Status:
RECRUITING
Imaging Versus Cardiac Biomarker Monitored HER2 Directed Therapy in Patients With Breast Cancer
Lead Sponsor:
Odense University Hospital
Collaborating Sponsors:
Aarhus University Hospital
Aalborg University Hospital
Conditions:
Cardiotoxicity
HER2-positive Breast Cancer
Eligibility:
FEMALE
18-90 years
Phase:
NA
Brief Summary
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 c...
Detailed Description
About 15% of breast cancer tumors express the Human Epidermal Growth Factor Receptor 2 (HER2), which is associated with a poor prognosis. Antibodies (trastuzumab and pertuzumab) directed against HER2 ...
Eligibility Criteria
Inclusion
- Patients with non-metastatic HER2 positive breast cancer
- Scheduled for standard chemotherapy and HER2 directed therapy with trastuzumab +/- pertuzumab
- Age \> 18 years
- Sinus rhythm on ECG
- NT-proBNP below125 pg/ml
- Troponin below threshold limit value
- LVEF \> 55% by MUGA scan or an echocardiogram
Exclusion
- Contra indications for cardiac magnetic resonance imaging (CMRI)
- Chronic obstructive pulmonary disease with FEV1 \<80 % of predicted
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT05406635
Start Date
October 1 2021
End Date
September 1 2027
Last Update
April 8 2025
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Aalborg University Hospital
Aalborg, Denmark, 9000
2
Rigshospitalet
Copenhagen, Denmark
3
Herlev University Hospital
Herlev, Denmark
4
Odense University Hospital
Odense, Denmark, 5000