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Breast CancerPhase 2NCT01554943

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

A Phase 2 study testing cardiac MRI in people with Breast Cancer, run by Jules Bordet Institute at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 90 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
cardiac MRI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
1 siteBelgium
Study dates
Jul 2010to Aug 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Jules Bordet Institute

    Brussels, 1000

Other trials in Belgium

About this study

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)

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

Read more

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
Read the 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
Being tested
cardiac MRI
Keywords
CMF, HEC, EC, node positive, breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cardiac MRIOther

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

Study groups in NCT01554943
Study groupRoleWhat they receive
CMFActive comparatoradjuvant standard CMF given from 1988 to 1996
Receives: Other: cardiac MRI
ECExperimentalAdjuvant EC chemotherapy given from 1988 to 1996
Receives: Other: cardiac MRI
HECExperimentalHigh dose epirubicin (HEC) given from 1988 to 1996
Receives: Other: cardiac MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (1)

  1. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2012 (estimated)
  2. Study startJul 2010
  3. Primary completionAug 2013
  4. Study completionAug 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01554943
Sponsor's protocol ID
CE1740
Status last verified
Aug 2013
First submitted
8 Mar 2012
Last updated
30 Aug 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 11408507

  • 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.

    PubMed 19103732

  • 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.

    PubMed 26321502

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cardiac MRI in people with Breast Cancer, run by Jules Bordet Institute at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01554943, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2013.

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