JUdicious Surveillance for Trastuzumab Induced Cardiotoxicity in the First Year

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-79
SponsorWomen's College Hospital

About this 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.

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

Qualifiers

Stage 1-3 breast cancer (BC).

Age 18-79 years.

HER-2 positive BC with planned HER2 targeted therapy (HER2TT) for curative intent.

Disqualifiers

Distant metastases detected clinically, radiographically, or histologically

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

Prior myocardial infarction (even if LVEF has normalized)

Prior heart failure (HF, including patients with preserved ejection fraction and normalized LVEF)

Trial design

Treatments tested in this trial

  • Intervention - Low Risk Group OR Intermediate Risk Group

Treatment groups

300 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Women's College Hospital

Lead sponsor

University Health Network, Toronto

Collaborator