Management of Metastatic Breast Cancer in Clinical Practice - Retrospective Study

Tracking Information
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; (submitted: October 24, 2012)	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; (submitted: October 24, 2012)	Proportion of patients among study population who have not progressed at 12 and 18 months after they were diagnosed [ Time Frame: Up to 2 years 5 months ]; Median and mean time interval that elapsed between diagnosis and first objective tumor progression (TTP) event and subsequent events [ Time Frame: Up to 2 years 5 months ]; Median and mean time from the date of diagnosis to the date of breast cancer progression or death whichever occurred first [ Time Frame: Up to 2 years 5 months ]
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
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.
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	Completed
Actual Enrollment; (submitted: August 21, 2013)	171
Original Estimated Enrollment; (submitted: October 24, 2012)	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: New diagnosis of breast cancer according to ICD-10 with confirmed metastasis; Confirmed diagnosis between 1st July 2010 and 30th June 2011.; Female patient managed for her disease at the same setting where final diagnosis of MBC was performed. Exclusion Criteria: History of concurrent or other primary malignancies (except curatively resected non-melanoma skin cancer or in situ cervical cancer).
Sex/Gender	Sexes Eligible for Study: Female
Ages	18 Years and older (Adult, Older Adult)
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