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CompletedNCT00880711FIONAUpdated Nov 30, 2011

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

An observational study in Breast Cancer, sponsored by AstraZeneca. Completed at 13 sites in Austria. Open to female participants. Per ClinicalTrials.gov, last updated 2011-11-30.

Sponsored by AstraZeneca · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
57
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Breast Cancer

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Keywords

  • Fiona
  • Faslodex
  • Advanced Breast Cancer
  • Real life data
  • Collect real life data in clinical practice across Austria
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 57 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Hospitals, office based specialists

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

Exclusion Criteria:

  • A subject who does not fulfil all the above mentioned inclusion criteria is not allowed to participate in this NIS
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
57 participants (actual)

Groups and cohorts

  • 1

    Patient with advanced BC, already receiving Faslodex therapy

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Tolerability

    Time frame: After 3, 6, 9 month (as per usual clinical practice)

  2. Quality of Life

    Time frame: Baseline, after 3, 6, 9 month (as per usual clinical practice)

  3. Performance status (Karnofsky Index)

    Time frame: Baseline, after 3, 6, 9 month (as per usual clinical practice)

07

Study locations

13 sites
  • Research Site
    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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00880711
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Apr 14, 2009
Start date
Apr 2009
Primary completion
Sep 2010
Completion
Dec 2010
Last update
Nov 30, 2011

Study contacts

Guenther Steger, Univ Prof. Dr.
study chair · Medical University of Vienna

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.

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