Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
FEMALE
NCT05406635

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

Led by Odense University Hospital · Updated on 2025-04-08

220

Participants Needed

4

Research Sites

308 weeks

Total Duration

On this page

Sponsors

O

Odense University Hospital

Lead Sponsor

A

Aarhus University Hospital

Collaborating Sponsor

AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 90Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with non-metastatic HER2 positive breast cancer
  • Scheduled for standard chemotherapy and HER2 directed therapy with trastuzumab +/- pertuzumab
  • Age over 18 years
  • Sinus rhythm on ECG
  • NT-proBNP below 125 pg/ml
  • Troponin below threshold limit value
  • Left ventricular ejection fraction over 55% by MUGA scan or echocardiogram
Not Eligible

You will not qualify if you...

  • Contraindications for cardiac magnetic resonance imaging (CMRI)
  • Chronic obstructive pulmonary disease with FEV1 less than 80% of predicted

AI-Screening

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Trial Site Locations

Total: 4 locations

1

Aalborg University Hospital

Aalborg, Denmark, 9000

Actively Recruiting

2

Rigshospitalet

Copenhagen, Denmark

Actively Recruiting

3

Herlev University Hospital

Herlev, Denmark

Not Yet Recruiting

4

Odense University Hospital

Odense, Denmark, 5000

Actively Recruiting

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Research Team

A

Ann Banke, MD, PHD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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