MD, PhD, postdoc. Ann Banke Department of Cardiology, Odense University Hospital
Projektet i tal
OPEN undersøgelse/kliniske data
Forventet # af deltagere
Inkluderet antal deltagere
Forventede deltagere med prøver
Inkluderede deltagere med prøver
A national randomized non-inferiority trial:
Imaging versus cardiac biomarker monitored HER2 directed therapy in patients with breast cancer
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.
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 have in addition to traditional chemotherapy significantly improved survival in HER2 positive breast cancer, but induce a risk of left ventricular dysfunction and heart failure. Regular imaging based evaluation of myocardial function with measurement of left ventricular ejection fraction (LVEF) is therefore recommended during HER2 directed therapy. This is performed by either an echocardiography or a MUGA scan, which is associated with radiation exposure. Both types of scans are resources demanding for both patients and the healthcare system, and since biomarkers have been proposed as another modality in assessment of myocardial injury, the purpose of this study is to evaluate, if biomarkers can replace imaging based examinations of myocardial function during HER2 directed therapy.
Description of the cohort
Women with localized HER2-positive breast cancer scheduled for HER2 directed therapy will be recruited from the departments of Oncology at Odense University Hospital, Herlev University Hospital and Aarhus University Hospital.
Data and biological material
All patients will go through a MUGA scan or echocardiogram, biomarker collection and will answer the EuroQoL-5 Dimensions 5-Levels Health Status Questionnaire five times during their treatment. At baseline and three months after end of treatment a cardiac magnetic resonance imaging and ECG will be obtained.
Collaborating researchers and departments
Dep. of Oncology, OUH, Dep. of Nuclear Medicine, OUH, Dep. of Cardiology, Herlev University Hospital, Dep. of Oncology Herlev University Hospital, Dep. of Nuclear Medicine, Herlev University Hospital, Dep. of Cardiology, Aarhus University Hospital, Dep. of Oncology Aarhus University Hospital