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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01555944
Recruitment Status : Completed
First Posted : March 16, 2012
Last Update Posted : April 25, 2016
Information provided by (Responsible Party):
Teva Pharma

Brief Summary:

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

Condition or disease
Metastatic Breast Cancer

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.

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Screening and Management of Cardiovascular Risk in Belgian Women Aged > or = 65 Years With Metastatic Breast Cancer Before and After Anthracycline Treatment
Study Start Date : February 2012
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Primary Outcome Measures :
  1. cardiovascular risk factors [ Time Frame: 15 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01555944

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ZNA Middelheim
Antwerp, Belgium, 2020
Cliniques du Sud Lux - St Joseph
Arlon, Belgium, 6700
Bonheiden, Belgium, 2820
Clinique Saint-Luc
Bouge, Belgium, 5004
Brasschaat, Belgium, 2930
AZ St Jan
Brugge, Belgium, 8000
CHU Brugmann
Brussels, Belgium, 1020
Brussels, Belgium, 1070
CHIREC - Centre Hospitalier Interrégional Edith Cavell
Brussels, Belgium, 1180
UZ Brussel
Brussel, Belgium, 1090
Chimay, Belgium, 6460
AZ St-Maarten
Duffel, Belgium, 2570
Edegem, Belgium, 2650
AZ St-Dimpna
Geel, Belgium, 2440
AZ St-Lucas
Ghent, Belgium, 9000
ZNA Jan Palfijn
Merksem, Belgium, 2170
Namur, Belgium, 5000
Namur, Belgium, 5000
AZ Damiaan
Oostende, Belgium, 8400
Clinique St Pierre
Ottignies, Belgium, 1340
AZ Nikolaas
St-Niklaas, Belgium, 9100
Centre Hospitalier de Wallonie picarde - site IMC
Tournai, Belgium, 7500
Verviers, Belgium, 4800
CHU Mont-Godinne
Yvoir, Belgium, 5530
Sponsors and Collaborators
Teva Pharma
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Principal Investigator: Christel Fontaine, MD Universitair Ziekenhuis Brussel

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Responsible Party: Teva Pharma Identifier: NCT01555944     History of Changes
Other Study ID Numbers: MyCard
First Posted: March 16, 2012    Key Record Dates
Last Update Posted: April 25, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases