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

March 19, 2008 updated by: AstraZeneca

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1600

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
all patients treated with Anastrozole
Drug: Anastrozole
Other Names:
  • Arimidex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
evaluation of Anastrozole therapy as adjuvant treatment in post.menopausal women with not advanced breast cancer únder naturalistic conditions
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
description of population treated with anastrozole
Time Frame: 12 months
12 months
further information about the change of specific laboratory parameters
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: H Brasch, AstraZeneca Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion

December 7, 2022

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

March 13, 2008

First Submitted That Met QC Criteria

March 18, 2008

First Posted (Estimate)

March 19, 2008

Study Record Updates

Last Update Posted (Estimate)

March 20, 2008

Last Update Submitted That Met QC Criteria

March 19, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ax-003
  • Ax-003/Arimidex

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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