Prospective Observational Study in Patients With Metastatic Breast Cancer Treated With Anthracyclines

April 22, 2016 updated by: Teva Pharma

Screening and Management of Cardiovascular Risk in Belgian Women Aged > or = 65 Years With Metastatic Breast Cancer Before and After Anthracycline Treatment

This is an open, multicentre, prospective observational (non-interventional) study, performed in Belgium.

Principal objectives:

  1. To evaluate the prevalence of cardiovascular risk factors and cardiac function (as routinely evaluated) before treatment with anthracyclines of patients with metastatic breast cancer (MBC) aged > or = 65 years
  2. To observe the management of cardiovascular risk during and after anthracycline treatment
  3. To compare liposomal versus non-liposomal anthracycline therapy (ratio 1:1) on cardiac function, outcome and quality of life (EORTC QLQ-C30)

Secondary objectives:

  1. To evaluate the efficacy of anthracyclines on progression free survival and tumor response as routinely measured (e.g. recist criteria, tumor markers and other exams)
  2. To evaluate cardiovascular event type: ECG changes, arrhythmia, decrease of ejection fraction, heart failure and rate according to allocated treatment.
  3. To find out how quality of life, e.g. such as described according to EORTC QLQ-C30 criteria or Karnofsky index is achieved in the various patient subgroups
  4. To correlate the therapeutic choice and posology of anthracyclines for MBC with Cardiovascular risk at baseline
  5. To calculate the cardiovascular risk according to SCORE

Study Overview

Status

Completed

Conditions

Detailed Description

The physician will be requested:

  • To include 15 consecutive patients aged > or = 65 years who will be treated with anthracyclines in first and second line MBC. The physician will be encouraged to enrol 2 arms of 8 patients (one treated with liposomal and one with non-liposomal anthracyclines) for observation and comparison. Each arm will be closed as soon as 150 patients are included at a national level.
  • To report their cardiovascular risk factors
  • To provide the results of routinely performed cardiac evaluation before treatment
  • To monitor routinely cardiovascular parameters during treatment and report them afterwards
  • To monitor efficacy and tolerance of treatments, as normal practice prescribes, reported and related to the variables described in objectives
  • To ensure that quality of life will be assessed with the EORTC QLQ-C30 questionnaire
  • To monitor and report progression free survival and cardiac events
  • To record and transmit spontaneously reported adverse events. These will be handled according to legal requirements

Follow-up will cover a period of 15 months following inclusion.

The study will have 3 visits and 2 contacts:

  • One visit at entry
  • One visit after 3 cycles of anthracycline containing therapy
  • One visit at the end of treatment
  • Contact at 9 months after inclusion
  • Contact at 15 months after inclusion

It is planned to include data from 15 consecutive female patients per specialized center in Belgium.

The total number of patients aimed is 300.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium, 2020
        • ZNA Middelheim
      • Arlon, Belgium, 6700
        • Cliniques du Sud Lux - St Joseph
      • Bonheiden, Belgium, 2820
        • Imelda
      • Bouge, Belgium, 5004
        • Clinique Saint-Luc
      • Brasschaat, Belgium, 2930
        • AZ Klina
      • Brugge, Belgium, 8000
        • AZ St Jan
      • Brussel, Belgium, 1090
        • UZ Brussel
      • Brussels, Belgium, 1020
        • CHU Brugmann
      • Brussels, Belgium, 1070
        • Erasme
      • Brussels, Belgium, 1180
        • CHIREC - Centre Hospitalier Interrégional Edith Cavell
      • Chimay, Belgium, 6460
        • CSF
      • Duffel, Belgium, 2570
        • AZ St-Maarten
      • Edegem, Belgium, 2650
        • UZA
      • Geel, Belgium, 2440
        • AZ St-Dimpna
      • Ghent, Belgium, 9000
        • AZ St-Lucas
      • Merksem, Belgium, 2170
        • ZNA Jan Palfijn
      • Namur, Belgium, 5000
        • CMSE
      • Namur, Belgium, 5000
        • CHR
      • Oostende, Belgium, 8400
        • AZ Damiaan
      • Ottignies, Belgium, 1340
        • Clinique St Pierre
      • St-Niklaas, Belgium, 9100
        • AZ Nikolaas
      • Tournai, Belgium, 7500
        • Centre Hospitalier de Wallonie picarde - site IMC
      • Verviers, Belgium, 4800
        • CHPLT
      • Yvoir, Belgium, 5530
        • CHU Mont-Godinne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Belgian women aged > or = 65 years with metastatic breast cancer before and after anthracycline treatment.

Patients will be included in 24 centers specialized in the treatment of breast cancer, in Belgium.

Description

Inclusion Criteria:

  • women aged 65 years old or more
  • with confirmed metastatic breast cancer (MBC)
  • who will be treated with anthracyclines in first or second line
  • who have a Karnofsky score at baseline of 50
  • who agree and are able to fill in the EORTC QLQ-C30 questionnaire
  • who gave their informed consent

Exclusion Criteria:

  • women having contra-Indications for anthracyclines
  • women aged < 65 years old
  • with no metastatic breast cancer
  • who will not be eligible for an anthracycline treatment in first or second line MBC
  • who have a Karnofsky less than 50
  • who disagree or are unable to fill in the EORTC QLQ-C30 questionnaire
  • women refusing or not having signed their informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cardiovascular risk factors
Time Frame: 15 months
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teva Pharma

Investigators

  • Principal Investigator: Christel Fontaine, MD, Universitair Ziekenhuis Brussel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

March 14, 2012

First Submitted That Met QC Criteria

March 15, 2012

First Posted (Estimate)

March 16, 2012

Study Record Updates

Last Update Posted (Estimate)

April 25, 2016

Last Update Submitted That Met QC Criteria

April 22, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MyCard

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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