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

An observational study of Metastatic Breast Cancer, run by Teva Pharma at 24 sites in Belgium.

Completed

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

Trial 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)… Read more about this study

Who is it for?: Ages 65 years and older, women only
Conditions the study is for: Metastatic Breast Cancer
How many people: 60 participants
Where: 24 sitesBelgium
Study dates: Feb 2012to Apr 2016
Phase: Observational
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 65 years and older
Women only
No healthy volunteers
Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

24 sites in 1 country.

City, postcode or hospital

24 sites in 1 country

Belgium24 sites

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

Other trials in Belgium

About this study

Official title: 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:

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

Read the 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.

Conditions: Metastatic Breast Cancer
Medical subject headings: Breast Neoplasms

What is being measured

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

cardiovascular risk factors
Measured: 15 months

Timeline

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

Feb 2012Apr 2016

First posted16 Mar 2012 (estimated)
Study startFeb 2012
Primary completionApr 2016
Study completionApr 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01555944
Sponsor's protocol ID: MyCard
Status last verified: Apr 2016
First submitted: 14 Mar 2012
Last updated: 25 Apr 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
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Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
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RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma

All Metastatic Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Screening and Management of Cardiovascular Risk in Belgian Women Aged > or = 65 Years With Metastatic Breast Cancer Before and After Anthracycline Treatment
ClinicalTrials.gov ID: NCT01555944
Acronym / sponsor ID: MyCard
Conditions: Metastatic Breast Cancer
Study type: Observational
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Teva PharmaIndustry (pharma, biotech, devices)
Study start: Feb 2012
Primary completion: Apr 2016 (actual)
Study completion: Apr 2016 (actual)
First posted: 16 Mar 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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 design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 65 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Older adult
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.

Key inclusion criteria (6 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

cardiovascular risk factors
Time frame: 15 months

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2016.
Individual participant dataSharing planned: No

Related trials for Metastatic Breast Cancer

RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christel Fontaine, MD principal investigator

Universitair Ziekenhuis Brussel

24 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Metastatic Breast Cancer, run by Teva Pharma at 24 sites 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 6 inclusion and 7 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 25 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites 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.

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?

cardiovascular risk factors (time frame: 15 months). 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 NCT01555944.

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 25 Apr 2016.