Actively Recruiting
Imaging Versus Cardiac Biomarker Monitored HER2 Directed Therapy in Patients With Breast Cancer
Led by Odense University Hospital · Updated on 2025-04-08
220
Participants Needed
4
Research Sites
308 weeks
Total Duration
On this page
Sponsors
O
Odense University Hospital
Lead Sponsor
A
Aarhus University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Due to a risk of heart failure during HER2 directed therapy in breast cancer, treatment is monitored with imaging of myocardial function, which is resource demanding for both patients and the health care system. The purpose of this study is to evaluate, if biomarkers can replace imaging based examinations of myocardial function during HER2 directed therapy.
CONDITIONS
Official Title
Imaging Versus Cardiac Biomarker Monitored HER2 Directed Therapy in Patients With Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with non-metastatic HER2 positive breast cancer
- Scheduled for standard chemotherapy and HER2 directed therapy with trastuzumab +/- pertuzumab
- Age over 18 years
- Sinus rhythm on ECG
- NT-proBNP below 125 pg/ml
- Troponin below threshold limit value
- Left ventricular ejection fraction over 55% by MUGA scan or echocardiogram
You will not qualify if you...
- Contraindications for cardiac magnetic resonance imaging (CMRI)
- Chronic obstructive pulmonary disease with FEV1 less than 80% of predicted
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Aalborg University Hospital
Aalborg, Denmark, 9000
Actively Recruiting
2
Rigshospitalet
Copenhagen, Denmark
Actively Recruiting
3
Herlev University Hospital
Herlev, Denmark
Not Yet Recruiting
4
Odense University Hospital
Odense, Denmark, 5000
Actively Recruiting
Research Team
A
Ann Banke, MD, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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