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)
18 Years
90 Years
Female
Breast Cancer
Trial Information
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)
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).
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Late cardiac toxicity
Outcome 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. Analysis of the primary endpoint will involve a comparison of the CMF-treated patients versus the pooled anthracycline treated patients (EC and HEC).
Outcome Time Frame:
Exams will be performed only once, which will take place several years after the completion of chemotherapy (up to 15 years)
Safety Issue:
Yes
Principal Investigator
Evandro de Azambuja, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Jules Bordet Institute
Authority:
Belgium: Ethics Committee
Study ID:
CE1740
NCT ID:
NCT01554943
Start Date:
July 2010
Completion Date:
April 2013
Related Keywords:
- Breast Cancer
- CMF
- HEC
- EC
- node positive
- breast cancer
- Breast Neoplasms
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