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Imaging Versus Cardiac Biomarker Monitored HER2 Directed Therapy in Patients With Breast Cancer

RECRUITINGN/ASponsored by Odense University Hospital
Actively Recruiting
PhaseN/A
SponsorOdense University Hospital
Started2021-10-01
Est. completion2026-02-01
Eligibility
Age18 Years – 90 Years
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05406635

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

Age: 18 Years – 90 YearsSex: FEMALEHealthy volunteers accepted
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

Conditions5

Breast CancerCancerCardiotoxicityHER2-positive Breast CancerHeart Disease

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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