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

Metastatic Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01555944
• Other study ID #: MyCard
• Status: Completed
• Phase: N/A
• First received: March 14, 2012
• Last updated: April 22, 2016
• Start date: February 2012
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: Teva Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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) 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Locations

Country	Name	City	State
Belgium	ZNA Middelheim	Antwerp
Belgium	Cliniques du Sud Lux - St Joseph	Arlon
Belgium	Imelda	Bonheiden
Belgium	Clinique Saint-Luc	Bouge
Belgium	AZ KLINA	Brasschaat
Belgium	AZ St Jan	Brugge
Belgium	UZ Brussel	Brussel
Belgium	CHIREC - Centre Hospitalier Interrégional Edith Cavell	Brussels
Belgium	CHU Brugmann	Brussels
Belgium	Erasme	Brussels
Belgium	CSF	Chimay
Belgium	AZ St-Maarten	Duffel
Belgium	UZA	Edegem
Belgium	AZ St-Dimpna	Geel
Belgium	AZ St-Lucas	Ghent
Belgium	ZNA Jan Palfijn	Merksem
Belgium	CHR	Namur
Belgium	CMSE	Namur
Belgium	AZ Damiaan	Oostende
Belgium	Clinique St Pierre	Ottignies
Belgium	AZ Nikolaas	St-Niklaas
Belgium	Centre Hospitalier de Wallonie picarde - site IMC	Tournai
Belgium	CHPLT	Verviers
Belgium	CHU Mont-Godinne	Yvoir

Sponsors (1)

Lead Sponsor	Collaborator
Teva Pharma

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiovascular risk factors		15 months