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Search / Trial NCT05406635

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

Launched by ODENSE UNIVERSITY HOSPITAL · Jun 3, 2022

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new way to monitor heart health in women with HER2-positive breast cancer who are receiving treatment. Typically, doctors use imaging tests to check how well the heart is functioning during treatment, but these tests can be time-consuming and expensive. The goal of this study is to find out if measuring certain blood markers (called biomarkers) can be a simpler and more efficient way to keep track of heart health instead of relying solely on imaging.

To participate in this trial, women must be over 18 years old, have non-metastatic HER2-positive breast cancer, and be scheduled to receive standard chemotherapy along with HER2-directed therapy, such as trastuzumab or pertuzumab. Participants should have a normal heart function as shown by specific tests and should not have certain heart or lung conditions. If eligible, participants can expect to have their heart health monitored using blood tests during their treatment, which might make the process easier for them compared to traditional imaging methods. This study is currently recruiting participants, and it's an important step toward improving care for patients undergoing this type of treatment.

Gender

FEMALE

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

About Odense University Hospital

Odense University Hospital is a leading academic medical center located in Denmark, dedicated to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, the hospital is committed to enhancing patient outcomes and fostering collaboration among multidisciplinary teams. With a focus on translating scientific discoveries into practical applications, Odense University Hospital leverages its state-of-the-art facilities and expertise to conduct rigorous trials across various medical fields, ensuring adherence to the highest ethical and regulatory standards. Through these efforts, the hospital aims to contribute significantly to the global body of medical knowledge and improve the quality of care for patients both locally and internationally.

Locations

Copenhagen, , Denmark

Odense, , Denmark

Copenhagen, , Denmark

Aarhus, , Denmark

Aalborg, , Denmark

Herlev, , Denmark

Patients applied

0 patients applied

Trial Officials

Ann Banke, MD PHD

Principal Investigator

Odense Universitetshospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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