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

October 18, 2012
January 29, 2014
January 2013
June 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01711502 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Epidemiology and Management of Metastatic Breast Cancer
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.

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

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

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

Breast Cancer Nos Metastatic Recurrent
Not Provided
Female patients diagosed with metastatic breast cancer
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
128
June 2013
June 2013   (final data collection date for primary outcome measure)

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)
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Romania
 
NCT01711502
NIS-ORO-XXX-2012/1
No
AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Dediu Mrcea, SENIOR PHYSICIAN Bucharest Institute of Oncology
Principal Investigator: Alexandru Eniu, SENIOR PHYSICIAN Cluj Institute of Oncology
AstraZeneca
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP