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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Biomarkers: Troponins and natriuretic peptides
Diagnostic testBiomarker monitored treatment with measurement of NT-proBNP and cTNT / TNI in weeks 0, 9, 18, 30 and 48 of the treatment period.
Treatment groups
220 Participants
are divided into 2 treatment groupsGroup A: Standard imaging monitored treatmentNo intervention 0 interventions
Group B: Intervention biomarker monitored treatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Left ventricular ejection fraction (LVEF)
LVEF on cardiac MR.
Time frame
Three months after treatment has ended.Secondary outcomes
1
The number of treatment interruptions due to suspected cardiotoxicity
Number of times treatment was paused due to suspected cardiotoxicity either based on imaging or biomarkes as defined in the protocol.
Time frame
Through study completion, an average of 1 year.2
The number of MUGA scans/echocardiograms
The number of MUGA scans/echocardiograms preformed during the study periode.
Time frame
Through study completion, an average of 1 year.3
The cumulative doses of trastuzumab and pertuzumab
The cumulative doses of trastuzumab and pertuzumab in mg.
Time frame
After end of treatment, an average of 1 year after inclusion.4
The proportion of patients treated for cardiotoxicity.
Number of patients referred to tratment for heart failure in the department of cardiology.
Time frame
Through study completion, an average of 1 yearOther outcomes
1
Safty outcome of left ventricular ejection fraction
Drop in LVEF below 45 %
Time frame
End of treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Odense University Hospital
Lead sponsor
Aarhus University Hospital
Collaborator
Aalborg University Hospital
Collaborator
University of Copenhagen
Collaborator
Source ClinicalTrials.gov