Observational Usage Study of Faslodex in Patients Suffering From Initial Breast Cancer in France

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00681369

First received: May 20, 2008

Last updated: January 21, 2011

Last verified: January 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

May 20, 2008

Last Updated Date

January 21, 2011

Start Date ^ICMJE

May 2007

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Evaluate Faslodex therapeutic strategy and treatment duration [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]
Describe the characteristics of patients treated with Faslodex [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00681369 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Observational Usage Study of Faslodex in Patients Suffering From Initial Breast Cancer in France

Official Title ^ICMJE

Observational Usage Study of Faslodex in Patients Suffering From Initial Breast Cancer in France

Brief Summary

the purpose of this study is to describe the way Faslodex is used in France, in patients suffering from initial breast cancer, that is to evaluate Faslodex treatment duration and to determine patients profile

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Retrospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

Hospital sample

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Patients suffering from initial breast cancer, treated with Faslodex, treatment which was stopped during 2007

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

217

Completion Date

June 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients suffering from initial breast cancer, treated with Faslodex, treatment which was stopped during 2007

Gender

Female

Ages

Child, Adult, Senior

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Not Provided

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00681369

Other Study ID Numbers ^ICMJE

NIS-OFR-FAS-2007/1

Has Data Monitoring Committee

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Francisco Sapunar - Medical Science Director, AstraZeneca

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Alain FLINOIS

TNS Healthcare - France138, avenue Marx Dormoy92120 Montrouge

Information Provided By

AstraZeneca

Verification Date

January 2011

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

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