Ax-003/Arimidex (Anastrozole) in the Adjuvant Therapy of Early Breast Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

March 13, 2008

Last Updated Date

March 19, 2008

Start Date ^ICMJE

May 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

evaluation of Anastrozole therapy as adjuvant treatment in post.menopausal women with not advanced breast cancer únder naturalistic conditions [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00638391 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

description of population treated with anastrozole [ Time Frame: 12 months ] [ Designated as safety issue: No ]
further information about the change of specific laboratory parameters [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Ax-003/Arimidex (Anastrozole) in the Adjuvant Therapy of Early Breast Cancer

Official Title ^ICMJE

Postmenopausal Women With Early Hormone-Receptor Positive Breast Cancer/no Metastasis

Brief Summary

The purpose of this study is the initial/followed by 5 year adjuvant therapy with Anastrozole.

Detailed Description

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Case-Only, Prospective

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Drug: Anastrozole

Study Arms / Comparison Groups

all patients treated with Anastrozole

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1600

Completion Date

March 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Postmenopausal women with early hormone receptor positive breast cancer/no metastasis

Exclusion Criteria:

None

Gender

Female

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00638391

Responsible Party

Francisco Sapunar - Medical Science Director, AstraZeneca

Study ID Numbers ^ICMJE

Ax-003, Ax-003/Arimidex

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

H Brasch

AstraZeneca Germany

Information Provided By

AstraZeneca

Verification Date

March 2008

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