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

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

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Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

65 year and older

Sex eligibility

Female

Study type

Observational

Primary location

ZNA Middelheim, Antwerp, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

cardiovascular risk factors

Time frame: 15 months

Sponsors and collaborators

Lead sponsor

Teva Pharma

Industry

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2016
Study completion: 2016
First posted: Mar 16, 2012
Registry last updated: Apr 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed