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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01554943
Recruitment Status : Completed
First Posted : March 15, 2012
Last Update Posted : August 30, 2013
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief 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

Condition or disease Intervention/treatment Phase
Breast Cancer Other: cardiac MRI Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : July 2010
Primary Completion Date : August 2013
Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jules Bordet Institute
ClinicalTrials.gov Identifier: NCT01554943     History of Changes
Other Study ID Numbers: CE1740
First Posted: March 15, 2012    Key Record Dates
Last Update Posted: August 30, 2013
Last Verified: August 2013

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