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

Free University of Brussels (ULB)

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Other: cardiac MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT01554943

CE1740

Details and patient eligibility

About

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

Full 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).

Enrollment: 73 patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Alive, free of any recurrence, Not lost to follow-up
• Last workup should be no older than 1 year to exclude relapses. If this is older than 1 year, a new workup (PE, blood tests and MMG) will be performed prior to the entry in this study
• Patients previously diagnosed with CHF who are free of recurrence will also be invited to participate, if there is no contra-indication
• Patients should be able to perform the prescribed assessments

Exclusion criteria

• Death
• Breast cancer recurrence
• Unwilling to perform exams as per protocol

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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73 participants in 3 patient groups

CMF

Active Comparator group

Description:

adjuvant standard CMF given from 1988 to 1996

Treatment:

Other: cardiac MRI

EC

Experimental group

Description:

Adjuvant EC chemotherapy given from 1988 to 1996

Treatment:

Other: cardiac MRI

HEC

Experimental group

Description:

High dose epirubicin (HEC) given from 1988 to 1996

Treatment:

Other: cardiac MRI