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

Breast Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01554943
• Other study ID #: CE1740
• Status: Completed
• Phase: Phase 2
• First received: March 8, 2012
• Last updated: August 29, 2013
• Start date: July 2010
• Est. completion date: August 2013

Study information

• Verified date: August 2013
• Source: Jules Bordet Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• cardiac MRI
Patients will be submitted to extensive cardiac evaluation several years after completion of adjuvant chemotherapy

Locations

Country	Name	City	State
Belgium	Jules Bordet Institute	Brussels

Sponsors (6)

Lead Sponsor	Collaborator
Jules Bordet Institute	Centre Hospitalier Jolimont-Lobbes, Centre Hospitalier Universitaire Tivoli, Clinique Sainte Elisabeth, Hôpital de Braine-l'Alleud, Réseau Hospitalier Médecine Sociale d'Ath

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	Late cardiac and cognitive toxicity	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	Exams will be performed only once, which will take place several years after the completion of chemotherapy (up to 15 years)	Yes