Clinical trial NCT01555944: Prospective Observational Study in Patients With Metastatic Breast Cancer Treated With Anthracyclines
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Breast Cancer
Lead sponsor: Teva Pharma
Sponsor class: INDUSTRY
First posted: 2012-03-16
Enrollment: 60
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: cardiovascular risk factors
timeFrame: 15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: ZNA Middelheim
city: Arlon
country: Belgium
facility: Cliniques du Sud Lux - St Joseph
city: Bonheiden
country: Belgium
facility: Imelda
city: Bouge
country: Belgium
facility: Clinique Saint-Luc
city: Brasschaat
country: Belgium
facility: AZ KLINA
city: Brugge
country: Belgium
facility: AZ St Jan
city: Brussels
country: Belgium
facility: CHU Brugmann
city: Brussels
country: Belgium
facility: Erasme
city: Brussels
country: Belgium
facility: CHIREC - Centre Hospitalier Interrégional Edith Cavell
city: Brussel
country: Belgium
facility: UZ Brussel
city: Chimay
country: Belgium
facility: CSF
city: Duffel
country: Belgium
facility: AZ St-Maarten
city: Edegem
country: Belgium
facility: UZA
city: Geel
country: Belgium
facility: AZ St-Dimpna
city: Ghent
country: Belgium
facility: AZ St-Lucas
city: Merksem
country: Belgium
facility: ZNA Jan Palfijn
city: Namur
country: Belgium
facility: CHR
city: Namur
country: Belgium
facility: CMSE
city: Oostende
country: Belgium
facility: AZ Damiaan
city: Ottignies
country: Belgium
facility: Clinique St Pierre
city: St-Niklaas
country: Belgium
facility: AZ Nikolaas
city: Tournai
country: Belgium
facility: Centre Hospitalier de Wallonie picarde - site IMC
city: Verviers
country: Belgium
facility: CHPLT
city: Yvoir
country: Belgium
facility: CHU Mont-Godinne
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Christel Fontaine, MD
role: PRINCIPAL_INVESTIGATOR
References: