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Management of Metastatic Breast Cancer in Clinical Practice - Retrospective Study
This study has been completed.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01715155
First received: October 22, 2012
Last updated: August 21, 2013
Last verified: August 2013
| Tracking Information | |||
|---|---|---|---|
| First Received Date ICMJE | October 22, 2012 | ||
| Last Updated Date | August 21, 2013 | ||
| Start Date ICMJE | December 2012 | ||
| Primary Completion Date | June 2013 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
Number of progression events on a per patient-year-basis [ Time Frame: Up to 2 years 5 months ] | ||
| Original Primary Outcome Measures ICMJE | Same as current | ||
| Change History | Complete list of historical versions of study NCT01715155 on ClinicalTrials.gov Archive Site | ||
| Current Secondary Outcome Measures ICMJE |
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| 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 | Management of Metastatic Breast Cancer in Clinical Practice - Retrospective Study | ||
| Official Title ICMJE | A Retrospective Cohort Study on Therapeutic Management of Metastatic Breast Cancer in Clinical Practice in Bulgaria | ||
| Brief Summary | The purpose of this study is to evaluate the incidence rate of progression of disease, to describe the diagnostic and clinical management in patients with Metastatic Breast Cancer in the clinical practice in Bulgaria. | ||
| Detailed Description | A Retrospective Cohort Study on Therapeutic Management of Metastatic Breast Cancer in Clinical Practice in Bulgaria | ||
| 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 | Patients newly diagnosed with breast cancer (according to ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage. | ||
| Condition ICMJE | Metastatic Breast Cancer | ||
| Intervention ICMJE | Not Provided | ||
| Study Groups/Cohorts | Female patients diagnosed with metastatic breast cancer
Patients newly diagnosed with metastatic breast cancer, either De Novo or having progressed from a non-metastatic stage. |
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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 | 171 | ||
| Completion Date | June 2013 | ||
| Primary Completion Date | June 2013 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Senior) | ||
| Accepts Healthy Volunteers | No | ||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries ICMJE | Bulgaria | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number ICMJE | NCT01715155 | ||
| Other Study ID Numbers ICMJE | NIS-OBG-XXX-2012/1 | ||
| Has Data Monitoring Committee | No | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement | Not Provided | ||
| Responsible Party | AstraZeneca | ||
| Study Sponsor ICMJE | AstraZeneca | ||
| Collaborators ICMJE | Not Provided | ||
| Investigators ICMJE | Not Provided | ||
| PRS Account | AstraZeneca | ||
| Verification Date | August 2013 | ||
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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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