Epidemiology and Management of Metastatic Breast Cancer

Breast Cancer Nos Metastatic Recurrent Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01711502
• Other study ID #: NIS-ORO-XXX-2012/1
• Status: Completed
• Phase: N/A
• First received: October 18, 2012
• Last updated: January 29, 2014
• Start date: January 2013
• Est. completion date: June 2013

Study information

• Verified date: January 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: National Agency for Medicines and Medical DevicesRomania: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• 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:

• 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)

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Breast Cancer Nos Metastatic Recurrent
• Breast Neoplasms

Locations

Country	Name	City	State
Romania	Doina Coste Gherasim	Baia Mare
Romania	Daniel Ciurescu	Brasov
Romania	Dana Lucia Stanculeanu	Bucharest
Romania	Dragos Median	Bucharest
Romania	Mircea Dediu	Bucharest
Romania	Rodica Tudor	Bucharest
Romania	Alexandru Eniu	Cluj
Romania	Gabriela Morar Bolba	Cluj
Romania	Bena Sandra	Craiova
Romania	Nelly Cherciu	Craiova
Romania	Diana Petroiu	Iasi
Romania	Simona Angelescu	Targoviste
Romania	Cristina Oprean	Timisoara
Romania	Stefan Curescu	Timisoara
Romania	Cristina Elen Pirau	Vaslui

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		At 12 and 18 months after diagnosis	No
Secondary	The progression free survival (PFS) rates		At 12 and 18 months after diagnosis	No
Secondary	The progression free survival (PFS) time		At 18 months after diagnosis	No
Secondary	Time to progression (TTP)		At 18 months after diagnosis	No
Secondary	The clinical and pathological characteristics of newly diagnosed MBC patients		At 18 months after diagnosis	No
Secondary	The socio-demographic and anthropometric characteristics of newly diagnosed MBC patients		At 18 months after diagnosis	No
Secondary	Health care utilization associated with the disease in Romania		At 18 months after diagnosis	No