Faslodex International Observational Non-Interventional Study in Advanced Breast Cancer (BC) (FIONA)

November 29, 2011 updated by: AstraZeneca

Faslodex International Observational Non-Interventional Study in Advanced Breast Cancer

The purpose is to collect real life data on the use of fulvestrant in normal clinical practice in Austria and document the clinical benefit of fulvestrant treatment.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

57

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria
        • Research Site
      • Innsbruck, Austria
        • Research Site
      • Klagenfurt, Austria
        • Research Site
      • Leoben, Austria
        • Research Site
      • Linz, Austria
        • Research Site
      • Oberpullendorf, Austria
        • Research Site
      • Rankweil, Austria
        • Research Site
      • Rottenmann, Austria
        • Research Site
      • Salzburg, Austria
        • Research Site
      • St. Veit, Austria
        • Research Site
      • Steyr, Austria
        • Research Site
      • Vienna, Austria
        • Research Site
      • Wr. Neustadt, Austria
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Hospitals, office based specialists

Description

Inclusion Criteria:

  • Postmenopausal women with hormone receptor-positive locally advanced or metastatic breast cancer
  • Ability to read and write and complete questionnaires
  • Provision of written informed consent
  • Patients who already received a prescription for fulvestrant

Exclusion Criteria:

  • A subject who does not fulfil all the above mentioned inclusion criteria is not allowed to participate in this NIS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Patient with advanced BC, already receiving Faslodex therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical Benefit, defined as the development of at least one of the following stages and holding on for at least 6 month: Complete response, partial response or stable disease
Time Frame: Baseline, after 3, 6, 9 month
Baseline, after 3, 6, 9 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Tolerability
Time Frame: After 3, 6, 9 month (as per usual clinical practice)
After 3, 6, 9 month (as per usual clinical practice)
Quality of Life
Time Frame: Baseline, after 3, 6, 9 month (as per usual clinical practice)
Baseline, after 3, 6, 9 month (as per usual clinical practice)
Performance status (Karnofsky Index)
Time Frame: Baseline, after 3, 6, 9 month (as per usual clinical practice)
Baseline, after 3, 6, 9 month (as per usual clinical practice)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Chair: Guenther Steger, Univ Prof. Dr., Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

April 10, 2009

First Submitted That Met QC Criteria

April 13, 2009

First Posted (Estimate)

April 14, 2009

Study Record Updates

Last Update Posted (Estimate)

November 30, 2011

Last Update Submitted That Met QC Criteria

November 29, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-OAT-FAS-2009/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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