Imaging Versus Cardiac Biomarker Monitored HER2 Directed Therapy in Patients With Breast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-90
SponsorOdense University Hospital
About this trial
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 criteria
Qualifiers
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
Disqualifiers
Contra indications for cardiac magnetic resonance imaging (CMRI)
Chronic obstructive pulmonary disease with FEV1 <80 % of predicted
Trial design
Treatments tested in this trial
- Biomarkers: Troponins and natriuretic peptides
Treatment groups
220 Participants
are divided into 2 treatment groupsSponsors and collaborators
Odense University Hospital
Lead sponsor
Aarhus University Hospital
Collaborator
Aalborg University Hospital
Collaborator
University of Copenhagen
Collaborator
Source ClinicalTrials.gov