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Late Cardiac Evaluation of the Three Arm Belgian Trial Involving Node-positive Early Breast Cancer Patients

Jules Bordet Institute · 2010
ClinicalTrials.gov · Datasets · License: Public Domain · 2010
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breast-cancer
Late Cardiac Evaluation of the Three Arm Belgian Trial A phase III randomized trial involving node-positive early breast cancer patients with a long median follow-up (\~ 15 years) OBJECTIFS Primary: • To compare the incidence of late cardiac events between anthracycline and non-anthracycline chemotherapy given to node-positive breast cancer patients in the Belgian three arm randomized clinical trial Secondary: * To compare the late incidence of cardiac events between higher and lower dose anthracycline treated node-positive breast cancer patients; * To compare anthracyclines (higher and lower doses) and non-anthracycline chemotherapy for: * left ventricular diastolic function assessed by Echo * exercise capacity assessed by 6-minute walk test (6MWT) * cardiac morphology (myocardial inflammation or injury, fibrosis, LVEF) assessed by MRI * serum cardiac biomarkers (BNP and TNT) * patient-reported cardiac symptoms * patient-reported cardiac symptoms assessed by QOL questionnaires are associated with subclinical findings on LVEF assessment * cognitive function, functional autonomy, and psychological distress
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