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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00880711
First received: April 10, 2009
Last updated: November 29, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Faslodex International Observational Non-Interventional Study in Advanced Breast Cancer

Resource links provided by NLM:

Drug Information available for: Fulvestrant
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerability [ Time Frame: After 3, 6, 9 month (as per usual clinical practice) ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: Baseline, after 3, 6, 9 month (as per usual clinical practice) ] [ Designated as safety issue: No ]
  • Performance status (Karnofsky Index) [ Time Frame: Baseline, after 3, 6, 9 month (as per usual clinical practice) ] [ Designated as safety issue: No ]

Enrollment: 57
Study Start Date: April 2009
Study Completion Date: December 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patient with advanced BC, already receiving Faslodex therapy

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hospitals, office based specialists

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00880711

Locations
Austria
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
Sponsors and Collaborators
AstraZeneca
Investigators
Study Chair: Guenther Steger, Univ Prof. Dr. Medical University of Vienna
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00880711     History of Changes
Other Study ID Numbers: NIS-OAT-FAS-2009/1
Study First Received: April 10, 2009
Last Updated: November 29, 2011
Health Authority: Austria: Ethikkommission

Keywords provided by AstraZeneca:
Fiona
Faslodex
Advanced Breast Cancer
Real life data
Collect real life data in clinical practice across Austria

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Antineoplastic Agents
Therapeutic Uses
 Pharmacologic Actions
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on June 18, 2013