JUdicious Surveillance for Trastuzumab Induced Cardiotoxicity in the First Year

Launched by WOMEN'S COLLEGE HOSPITAL · Apr 8, 2025

Keywords

ClinConnect Summary

This clinical trial, named "JUdicious Surveillance for Trastuzumab Induced Cardiotoxicity in the First Year," is looking at how to better monitor heart health in patients with early-stage breast cancer that is positive for the HER2 receptor. These patients need special treatments that can sometimes affect the heart. Currently, patients undergo heart tests every three months during treatment, even if they feel fine or have no heart problems. However, research shows that many of these tests don't change treatment plans and may be unnecessary, causing stress and delaying care.

In this study, researchers will include 300 participants aged 18 to 79 who have HER2 positive breast cancer and are starting targeted therapy. They will group patients based on their risk of heart issues—low or intermediate. Instead of the usual three-month testing for everyone, those at lower risk will be tested every six months, while those at intermediate risk will be tested every four months. The goal is to see if this personalized approach can safely reduce the number of tests while still keeping patients healthy. If successful, it could lead to less stress, lower healthcare costs, and a better experience for patients undergoing treatment.

Gender

ALL

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.