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

This study has been completed.
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: August 29, 2013
Last verified: August 2013
  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:


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


Enrollment: 73
Study Start Date: July 2010
Study Completion Date: August 2013
Primary Completion Date: August 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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