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

NCT ID: NCT01554943

Last Updated: 2013-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2013-08-31

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).

Conditions

Breast Cancer

Keywords

CMF; HEC; EC; node positive; breast cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

CMF

adjuvant standard CMF given from 1988 to 1996

Group Type: ACTIVE_COMPARATOR

cardiac MRI

Intervention Type: OTHER

Patients will be submitted to extensive cardiac evaluation several years after completion of adjuvant chemotherapy

EC

Adjuvant EC chemotherapy given from 1988 to 1996

Group Type: EXPERIMENTAL

cardiac MRI

Intervention Type: OTHER

Patients will be submitted to extensive cardiac evaluation several years after completion of adjuvant chemotherapy

HEC

High dose epirubicin (HEC) given from 1988 to 1996

Group Type: EXPERIMENTAL

cardiac MRI

Intervention Type: OTHER

Patients will be submitted to extensive cardiac evaluation several years after completion of adjuvant chemotherapy

Interventions

cardiac MRI

Patients will be submitted to extensive cardiac evaluation several years after completion of adjuvant chemotherapy

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Tivoli

OTHER

Sponsor Role: collaborator

Clinique Sainte Elisabeth

UNKNOWN

Sponsor Role: collaborator

Centre Hospitalier Jolimont-Lobbes

UNKNOWN

Sponsor Role: collaborator

Réseau Hospitalier Médecine Sociale d'Ath

UNKNOWN

Sponsor Role: collaborator

Hôpital de Braine-l'Alleud

OTHER

Sponsor Role: collaborator

Jules Bordet Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Evandro de Azambuja, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Jules Bordet Institute

Locations

Jules Bordet Institute

Brussels, , Belgium

Countries

Belgium

References

Piccart MJ, Di Leo A, Beauduin M, Vindevoghel A, Michel J, Focan C, Tagnon A, Ries F, Gobert P, Finet C, Closon-Dejardin MT, Dufrane JP, Kerger J, Liebens F, Beauvois S, Bartholomeus S, Dolci S, Lobelle JP, Paesmans M, Nogaret JM. Phase III trial comparing two dose levels of epirubicin combined with cyclophosphamide with cyclophosphamide, methotrexate, and fluorouracil in node-positive breast cancer. J Clin Oncol. 2001 Jun 15;19(12):3103-10. doi: 10.1200/JCO.2001.19.12.3103.

Reference Type: BACKGROUND

PMID: 11408507 (View on PubMed)

de Azambuja E, Paesmans M, Beauduin M, Vindevoghel A, Cornez N, Finet C, Ries F, Closon-Dejardin MT, Kerger J, Gobert P, Focan C, Tagnon A, Dolci S, Nogaret JM, di Leo A, Piccart-Gebhart MJ. Long-term benefit of high-dose epirubicin in adjuvant chemotherapy for node-positive breast cancer: 15-year efficacy results of the Belgian multicentre study. J Clin Oncol. 2009 Feb 10;27(5):720-5. doi: 10.1200/JCO.2008.17.2155. Epub 2008 Dec 22.

Reference Type: BACKGROUND

PMID: 19103732 (View on PubMed)

de Azambuja E, Ameye L, Diaz M, Vandenbossche S, Aftimos P, Bejarano Hernandez S, Shih-Li C, Delhaye F, Focan C, Cornez N, Vindevoghel A, Beauduin M, Lemort M, Paesmans M, Suter T, Piccart-Gebhart M. Cardiac assessment of early breast cancer patients 18 years after treatment with cyclophosphamide-, methotrexate-, fluorouracil- or epirubicin-based chemotherapy. Eur J Cancer. 2015 Nov;51(17):2517-24. doi: 10.1016/j.ejca.2015.08.011. Epub 2015 Aug 27.

Reference Type: DERIVED

PMID: 26321502 (View on PubMed)

Other Identifiers

CE1740

Identifier Type: -

Identifier Source: org_study_id