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Management of Metastatic Breast Cancer in Clinical Practice - Retrospective Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01715155
First received: October 22, 2012
Last updated: August 21, 2013
Last verified: August 2013

October 22, 2012
August 21, 2013
December 2012
June 2013   (final data collection date for primary outcome measure)
Number of progression events on a per patient-year-basis [ Time Frame: Up to 2 years 5 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01715155 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Management of Metastatic Breast Cancer in Clinical Practice - Retrospective Study
A Retrospective Cohort Study on Therapeutic Management of Metastatic Breast Cancer in Clinical Practice in Bulgaria

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.

A Retrospective Cohort Study on Therapeutic Management of Metastatic Breast Cancer in Clinical Practice in Bulgaria

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Probability Sample

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.

Metastatic Breast Cancer
Not Provided
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
171
June 2013
June 2013   (final data collection date for primary outcome measure)

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).
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria
 
NCT01715155
NIS-OBG-XXX-2012/1
No
AstraZeneca
AstraZeneca
Not Provided
Not Provided
AstraZeneca
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP