Quality of Life Analysis of Arimidex Treatment in Postmenopausal Patients With Breast Cancer - Full Text View

Quality of Life Analysis of Arimidex Treatment in Postmenopausal Patients With Breast Cancer (RADAR II E)

This study is ongoing, but not recruiting participants.

First Received: June 5, 2008 Last Updated: July 22, 2009 History of Changes

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00692289

Purpose

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

Condition
Breast Cancer

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Quality of Life Analysis of Arimidex Treatment in Postmenopausal Patients With Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Elements of the investigator questionnaire SF RAND-36 questionnaire [ Time Frame: Quarterly (plus or minus 3 days ) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Investigator Assessment Report [ Time Frame: Yearly (plus or minus 1 week ) ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	1510
Study Start Date:	May 2007
Estimated Study Completion Date:	July 2010

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Postmenopausal, hormonreceptor positive patients with early breast cancer treated with Arimidex (in accordance with the local SmPC).

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00692289

Locations

Hungary
Research Site
Miskolc, Hungary
Research Site
Zalaegerszeg, Hungary
Research Site
Budapest, Hungary
Research Site
Budapest, Hungary
Research Site
Miskolc, Hungary
Research Site
Mohacs, Hungary
Research Site
Vac, Hungary
Research Site
Komlo, Hungary

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	Zsolt Horváth, M.D.	National Institute of Oncology
Study Director:	Csaba Csongvai	AstraZeneca Hungary
Study Chair:	Éva Gulyás	AstraZeneca Hungary

More Information

No publications provided

Responsible Party:	AstraZeneca ( Francisco Sapunar )
Study ID Numbers:	NIS-OHU-ARI-2007/1
Study First Received:	June 5, 2008
Last Updated:	July 22, 2009
ClinicalTrials.gov Identifier:	NCT00692289 History of Changes
Health Authority:	Hungary: National Institute of Pharmacy

Keywords provided by AstraZeneca:

Quality of Life

Study placed in the following topic categories:

Anastrozole
Skin Diseases
Quality of Life
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on September 11, 2009