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Clinical Trials/NCT01715155
NCT01715155
Completed
Not Applicable

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

AstraZeneca2 sites in 1 country171 target enrollmentDecember 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Metastatic Breast Cancer
Sponsor
AstraZeneca
Enrollment
171
Locations
2
Primary Endpoint
Number of progression events on a per patient-year-basis
Status
Completed
Last Updated
12 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
December 2012
End Date
June 2013
Last Updated
12 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

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
  • 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).

Outcomes

Primary Outcomes

Number of progression events on a per patient-year-basis

Time Frame: Up to 2 years 5 months

Secondary Outcomes

  • Proportion of patients among study population who have not progressed at 12 and 18 months after they were diagnosed(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(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(Up to 2 years 5 months)

Study Sites (2)

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