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Observational Usage Study of Faslodex in Patients Suffering From Initial Breast Cancer in France
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00681369
First received: May 20, 2008
Last updated: January 21, 2011
Last verified: January 2011
| Tracking Information | ||||
|---|---|---|---|---|
| First Received Date ICMJE | May 20, 2008 | |||
| Last Updated Date | January 21, 2011 | |||
| Start Date ICMJE | May 2007 | |||
| Primary Completion Date | Not Provided | |||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | |||
| Change History | Complete list of historical versions of study NCT00681369 on ClinicalTrials.gov Archive Site | |||
| Current Secondary Outcome Measures ICMJE | Not Provided | |||
| Original Secondary Outcome Measures ICMJE | Not Provided | |||
| Current Other Outcome Measures ICMJE | Not Provided | |||
| Original Other Outcome Measures ICMJE | Not Provided | |||
| Descriptive Information | ||||
| Brief Title ICMJE | Observational Usage Study of Faslodex in Patients Suffering From Initial Breast Cancer in France | |||
| Official Title ICMJE | Observational Usage Study of Faslodex in Patients Suffering From Initial Breast Cancer in France | |||
| Brief Summary | the purpose of this study is to describe the way Faslodex is used in France, in patients suffering from initial breast cancer, that is to evaluate Faslodex treatment duration and to determine patients profile | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Observational | |||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Probability Sample | |||
| Study Population | Hospital sample | |||
| Condition ICMJE | Breast Cancer | |||
| Intervention ICMJE | Not Provided | |||
| Study Groups/Cohorts | 1
Patients suffering from initial breast cancer, treated with Faslodex, treatment which was stopped during 2007 |
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| Publications * | Not Provided | |||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Enrollment ICMJE | 217 | |||
| Completion Date | June 2007 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Sex/Gender |
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| Ages | Child, Adult, Senior | |||
| Accepts Healthy Volunteers | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Not Provided | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00681369 | |||
| Other Study ID Numbers ICMJE | NIS-OFR-FAS-2007/1 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| Plan to Share Data | Not Provided | |||
| IPD Description | Not Provided | |||
| Responsible Party | Francisco Sapunar - Medical Science Director, AstraZeneca | |||
| Study Sponsor ICMJE | AstraZeneca | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
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| PRS Account | AstraZeneca | |||
| Verification Date | January 2011 | |||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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