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Breast Cancer Tumor Care Observational Programme

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ClinicalTrials.gov Identifier: NCT00660244
Recruitment Status : Completed
First Posted : April 17, 2008
Last Update Posted : June 6, 2012
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Post Menopausal Arthralgia Drug: anastrozole

Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Breast Cancer Tumor Care Patient Observation Programme
Study Start Date : February 2008
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Anastrozole
U.S. FDA Resources

Group/Cohort Intervention/treatment
1 Drug: anastrozole
Other Name: Arimidex

Primary Outcome Measures :
  1. Progression of disease and tolerability in general [ Time Frame: Baseline, every 3 month ]

Secondary Outcome Measures :
  1. Patient questionnaire to collect data on Incidence, time of onset and treatment of arthralgia [ Time Frame: Baseline, every 3 month ]

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 women

Inclusion Criteria:

  • Postmenopausal women
  • Already on upfront Arimidex Therapy (Start 1-4 weeks before)
  • HR+

Exclusion Criteria:

  • Premenopausal women
  • Tamoxifen switch patients

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): NCT00660244

Research Site
Graz, Austria
Sponsors and Collaborators
Study Chair: Dr. Melichart Hospital Rudolfstiftung
Study Chair: Dr. Feistauer AKH-Vienna

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00660244     History of Changes
Other Study ID Numbers: NIS-OAT-ARI-2007/1
First Posted: April 17, 2008    Key Record Dates
Last Update Posted: June 6, 2012
Last Verified: June 2012

Keywords provided by AstraZeneca:
Post menopausal

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
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