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Breast Cancer Tumor Care Observational Programme

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00660244
Collaborator
(none)
150
Enrollment
1
Location
22
Duration (Months)
6.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

Study Design

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 :
Feb 1, 2008
Actual Study Completion Date :
Dec 1, 2009

Arms and Interventions

Arm Intervention/Treatment
1

Drug: anastrozole
Oral
Other Names:
  • Arimidex

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression of disease and tolerability in general [Baseline, every 3 month]

    Secondary Outcome Measures

    1. Patient questionnaire to collect data on Incidence, time of onset and treatment of arthralgia [Baseline, every 3 month]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Research Site Graz Austria

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Study Chair: Dr. Melichart, Hospital Rudolfstiftung
    • Study Chair: Dr. Feistauer, AKH-Vienna

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT00660244
    Other Study ID Numbers:
    • NIS-OAT-ARI-2007/1
    First Posted:
    Apr 17, 2008
    Last Update Posted:
    Jun 6, 2012
    Last Verified:
    Jun 1, 2012
    Keywords provided by AstraZeneca
    Arimidex
    Post menopausal
    arthralgia
    Additional relevant MeSH terms:
    Arthralgia
    Anastrozole

    Study Results

    No Results Posted as of Jun 6, 2012