Imaging Versus Cardiac Biomarker Monitored HER2 Directed Therapy in Patients With Breast Cancer
Recruiting · NCT05406635 · Interventional (participants receive a specific treatment) · Lead sponsor: Odense University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Biomarkers: Troponins and natriuretic peptides
What this trial is about
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.
Who can take part
Age range
18 Years to 90 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- Contra indications for cardiac magnetic resonance imaging (CMRI)
- Chronic obstructive pulmonary disease with FEV1 \<80 % of predicted
Where it is running
4 locations listed.
- Aalborg University Hospital - Aalborg, Denmark
- Rigshospitalet - Copenhagen, Denmark
- Herlev University Hospital - Herlev, Denmark
- Odense University Hospital - Odense, Denmark