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

August 29, 2013 updated by: Jules Bordet Institute

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1000
        • Jules Bordet Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: CMF
adjuvant standard CMF given from 1988 to 1996
Other: cardiac MRI
Patients will be submitted to extensive cardiac evaluation several years after completion of adjuvant chemotherapy
EXPERIMENTAL: EC
Adjuvant EC chemotherapy given from 1988 to 1996
Other: cardiac MRI
Patients will be submitted to extensive cardiac evaluation several years after completion of adjuvant chemotherapy
EXPERIMENTAL: HEC
High dose epirubicin (HEC) given from 1988 to 1996
Other: cardiac MRI
Patients will be submitted to extensive cardiac evaluation several years after completion of adjuvant chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Late cardiac toxicity
Time Frame: Exams will be performed only once, which will take place several years after the completion of chemotherapy (up to 15 years)
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. Analysis of the primary endpoint will involve a comparison of the CMF-treated patients versus the pooled anthracycline treated patients (EC and HEC).
Exams will be performed only once, which will take place several years after the completion of chemotherapy (up to 15 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Late cardiac and cognitive toxicity
Time Frame: Exams will be performed only once, which will take place several years after the completion of chemotherapy (up to 15 years)
  • 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: LVEF assessed by Echo; exercise capacity assessed by 6-minute walk test; cardiac morphology assessed by MRI; serum cardiac biomarkers; patient-reported cardiac symptoms assessed by QOL questionnaires; cognitive function, functional autonomy, and psychological distress
Exams will be performed only once, which will take place several years after the completion of chemotherapy (up to 15 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jules Bordet Institute

Collaborators

Centre Hospitalier Universitaire de Tivoli
Hôpital de Braine-l'Alleud
Clinique Sainte Elisabeth
Centre Hospitalier Jolimont-Lobbes
Réseau Hospitalier Médecine Sociale d'Ath

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (ACTUAL)

August 1, 2013

Study Completion (ACTUAL)

August 1, 2013

Study Registration Dates

First Submitted

March 8, 2012

First Submitted That Met QC Criteria

March 14, 2012

First Posted (ESTIMATE)

March 15, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

August 30, 2013

Last Update Submitted That Met QC Criteria

August 29, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE1740

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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