Epidemiology and Management of Metastatic Breast Cancer

January 29, 2014 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

128

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Female patients diagosed with metastatic breast cance, age > 18 years

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Female patients diagosed with metastatic breast cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
At 12 and 18 months after diagnosis

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Dediu Mrcea, SENIOR PHYSICIAN, Bucharest Institute of Oncology
  • Principal Investigator: Alexandru Eniu, SENIOR PHYSICIAN, Cluj Institute of Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

October 18, 2012

First Submitted That Met QC Criteria

October 18, 2012

First Posted (ESTIMATE)

October 22, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 30, 2014

Last Update Submitted That Met QC Criteria

January 29, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-ORO-XXX-2012/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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