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

This study has been completed.

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

Sponsored by:	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:	Case-Only, 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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	1600
Study Start Date:	May 2005
Study Completion Date:	March 2007

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

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

None

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

Keywords provided by AstraZeneca:

Primary early MCa
Arimidex

Study placed in the following topic categories:

Anastrozole
Antineoplastic Agents, Hormonal
Skin Diseases
Adjuvants, Immunologic
Neoplasm Metastasis

Breast Neoplasms
Aromatase Inhibitors
Hormones
Breast Diseases

Additional relevant MeSH terms:

Anastrozole
Skin Diseases
Antineoplastic Agents, Hormonal
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Breast Neoplasms
Enzyme Inhibitors

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Aromatase Inhibitors
Breast Diseases

ClinicalTrials.gov processed this record on September 10, 2009