Breast Cancer Tumor Care Observational Programme

Arthralgia Clinical Trial

Official title:

Breast Cancer Tumor Care Patient Observation Programme

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00660244
• Other study ID #: NIS-OAT-ARI-2007/1
• Status: Completed
• Phase: N/A
• First received: April 15, 2008
• Last updated: June 5, 2012
• Start date: February 2008
• Est. completion date: December 2009

Study information

• Verified date: June 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to investigate efficacy and tolerability under anastrozole (Arimidex) treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Postmenopausal women

• Already on upfront Arimidex Therapy (Start 1-4 weeks before)

• HR+

Exclusion Criteria:

• Premenopausal women

• Tamoxifen switch patients

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthralgia
• Post Menopausal

Intervention

Drug:
• anastrozole
Oral

Locations

Country	Name	City	State
Austria	Research Site	Graz

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression of disease and tolerability in general		Baseline, every 3 month	No
Secondary	Patient questionnaire to collect data on Incidence, time of onset and treatment of arthralgia		Baseline, every 3 month	No