Phase
Condition
Cancer
Breast Cancer
Treatment
Intervention - Low Risk Group OR Intermediate Risk Group
Clinical Study ID
Ages 18-79 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Stage 1-3 breast cancer (BC).
Age 18-79 years.
HER-2 positive BC with planned HER2 targeted therapy (HER2TT) for curative intent.
Exclusion
Exclusion Criteria:
Distant metastases detected clinically, radiographically, or histologically
Baseline echocardiogram images of insufficient quality for a quantitative assessmentof 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 fractionand 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 CooperativeOncology 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 todetect emergent HF.
Study Design
Connect with a study center
Women's College Hospital
Toronto, Ontario M5S 1B2
CanadaSite Not Available
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