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

Tracking Information

First Received Date ^ICMJE

April 10, 2009

Last Updated Date

November 29, 2011

Start Date ^ICMJE

April 2009

Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00880711 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Faslodex International Observational Non-Interventional Study in Advanced Breast Cancer

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Hospitals, office based specialists

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Patient with advanced BC, already receiving Faslodex therapy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2010

Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Austria

Administrative Information

NCT Number ^ICMJE

NCT00880711

Other Study ID Numbers ^ICMJE

NIS-OAT-FAS-2009/1

Has Data Monitoring Committee

Responsible Party

AstraZeneca

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Guenther Steger, Univ Prof. Dr.

Medical University of Vienna

Information Provided By

AstraZeneca

Verification Date

November 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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