RecruitingNot ApplicableNCT05406635

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

A National Randomized Non-inferiority Trial: Imaging Versus Cardiac Biomarker Monitored HER2 Directed Therapy in Patients With Breast Cancer


Sponsor

Odense University Hospital

Enrollment

220 participants

Start Date

Oct 1, 2021

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study compares two ways of monitoring the heart health of breast cancer patients receiving HER2-targeted therapy (a treatment for a specific subtype of breast cancer). One method uses regular cardiac imaging (scans), and the other uses blood tests (biomarkers). The goal is to find the safest and most efficient monitoring approach. **You may be eligible if...** - You have HER2-positive breast cancer that has not spread to other organs - You are scheduled to receive standard chemotherapy plus trastuzumab (with or without pertuzumab) - You are 18 or older - Your heart is in normal sinus rhythm and your heart function (LVEF) is above 55% - Your heart biomarker blood tests are within normal range **You may NOT be eligible if...** - You have contraindications to cardiac MRI - You have significant lung disease (COPD with reduced lung function) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTBiomarkers: 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.


Locations(4)

Aalborg University Hospital

Aalborg, Denmark

Rigshospitalet

Copenhagen, Denmark

Herlev University Hospital

Herlev, Denmark

Odense University Hospital

Odense, Denmark

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NCT05406635


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