Comparing imaging and blood tests for monitoring heart health during HER2 therapy in breast cancer patients
A National Randomized Non-inferiority Trial: Imaging Versus Cardiac Biomarker Monitored HER2 Directed Therapy in Patients With Breast Cancer
This study is testing if blood tests can safely replace imaging to check heart health in breast cancer patients receiving HER2 therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | Female |
| Sponsor | Odense University Hospital Academic / other |
| Drugs / interventions | trastuzumab, pertuzumab, chemotherapy, radiation |
| Locations | 4 sites (Aalborg and 3 other locations) |
| Trial ID | NCT05406635 on ClinicalTrials.gov |
What this trial studies
This study evaluates whether cardiac biomarkers can effectively replace imaging methods for monitoring heart function in patients undergoing HER2-directed therapy for breast cancer. Approximately 15% of breast cancer cases are HER2-positive, which can lead to heart complications during treatment. The study will randomly assign participants to receive either standard imaging evaluations or biomarker assessments to monitor heart health throughout their treatment. It aims to reduce the resource demands of imaging while ensuring patient safety and effective monitoring.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with localized HER2-positive breast cancer scheduled for HER2-directed therapy.
Not a fit: Patients with contraindications for cardiac imaging or chronic obstructive pulmonary disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could simplify heart monitoring for breast cancer patients, reducing the need for imaging and associated healthcare costs.
How similar studies have performed: While the use of biomarkers for monitoring cardiac health is promising, this specific approach of replacing imaging with biomarkers in HER2 therapy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aalborg and 3 other locations
- Aalborg University Hospital — Aalborg, Denmark (Recruiting)
- Rigshospitalet — Copenhagen, Denmark (Recruiting)
- Herlev University Hospital — Herlev, Denmark (Not_yet_recruiting)
- Odense University Hospital — Odense, Denmark (Recruiting)
Study contacts
- Principal investigator: Ann Banke, MD PHD — Odense Universitetshospital
- Study coordinator: Ann Banke, MD, PHD
- Email: Ann.Banke@rsyd.dk
- Phone: +4526278303
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.