Breast Cancer Tumor Care Observational Programme

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00660244
First received: April 15, 2008
Last updated: June 5, 2012
Last verified: June 2012
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient questionnaire to collect data on Incidence, time of onset and treatment of arthralgia [ Time Frame: Baseline, every 3 month ] [ Designated as safety issue: No ]

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

  Eligibility

Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00660244     History of Changes
Other Study ID Numbers: NIS-OAT-ARI-2007/1
Study First Received: April 15, 2008
Last Updated: June 5, 2012
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by AstraZeneca:
Arimidex
Post menopausal
arthralgia

Additional relevant MeSH terms:
Breast Neoplasms
Arthralgia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014