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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Teva Pharma
Sponsor:
Information provided by (Responsible Party):
Teva Pharma
ClinicalTrials.gov Identifier:
NCT01555944
First received: March 14, 2012
Last updated: October 16, 2012
Last verified: October 2012
  Purpose

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
Metastatic Breast Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Teva Pharma:

Estimated Enrollment: 320
Study Start Date: February 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Detailed Description:

The physician will be requested:

  • To include 16 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 160 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 16 consecutive female patients per specialized center in Belgium.

The total number of patients aimed is 320.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders 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.

Criteria

Inclusion Criteria:

  • women aged 65 years old or more
  • with confirmed and evaluable 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 measurable and evaluable 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01555944

Contacts
Contact: Ines EM Marinovic +32 3 820 73 71 Ines.Marinovic@tevabelgium.be
Contact: Ellen Rolin +32 3 820 73 71 Ellen.Rolin@tevabelgium.be

Locations
Belgium
ZNA Middelheim Recruiting
Antwerp, Belgium, 2020
Cliniques du Sud Lux - St Joseph Active, not recruiting
Arlon, Belgium, 6700
Imelda Recruiting
Bonheiden, Belgium, 2820
Clinique Saint-Luc Active, not recruiting
Bouge, Belgium, 5004
AZ KLINA Active, not recruiting
Brasschaat, Belgium, 2930
AZ St Jan Recruiting
Brugge, Belgium, 8000
UZ Brussel Active, not recruiting
Brussel, Belgium, 1090
Erasme Active, not recruiting
Brussels, Belgium, 1070
CHIREC - Centre Hospitalier Interrégional Edith Cavell Recruiting
Brussels, Belgium, 1180
CHU Brugmann Active, not recruiting
Brussels, Belgium, 1020
CSF Recruiting
Chimay, Belgium, 6460
AZ St-Maarten Recruiting
Duffel, Belgium, 2570
UZA Recruiting
Edegem, Belgium, 2650
AZ St-Dimpna Recruiting
Geel, Belgium, 2440
AZ St-Lucas Recruiting
Ghent, Belgium, 9000
ZNA Jan Palfijn Active, not recruiting
Merksem, Belgium, 2170
CMSE Active, not recruiting
Namur, Belgium, 5000
CHR Active, not recruiting
Namur, Belgium, 5000
AZ Damiaan Recruiting
Oostende, Belgium, 8400
Clinique St Pierre Active, not recruiting
Ottignies, Belgium, 1340
AZ Nikolaas Recruiting
St-Niklaas, Belgium, 9100
Centre Hospitalier de Wallonie picarde - site IMC Not yet recruiting
Tournai, Belgium, 7500
CHPLT Active, not recruiting
Verviers, Belgium, 4800
CHU Mont-Godinne Active, not recruiting
Yvoir, Belgium, 5530
Sponsors and Collaborators
Teva Pharma
Investigators
Principal Investigator: Christel Fontaine, MD University Hospital, Brussels
  More Information

No publications provided

Responsible Party: Teva Pharma
ClinicalTrials.gov Identifier: NCT01555944     History of Changes
Other Study ID Numbers: MyCard
Study First Received: March 14, 2012
Last Updated: October 16, 2012
Health Authority: Belgium: Ethics Committee

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 31, 2014