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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00692289
First received: June 5, 2008
Last updated: June 5, 2012
Last verified: June 2012
  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: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quality of Life Analysis of Arimidex Treatment in Postmenopausal Patients With Breast Cancer

Resource links provided by NLM:


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 ]

Enrollment: 1510
Study Start Date: June 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Hungary
Research Site
Budapest, Hungary
Research Site
Komlo, Hungary
Research Site
Miskolc, Hungary
Research Site
Mohacs, Hungary
Research Site
Vac, Hungary
Research Site
Zalaegerszeg, 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
ClinicalTrials.gov Identifier: NCT00692289     History of Changes
Other Study ID Numbers: NIS-OHU-ARI-2007/1
Study First Received: June 5, 2008
Last Updated: June 5, 2012
Health Authority: Hungary: National Institute of Pharmacy

Keywords provided by AstraZeneca:
Quality of Life

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

ClinicalTrials.gov processed this record on September 22, 2014