Breast Cancer Tumor Care Observational Programme
This study has been completed.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00660244
First received: April 15, 2008
Last updated: June 5, 2012
Last verified: June 2012
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | April 15, 2008 | ||||||||
| Last Updated Date | June 5, 2012 | ||||||||
| Start Date ICMJE | February 2008 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
Progression of disease and tolerability in general [ Time Frame: Baseline, every 3 month ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00660244 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Breast Cancer Tumor Care Observational Programme | ||||||||
| Official Title ICMJE | Breast Cancer Tumor Care Patient Observation Programme | ||||||||
| Brief Summary | The purpose of this study is to investigate efficacy and tolerability under anastrozole (Arimidex) treatment. |
||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Postmenopausal women |
||||||||
| Condition ICMJE |
|
||||||||
| Intervention ICMJE | Drug: anastrozole
Oral
Other Name: Arimidex |
||||||||
| Study Group/Cohort (s) | 1
Intervention: Drug: anastrozole |
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 150 | ||||||||
| Completion Date | December 2009 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Female | ||||||||
| Ages | Not Provided | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Austria | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00660244 | ||||||||
| Other Study ID Numbers ICMJE | NIS-OAT-ARI-2007/1 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | AstraZeneca | ||||||||
| Study Sponsor ICMJE | AstraZeneca | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | AstraZeneca | ||||||||
| Verification Date | June 2012 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||