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Breast Cancer Tumor Care Observational Programme

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00660244
First Posted: April 17, 2008
Last Update Posted: June 6, 2012
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.
Information provided by (Responsible Party):
AstraZeneca
  Purpose
The purpose of this study is to investigate efficacy and tolerability under anastrozole (Arimidex) treatment.

Condition Intervention
Post Menopausal Arthralgia Drug: anastrozole

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Breast Cancer Tumor Care Patient Observation Programme

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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

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

Enrollment: 150
Study Start Date: February 2008
Study Completion Date: December 2009
Groups/Cohorts Assigned Interventions
1 Drug: anastrozole
Oral
Other Name: Arimidex

  Eligibility

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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Premenopausal women
  • Tamoxifen switch patients
  Contacts and Locations
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


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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00660244     History of Changes
Other Study ID Numbers: NIS-OAT-ARI-2007/1
First Submitted: April 15, 2008
First Posted: April 17, 2008
Last Update Posted: June 6, 2012
Last Verified: June 2012

Keywords provided by AstraZeneca:
Arimidex
Post menopausal
arthralgia

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