Prospective Observational Study in Patients With Metastatic Breast Cancer Treated With Anthracyclines
This study is currently recruiting participants.
Verified October 2012 by Teva Pharma
Sponsor:
Teva Pharma
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
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Purpose
This is an open, multicentre, prospective observational (non-interventional) study, performed in Belgium.
Principal objectives:
- 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
- To observe the management of cardiovascular risk during and after anthracycline treatment
- To compare liposomal versus non-liposomal anthracycline therapy (ratio 1:1) on cardiac function, outcome and quality of life (EORTC QLQ-C30)
Secondary objectives:
- 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)
- To evaluate cardiovascular event type: ECG changes, arrhythmia, decrease of ejection fraction, heart failure and rate according to allocated treatment.
- 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
- To correlate the therapeutic choice and posology of anthracyclines for MBC with Cardiovascular risk at baseline
- 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) |
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
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 May 21, 2013