Epidemiology and Therapeutic Management of Metastatic Breast Cancer in Romania: A Retrospective Cohort Study

AstraZeneca15 sites in 1 country128 target enrollmentJanuary 2013

ConditionsBreast Cancer Nos Metastatic Recurrent

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer Nos Metastatic Recurrent
Sponsor: AstraZeneca
Enrollment: 128
Locations: 15
Primary Endpoint: The incidence rate of progression of disease in a cohort of patients newly diagnosed with MBC, either De Novo or having progressed from a non-metastatic stage
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multicenter, national, retrospective chart-review study that will be based on the collection of data from electronical or paper-based medical records with available data on female patients diagnosed with metastatic brest cancer . The main purpose of this study is to provide accurate, evidence based description on the incidence of progression of metastatic breast cancer and its clinical management.

Detailed Description

Epidemiology and Therapeutic Management of Metastatic Breast Cancer in Romania: A retrospective cohort study

Registry

clinicaltrials.gov

Start Date

January 2013

End Date

June 2013

Last Updated

12 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Female aged 18 years and over Diagnosis of breast cancer according to ICD-10 diagnostic criteria with confirmed metastasis
•Confirmed diagnosis between 1st July 2010 - 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)

Outcomes

Primary Outcomes

The incidence rate of progression of disease in a cohort of patients newly diagnosed with MBC, either De Novo or having progressed from a non-metastatic stage

Time Frame: At 12 and 18 months after diagnosis

Secondary Outcomes

The progression free survival (PFS) rates(At 12 and 18 months after diagnosis)
The progression free survival (PFS) time(At 18 months after diagnosis)
Time to progression (TTP)(At 18 months after diagnosis)
The clinical and pathological characteristics of newly diagnosed MBC patients(At 18 months after diagnosis)
The socio-demographic and anthropometric characteristics of newly diagnosed MBC patients(At 18 months after diagnosis)
Health care utilization associated with the disease in Romania(At 18 months after diagnosis)