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

Breast Cancer Clinical Trial

— FIONA  

Official title:

Faslodex International Observational Non-Interventional Study in Advanced Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00880711
• Other study ID #: NIS-OAT-FAS-2009/1
• Status: Completed
• Phase: N/A
• First received: April 10, 2009
• Last updated: November 29, 2011
• Start date: April 2009
• Est. completion date: December 2010

Study information

• Verified date: November 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: December 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Baseline, after 3, 6, 9 month	No
Secondary	Tolerability		After 3, 6, 9 month (as per usual clinical practice)	No
Secondary	Quality of Life		Baseline, after 3, 6, 9 month (as per usual clinical practice)	No
Secondary	Performance status (Karnofsky Index)		Baseline, after 3, 6, 9 month (as per usual clinical practice)	No