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

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. Identifier: NCT00638391
Recruitment Status : Completed
First Posted : March 19, 2008
Last Update Posted : March 20, 2008
Information provided by:

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

Condition or disease Intervention/treatment
Breast Cancer Drug: Anastrozole

Study Type : Observational
Actual Enrollment : 1600 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Postmenopausal Women With Early Hormone-Receptor Positive Breast Cancer/no Metastasis
Study Start Date : May 2005
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Anastrozole
U.S. FDA Resources

Group/Cohort Intervention/treatment
all patients treated with Anastrozole
Drug: Anastrozole
Other Name: Arimidex

Primary Outcome Measures :
  1. 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 :
  1. description of population treated with anastrozole [ Time Frame: 12 months ]
  2. further information about the change of specific laboratory parameters [ Time Frame: 12 months ]

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

Inclusion Criteria:

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

Exclusion Criteria:

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 identifier (NCT number): NCT00638391

Sponsors and Collaborators
Study Director: H Brasch AstraZeneca Germany

Responsible Party: Francisco Sapunar - Medical Science Director, AstraZeneca Identifier: NCT00638391     History of Changes
Other Study ID Numbers: Ax-003
First Posted: March 19, 2008    Key Record Dates
Last Update Posted: March 20, 2008
Last Verified: March 2008

Keywords provided by AstraZeneca:
Primary early MCa

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
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