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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

March 13, 2008

Last Updated Date

March 19, 2008

Start Date ^†

May 2005

Current Primary Outcome Measures ^†

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 ^†

Same as current

Change History

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

Current Secondary Outcome Measures ^†

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 ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

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 ^†

Observational

Study Design ^†

Case-Only, Prospective

Condition ^†

Breast Cancer

Intervention ^†

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 ^†

Completed

Enrollment ^†

1600

Completion Date

March 2007

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

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

Exclusion Criteria:

None

Gender

Female

Ages

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00638391

Responsible Party

Francisco Sapunar - Medical Science Director, AstraZeneca

Secondary IDs ^††

Ax-003/Arimidex

Study Sponsor ^†

AstraZeneca

Collaborators ^††

Investigators ^†

Study Director:

H Brasch

AstraZeneca Germany

Information Provided By

AstraZeneca

Verification Date

March 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.