Breast Cancer Tumor Care Observational Programme

June 5, 2012 updated by: AstraZeneca

Breast Cancer Tumor Care Patient Observation Programme

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Postmenopausal women

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Premenopausal women
  • Tamoxifen switch patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Drug: anastrozole
Oral
Other Names:
  • Arimidex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression of disease and tolerability in general
Time Frame: Baseline, every 3 month
Baseline, every 3 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient questionnaire to collect data on Incidence, time of onset and treatment of arthralgia
Time Frame: Baseline, every 3 month
Baseline, every 3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

April 15, 2008

First Submitted That Met QC Criteria

April 15, 2008

First Posted (Estimate)

April 17, 2008

Study Record Updates

Last Update Posted (Estimate)

June 6, 2012

Last Update Submitted That Met QC Criteria

June 5, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-OAT-ARI-2007/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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