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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00638391
First received: March 13, 2008
Last updated: March 19, 2008
Last verified: March 2008
History of Changes
  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:

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 ]

Enrollment: 1600
Study Start Date: May 2005
Study Completion Date: March 2007
Groups/Cohorts Assigned Interventions
1
all patients treated with Anastrozole
 Drug: Anastrozole
Other Name: Arimidex

  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: 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 May 16, 2013