac imaging
Her-2 positive breast cancer
Echocardiography
Cardiotoxicity
Left ventricular ejection fraction
Heart failure
Randomized controlled trial
Nuclear imaging
Non-inferiority
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
Collaborators: name: University Health Network, Toronto
First posted: 2025-04-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SCREENING

Brief 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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Hierarchical composite endpoint encompassing heart health, patient well-being, treatment completion, and imaging frequency in combination, while assessing priority to more important measures.
timeFrame: From enrollment to the end of treatment at 48 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
Study officials:
References: