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NCT Number: NCT01554943

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

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

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Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Jules Bordet Institute

Brussels, 1000, Belgium

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiac MRI

Other

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

Primary outcomes

  1. Late cardiac toxicity

    Time frame: 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 outcomes

  1. Late cardiac and cognitive toxicity

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Jules Bordet Institute

Other

Collaborators

  • Centre Hospitalier Jolimont-Lobbes
  • Centre Hospitalier Universitaire de Tivoli
  • Clinique Sainte Elisabeth
  • Hôpital de Braine-l'Alleud
  • Réseau Hospitalier Médecine Sociale d'Ath

Registry information

Official study 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)

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Mar 15, 2012
Registry last updated
Aug 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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