NCT01554943

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Jules Bordet Institute · Academic / Other
• Sex: Female
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The primary objective of this study is to compare the incidence of cardiac events \[(defined as asymptomatic systolic dysfunction (LVEF \< 50%, asymptomatic NYHA I) or symptomatic heart failure NYHA class II-IV either by Echo and/or by clinical exam (LVEF \< 50% and heart failure symptoms)\] between anthracycline and non-anthracycline chemotherapy treated node-positive breast cancer patients in a long-term follow-up. We will define a binary status for each patient: no cardiac event / one or more cardiac events. Analysis of the primary endpoint will involve a comparison of the CMF-treated patients versus the pooled anthracycline treated patients (EC and HEC). If a significant difference is detected, all paired comparisons will also be performed for the primary endpoint (CMF versus EC, CMF versus HEC, EC versus HEC).

Conditions

• Breast Cancer

Interventions

Type	Name	Description
OTHER	cardiac MRI	Patients will be submitted to extensive cardiac evaluation several years after completion of adjuvant chemotherapy

Timeline

• Start date: 2010-07-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2012-03-15
• Last updated: 2013-08-30

Locations

1 site across 1 country: Belgium