Breast Cancer
Conditions
Keywords
CMF, HEC, EC, node positive, breast cancer
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
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).
Interventions
OTHERcardiac MRI
Patients will be submitted to extensive cardiac evaluation several years after completion of adjuvant chemotherapy
Sponsors
Centre Hospitalier Universitaire de Tivoli
Clinique Sainte Elisabeth
Centre Hospitalier Jolimont-Lobbes
Réseau Hospitalier Médecine Sociale d'Ath
Hôpital de Braine-l'Alleud
Jules Bordet Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Late cardiac toxicity | 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
| Measure | Time frame | Description |
|---|---|---|
| Late cardiac and cognitive toxicity | 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 |
Countries
Belgium
Outcome results
None listed