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

Breast Cancer Clinical Trial

Official title: 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

Clinical Trial 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

Clinical Trial 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). ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT01554943
• Study type: Interventional
• Source: Jules Bordet Institute
• Status: Completed
• Phase: Phase 2
• Start date: July 2010
• Completion date: August 2013