Imaging Versus Cardiac Biomarker Monitored HER2 Directed Therapy in Patients With Breast Cancer
A National Randomized Non-inferiority Trial: Imaging Versus Cardiac Biomarker Monitored HER2 Directed Therapy in Patients With Breast Cancer
Odense University Hospital
220 participants
Oct 1, 2021
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- 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 Criteria2
- Contra indications for cardiac magnetic resonance imaging (CMRI)
- Chronic obstructive pulmonary disease with FEV1 \<80 % of predicted
Interventions
Biomarker monitored treatment with measurement of NT-proBNP and cTNT / TNI in weeks 0, 9, 18, 30 and 48 of the treatment period.
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT05406635