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Compares treatment options for Cardiotoxicity
Official title Imaging Versus Cardiac Biomarker Monitored HER2 Directed Therapy in Patients With Breast Cancer
ClinicalTrials.gov ID: NCT05406635
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90, women only
You may be able to join if
- 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
You likely can't join if
- Contra indications for cardiac magnetic resonance imaging (CMRI)
- Chronic obstructive pulmonary disease with FEV1 \<80 % of predicted
See the full eligibility 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
- Contra indications for cardiac magnetic resonance imaging (CMRI)
- Chronic obstructive pulmonary disease with FEV1 \<80 % of predicted
The study team makes the final eligibility decision.
Where it's taking place
- Aalborg, Denmark
- Copenhagen, Denmark
- Herlev, Denmark
- Odense, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aalborg, Denmark; Copenhagen, Denmark; Herlev, Denmark; Odense, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.