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NCT00692289 Clinical Trial

Quality of Life Analysis of Arimidex Treatment in Postmenopausal Patients With Breast Cancer

Breast Cancer Clinical Trial

— RADAR II E  

Official title:
Quality of Life Analysis of Arimidex Treatment in Postmenopausal Patients With Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00692289
Other study ID # NIS-OHU-ARI-2007/1
Secondary ID
Status Completed
Phase N/A
First received June 5, 2008
Last updated June 5, 2012
Start date June 2008
Est. completion date July 2010

Study information
Verified date June 2012
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Hungary: National Institute of Pharmacy
Study type Observational

Clinical Trial Summary

This is an open label, non-interventional quality of life analysis for Arimidex treated postmenopausal patients in early breast cancer by investigator's questionnaire

Recruitment information / eligibility
Status Completed
Enrollment 1510
Est. completion date July 2010
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- Provision of informed consent

- Postmenopausal, hormon receptor positive patients with early breast cancer treated with Arimidex

- Investigators are requested to recruit patients only with at least 1 month prior Arimidex treatment.

Exclusion Criteria:

- Allergy to substance of medication

- Pre-perimenopausal woman

- Woman not eligible for treatment

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Hungary Research Site Budapest
Hungary Research Site Komlo
Hungary Research Site Miskolc
Hungary Research Site Mohacs
Hungary Research Site Vac
Hungary Research Site Zalaegerszeg

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Hungary, 

Outcome
Type Measure Description Time frame Safety issue
Primary Elements of the investigator questionnaire SF RAND-36 questionnaire Quarterly (plus or minus 3 days ) No
Secondary Investigator Assessment Report Yearly (plus or minus 1 week ) No
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