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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00692289
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : June 6, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief 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

Condition or disease
Breast Cancer

Study Type : Observational
Actual Enrollment : 1510 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quality of Life Analysis of Arimidex Treatment in Postmenopausal Patients With Breast Cancer
Study Start Date : June 2008
Primary Completion Date : July 2010
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Anastrozole
U.S. FDA Resources




Primary Outcome Measures :
  1. Elements of the investigator questionnaire SF RAND-36 questionnaire [ Time Frame: Quarterly (plus or minus 3 days ) ]

Secondary Outcome Measures :
  1. Investigator Assessment Report [ Time Frame: Yearly (plus or minus 1 week ) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00692289     History of Changes
Other Study ID Numbers: NIS-OHU-ARI-2007/1
First Posted: June 6, 2008    Key Record Dates
Last Update Posted: June 6, 2012
Last Verified: June 2012

Keywords provided by AstraZeneca:
Quality of Life

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Anastrozole
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs