Status:
NOT_YET_RECRUITING
JUdicious Surveillance for Trastuzumab Induced Cardiotoxicity in the First Year
Lead Sponsor:
Women's College Hospital
Collaborating Sponsors:
University Health Network, Toronto
Conditions:
Cardiovascular Health
Breast Cancer
Eligibility:
All Genders
18-79 years
Phase:
NA
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 the...
Eligibility Criteria
Inclusion
- Stage 1-3 breast cancer (BC).
- Age 18-79 years.
- HER-2 positive BC with planned HER2 targeted therapy (HER2TT) for curative intent.
Exclusion
- 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%
- 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.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2033
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06930521
Start Date
May 1 2025
End Date
June 1 2033
Last Update
April 16 2025
Active Locations (1)
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1
Women's College Hospital
Toronto, Ontario, Canada, M5S 1B2