Epidemiology and Management of Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01711502
First received: October 18, 2012
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

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.


Condition
Breast Cancer Nos Metastatic Recurrent

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Epidemiology and Therapeutic Management of Metastatic Breast Cancer in Romania: A Retrospective Cohort Study

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The progression free survival (PFS) rates [ Time Frame: At 12 and 18 months after diagnosis ] [ Designated as safety issue: No ]
  • The progression free survival (PFS) time [ Time Frame: At 18 months after diagnosis ] [ Designated as safety issue: No ]
  • Time to progression (TTP) [ Time Frame: At 18 months after diagnosis ] [ Designated as safety issue: No ]
  • The clinical and pathological characteristics of newly diagnosed MBC patients [ Time Frame: At 18 months after diagnosis ] [ Designated as safety issue: No ]
  • The socio-demographic and anthropometric characteristics of newly diagnosed MBC patients [ Time Frame: At 18 months after diagnosis ] [ Designated as safety issue: No ]
  • Health care utilization associated with the disease in Romania [ Time Frame: At 18 months after diagnosis ] [ Designated as safety issue: No ]

Enrollment: 128
Study Start Date: January 2013
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Female patients diagosed with metastatic breast cancer

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01711502

Locations
Romania
Doina Coste Gherasim
Baia Mare, Romania
Daniel Ciurescu
Brasov, Romania
Mircea Dediu
Bucharest, Romania
Dragos Median
Bucharest, Romania
Dana Lucia Stanculeanu
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
Stefan Curescu
Timisoara, Romania
Cristina Oprean
Timisoara, Romania
Cristina Elen Pirau
Vaslui, Romania
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Dediu Mrcea, SENIOR PHYSICIAN Bucharest Institute of Oncology
Principal Investigator: Alexandru Eniu, SENIOR PHYSICIAN Cluj Institute of Oncology
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01711502     History of Changes
Other Study ID Numbers: NIS-ORO-XXX-2012/1
Study First Received: October 18, 2012
Last Updated: January 29, 2014
Health Authority: Romania: National Agency for Medicines and Medical Devices
Romania: Ethics Committee

Keywords provided by AstraZeneca:
metastatic breast cancer,
epidemiology,
retrospective cohort

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 15, 2014