Management of Metastatic Breast Cancer in Clinical Practice - Retrospective Study

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

ClinicalTrials.gov Identifier:

NCT01715155

First received: October 22, 2012

Last updated: April 29, 2013

Last verified: April 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	October 22, 2012
Last Updated Date	April 29, 2013
Start Date ^ICMJE	December 2012
Estimated Primary Completion Date	June 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 24, 2012)	Number of progression events on a per patient-year-basis [ Time Frame: Up to 2 years 5 months ] [ Designated as safety issue: No ]
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 (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 ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: No ] 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 ] [ 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	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
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 Group/Cohort (s)	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 ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	200
Estimated Completion Date	June 2013
Estimated Primary Completion Date	June 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: New diagnosis of breast cancer according to ICD-10 with confirmed metastasis Confirmed diagnosis between 1st October 2010 and 31st March 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).
Gender	Female
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Bulgaria

Administrative Information
NCT Number ^ICMJE	NCT01715155
Other Study ID Numbers ^ICMJE	NIS-OBG-XXX-2012/1
Has Data Monitoring Committee	No
Responsible Party	AstraZeneca
Study Sponsor ^ICMJE	AstraZeneca
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	AstraZeneca
Verification Date	April 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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