Judicious heart monitoring during HER2-targeted therapy for breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study focuses on patients with HER2-positive early-stage breast cancer who will receive HER2-targeted therapy. Participants are categorized into low or intermediate cardiovascular risk groups to determine if a tailored cardiac surveillance approach is as safe as standard quarterly tests. The goal is to see whether a personalized monitoring strategy can reduce unnecessary testing, stress, and costs without compromising heart safety during treatment. The trial aims to enroll about 300 patients across participating institutions in Toronto. Enrollment criteria exclude those with significant pre-existing heart disease, reduced baseline heart function, or prior high cumulative exposure to certain chemotherapies.

Why it matters

Who can join: the full rules

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.

Where it's running

• Toronto General Hospital
  Toronto, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Husam Abdel-Qadir, MD, PhD, FRCPC
• Email: husam.abdel-qadir@wchospital.ca
• Phone: 416-323-7723

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.