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

Breast Cancer Clinical Trial

— Ax-003  

Official title:

Postmenopausal Women With Early Hormone-Receptor Positive Breast Cancer/no Metastasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00638391
• Other study ID #: Ax-003
• Secondary ID: Ax-003/Arimidex
• Status: Completed
• Phase: N/A
• First received: March 13, 2008
• Last updated: March 19, 2008
• Start date: May 2005
• Est. completion date: March 2007

Study information

• Verified date: March 2008
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1600
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Anastrozole

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluation of Anastrozole therapy as adjuvant treatment in post.menopausal women with not advanced breast cancer únder naturalistic conditions		12 months	No
Secondary	description of population treated with anastrozole		12 months	No
Secondary	further information about the change of specific laboratory parameters		12 months	No