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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00638391
First Posted: March 19, 2008
Last Update Posted: March 20, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  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:


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 ]

Secondary Outcome Measures:
  • description of population treated with anastrozole [ Time Frame: 12 months ]
  • further information about the change of specific laboratory parameters [ Time Frame: 12 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00638391


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

Responsible Party: Francisco Sapunar - Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00638391     History of Changes
Other Study ID Numbers: Ax-003
Ax-003/Arimidex
First Submitted: March 13, 2008
First Posted: March 19, 2008
Last Update Posted: March 20, 2008
Last Verified: March 2008

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
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs