A National Randomized Non-inferiority Trial: Imaging Versus Cardiac Biomarker Monitored HER2 Directed Therapy in Patients With Breast Cancer
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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 care system. The purpose of this study is to evaluate, if biomarkers can replace imaging based examinations of myocardial function during HER2 directed therapy.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Denmark
Aalborg University Hospital
RECRUITING
Aalborg
Rigshospitalet
RECRUITING
Copenhagen
Herlev University Hospital
NOT_YET_RECRUITING
Herlev
Odense University Hospital
RECRUITING
Odense
Contact Information
Primary
Ann Banke, MD, PHD
Ann.Banke@rsyd.dk
+4526278303
Time Frame
Start Date: 2021-10-01
Estimated Completion Date: 2027-09-01
Participants
Target number of participants: 220
Treatments
No_intervention: Standard imaging monitored treatment
Standard care + biomarkers, which are blinded until end of study.
Experimental: Intervention biomarker monitored treatment
biomarker monitored treatment + imaging, which is blinded until end of study
Related Therapeutic Areas
Sponsors
Leads: Odense University Hospital
Collaborators: University of Copenhagen, Aalborg University Hospital, Aarhus University Hospital