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

NCT01554943 | Completed Phase 2

• 1 other identifier: CE1740
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer

Keywords

CMF; HEC; EC; node positive; breast cancer

Outcome Measures

Primary Outcomes (1)

• Late cardiac toxicity

  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).

  Exams will be performed only once, which will take place several years after the completion of chemotherapy (up to 15 years)

Secondary Outcomes (1)

• 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)

Study Arms (3)

CMF

ACTIVE COMPARATOR

adjuvant standard CMF given from 1988 to 1996

Other: cardiac MRI

EC

EXPERIMENTAL

Adjuvant EC chemotherapy given from 1988 to 1996

Other: cardiac MRI

HEC

EXPERIMENTAL

High dose epirubicin (HEC) given from 1988 to 1996

Other: cardiac MRI

Interventions

cardiac MRI OTHER

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

CMF; EC; HEC

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Death
• Breast cancer recurrence
• Unwilling to perform exams as per protocol

Sponsors & Collaborators

• Jules Bordet Institute: lead
• Centre Hospitalier Universitaire de Tivoli: collaborator
• Clinique Sainte Elisabeth: collaborator
• Centre Hospitalier Jolimont-Lobbes: collaborator
• Réseau Hospitalier Médecine Sociale d'Ath: collaborator
• Hôpital de Braine-l'Alleud: collaborator

Study Sites (1)

Jules Bordet Institute

Brussels, 1000, Belgium

Location

Related Publications (3)

• 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.

  PMID: 11408507 BACKGROUND

• 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.

  PMID: 19103732 BACKGROUND

• 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.

  PMID: 26321502 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Evandro de Azambuja, MD, PhD

  Jules Bordet Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2012
• First Posted: March 15, 2012
• Study Start: July 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 30, 2013

Record last verified: 2013-08

Locations

BE (1)