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

NCT01554943 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2013-08-30

No results posted yet for this study

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

Interventions

OTHER

cardiac MRI

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

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Tivoli

    collaborator OTHER

  • Clinique Sainte Elisabeth

    collaborator UNKNOWN

  • Centre Hospitalier Jolimont-Lobbes

    collaborator UNKNOWN

  • Réseau Hospitalier Médecine Sociale d'Ath

    collaborator UNKNOWN

  • Hôpital de Braine-l'Alleud

    collaborator OTHER

  • Jules Bordet Institute

    lead OTHER

Principal Investigators

  • Evandro de Azambuja, MD, PhD · Jules Bordet Institute

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01554943 on ClinicalTrials.gov