Management of Metastatic Breast Cancer in Clinical Practice - Retrospective Study

Metastatic Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01715155
• Other study ID #: NIS-OBG-XXX-2012/1
• Status: Completed
• Phase: N/A
• First received: October 22, 2012
• Last updated: August 21, 2013
• Start date: December 2012
• Est. completion date: June 2013

Study information

• Verified date: August 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bulgaria: Bulgarian Drug Agency
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Locations

Country	Name	City	State
Bulgaria	Research Site	Pleven
Bulgaria	Research Site	Plovdiv
Bulgaria	Research Site	Ruse
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Stara Zagora
Bulgaria	Reaseach Site	Varna

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of progression events on a per patient-year-basis		Up to 2 years 5 months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No