Epidemiology and Management of Metastatic Breast Cancer

Completed

• Conditions: Breast Cancer Nos Metastatic Recurrent

• Registration Number: NCT01711502
• Lead Sponsor: AstraZeneca

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

Study Timeline

• Study First Submitted: 2012-10-18
• Study First Submitted QC: 2012-10-18
• Study First Posted: 2012-10-22
• Study Start: 2013-01
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-29
• Last Update Posted: 2014-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 128

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (15)

Stefan Curescu; 🇷🇴 Timisoara, Romania

Doina Coste Gherasim; 🇷🇴 Baia Mare, Romania

Mircea Dediu; 🇷🇴 Bucharest, Romania

Gabriela Morar Bolba; 🇷🇴 Cluj, Romania

Bena Sandra; 🇷🇴 Craiova, Romania

Diana Petroiu; 🇷🇴 Iasi, Romania

Cristina Oprean; 🇷🇴 Timisoara, Romania

Cristina Elen Pirau; 🇷🇴 Vaslui, Romania

Daniel Ciurescu; 🇷🇴 Brasov, Romania

Nelly Cherciu; 🇷🇴 Craiova, Romania

Dana Lucia Stanculeanu; 🇷🇴 Bucharest, Romania

Dragos Median; 🇷🇴 Bucharest, Romania

Rodica Tudor; 🇷🇴 Bucharest, Romania

Alexandru Eniu; 🇷🇴 Cluj, Romania

Simona Angelescu; 🇷🇴 Targoviste, Romania