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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: March 13, 2008
Last updated: March 19, 2008
Last verified: March 2008
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:

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 ]

Enrollment: 1600
Study Start Date: May 2005
Study Completion Date: March 2007
Groups/Cohorts Assigned Interventions
all patients treated with Anastrozole
Drug: Anastrozole
Other Name: Arimidex


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

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00638391

Sponsors and Collaborators
Study Director: H Brasch AstraZeneca Germany
  More Information

Responsible Party: Francisco Sapunar - Medical Science Director, AstraZeneca 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

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on April 27, 2016