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Epidemiology and Management of Metastatic Breast Cancer

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

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 ]

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

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)
Female patients diagosed with metastatic breast cancer

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01711502

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, Romania
Sponsors and Collaborators
Principal Investigator: Dediu Mrcea, SENIOR PHYSICIAN Bucharest Institute of Oncology
Principal Investigator: Alexandru Eniu, SENIOR PHYSICIAN Cluj Institute of Oncology
  More Information

Responsible Party: AstraZeneca 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

Keywords provided by AstraZeneca:
metastatic breast cancer,
retrospective cohort

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases processed this record on May 25, 2017