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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Centre Hospitalier Universitaire Tivoli
Clinique Sainte Elisabeth
Centre Hospitalier Jolimont-Lobbes
Réseau Hospitalier Médecine Sociale d'Ath
Hôpital de Braine-l'Alleud
Information provided by (Responsible Party):
Jules Bordet Institute
ClinicalTrials.gov Identifier:
NCT01554943
First received: March 8, 2012
Last updated: March 15, 2013
Last verified: March 2013
History of Changes
  Purpose

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

Condition Intervention Phase
Breast Cancer
 Other: cardiac MRI
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Jules Bordet Institute:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
    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).


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
    • 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


Estimated Enrollment: 150
Study Start Date: July 2010
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01554943

Locations
Belgium
Jules Bordet Institute
Brussels, Belgium, 1000
Sponsors and Collaborators
Jules Bordet Institute
Centre Hospitalier Universitaire Tivoli
Clinique Sainte Elisabeth
Centre Hospitalier Jolimont-Lobbes
Réseau Hospitalier Médecine Sociale d'Ath
Hôpital de Braine-l'Alleud
Investigators
Principal Investigator: Evandro de Azambuja, MD, PhD Jules Bordet Institute
  More Information

Publications:

Responsible Party: Jules Bordet Institute
ClinicalTrials.gov Identifier: NCT01554943     History of Changes
Other Study ID Numbers: CE1740
Study First Received: March 8, 2012
Last Updated: March 15, 2013
Health Authority: Belgium: Ethics Committee

Keywords provided by Jules Bordet Institute:
CMF
HEC
EC
node positive
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013