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

NCT01555944 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2016-04-25

No results posted yet for this study

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

Conditions

Sponsors & Collaborators

  • Teva Pharma

    lead INDUSTRY

Principal Investigators

  • Christel Fontaine, MD · Universitair Ziekenhuis Brussel

Eligibility

Min Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • Belgium

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01555944 on ClinicalTrials.gov