Management of Metastatic Breast Cancer in Clinical Practice - Retrospective Study
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ClinicalTrials.gov Identifier: NCT01715155 |
Recruitment Status
:
Completed
First Posted
: October 26, 2012
Last Update Posted
: August 22, 2013
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Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
Tracking Information | |||
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First Submitted Date | October 22, 2012 | ||
First Posted Date | October 26, 2012 | ||
Last Update Posted Date | August 22, 2013 | ||
Study Start Date | December 2012 | ||
Actual Primary Completion Date | June 2013 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures |
Number of progression events on a per patient-year-basis [ Time Frame: Up to 2 years 5 months ] | ||
Original Primary Outcome Measures | Same as current | ||
Change History | Complete list of historical versions of study NCT01715155 on ClinicalTrials.gov Archive Site | ||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||
Current Other Outcome Measures | Not Provided | ||
Original Other Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title | Management of Metastatic Breast Cancer in Clinical Practice - Retrospective Study | ||
Official Title | 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 | Observational | ||
Study Design | 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 | Metastatic Breast Cancer | ||
Intervention | 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 | ||
* 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 | Completed | ||
Actual Enrollment |
171 | ||
Original Estimated Enrollment |
200 | ||
Actual Study Completion Date | June 2013 | ||
Actual Primary Completion Date | June 2013 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria | 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 | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries | Bulgaria | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number | NCT01715155 | ||
Other Study ID Numbers | 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 | AstraZeneca | ||
Collaborators | Not Provided | ||
Investigators | Not Provided | ||
PRS Account | AstraZeneca | ||
Verification Date | August 2013 |