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

NCT05406635 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2025-04-08

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Biomarkers: Troponins and natriuretic peptides

Biomarker monitored treatment with measurement of NT-proBNP and cTNT / TNI in weeks 0, 9, 18, 30 and 48 of the treatment period.

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • Aalborg University Hospital

    collaborator OTHER

  • University of Copenhagen

    collaborator OTHER

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Ann Banke, MD PHD · Odense Universitetshospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2026-02-01
Completion
2027-09-01

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05406635 on ClinicalTrials.gov