The purpose of this study is to investigate efficacy and tolerability under anastrozole (Arimidex) treatment...
Date First Received: April 15, 2008
Last Updated: April 24, 2008
Verified by: AstraZeneca, April 2008
Clinical Trial Phase: N/A | Start Date: February 2008
Overall Status: Recruiting
Estimated Enrollment: 150
Brief Summary
Official Title: “Breast Cancer Tumor Care Patient Observation Programme”
Condition Keyword(s):
Intervention(s):
The purpose of this study is to investigate efficacy and tolerability under anastrozole (Arimidex) treatment.
Study Type: Observational
Study Design: Case-Only, Prospective
Intervention(s) in this Clinical Trial
- Drug: anastrozole
- Oral
Arms, Groups and Cohorts in this Clinical Trial
- : 1
Outcome Measures for this Clinical Trial
Primary Measures
- Progression of disease and tolerability in general
- Time Frame: Baseline, every 3 month
Safety Issue?: No
- Time Frame: Baseline, every 3 month
Secondary Measures
- Patient questionnaire to collect data on Incidence, time of onset and treatment of arthralgia
- Time Frame: Baseline, every 3 month
Safety Issue?: No
- Time Frame: Baseline, every 3 month
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Postmenopausal women
- Already on upfront Arimidex Therapy (Start 1-4 weeks before)
- HR+
Exclusion Criteria:
- Premenopausal women
- Tamoxifen switch patients
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: AstraZeneca
Overall Clinical Trial Officials and Contacts
Dr. Melichart Study Chair Hospital Rudolfstiftung
Overall Contact: AstraZeneca Austria Clinical Study Information +43 1 71131 262 alexandra.jaeger@astrazeneca.com
Additional Information
Information obtained from ClinicalTrials.gov on November 20, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00660244
Study ID Number: NIS-OAT-ARI-2007/1
ClinicalTrials.gov Identifier: NCT00660244
Health Authority: Austria: Agency for Health and Food Safety
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
