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

This study has been completed.

First Received on March 13, 2008. Last Updated on March 19, 2008 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00638391

Purpose

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

Condition	Intervention
Breast Cancer	Drug: Anastrozole

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Postmenopausal Women With Early Hormone-Receptor Positive Breast Cancer/no Metastasis

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Anastrozole

U.S. FDA Resources

Further study details as provided by AstraZeneca:

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 ]

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 ]

Groups/Cohorts	Assigned Interventions
1 all patients treated with Anastrozole	Drug: Anastrozole Other Name: Arimidex

Eligibility

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00638391

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

H Brasch

AstraZeneca Germany

More Information

No publications provided

Responsible Party:	Francisco Sapunar - Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier:	NCT00638391 History of Changes
Other Study ID Numbers:	Ax-003, Ax-003/Arimidex
Study First Received:	March 13, 2008
Last Updated:	March 19, 2008
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:

Primary early MCa
Arimidex

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Anastrozole
Antineoplastic Agents, Hormonal

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012