NCT05406635 Imaging Versus Cardiac Biomarker Monitored HER2 Directed Therapy in Patients With Breast Cancer
| NCT ID | NCT05406635 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Odense University Hospital |
| Condition | Cardiotoxicity |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2021-10-01 |
| Primary Completion | 2026-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 220 participants in total. It began in 2021-10-01 with a primary completion date of 2026-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Ann Banke, MD PHD
PRINCIPAL INVESTIGATOR
Odense Universitetshospital
Frequently Asked Questions
Who can join the NCT05406635 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 90 Years, studying Cardiotoxicity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05406635 currently recruiting?
Yes, NCT05406635 is actively recruiting participants. Contact the research team at Ann.Banke@rsyd.dk for enrollment information.
Where is the NCT05406635 trial being conducted?
This trial is being conducted at Aalborg, Denmark, Copenhagen, Denmark, Herlev, Denmark, Odense, Denmark.
Who is sponsoring the NCT05406635 clinical trial?
NCT05406635 is sponsored by Odense University Hospital. The principal investigator is Ann Banke, MD PHD at Odense Universitetshospital. The trial plans to enroll 220 participants.