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Management of Metastatic Breast Cancer in Clinical Practice - Retrospective Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01715155
First received: October 22, 2012
Last updated: April 29, 2013
Last verified: April 2013
History of Changes
  Purpose

The purpose of this study is to evaluate the incidence rate of progression of disease, to describe the diagnostic and clinical management in patients with Metastatic Breast Cancer in the clinical practice in Bulgaria.


Condition
Metastatic Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Cohort Study on Therapeutic Management of Metastatic Breast Cancer in Clinical Practice in Bulgaria

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Number of progression events on a per patient-year-basis [ Time Frame: Up to 2 years 5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients among study population who have not progressed at 12 and 18 months after they were diagnosed [ Time Frame: Up to 2 years 5 months ] [ Designated as safety issue: No ]
  • Median and mean time interval that elapsed between diagnosis and first objective tumor progression (TTP) event and subsequent events [ Time Frame: Up to 2 years 5 months ] [ Designated as safety issue: No ]
  • Median and mean time from the date of diagnosis to the date of breast cancer progression or death whichever occurred first [ Time Frame: Up to 2 years 5 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: December 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Female patients diagnosed with metastatic breast cancer
Patients newly diagnosed with metastatic breast cancer, either De Novo or having progressed from a non-metastatic stage.

Detailed Description:

A Retrospective Cohort Study on Therapeutic Management of Metastatic Breast Cancer in Clinical Practice in Bulgaria

  Eligibility

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

Patients newly diagnosed with breast cancer (according to ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage.

Criteria

Inclusion Criteria:

  • New diagnosis of breast cancer according to ICD-10 with confirmed metastasis
  • Confirmed diagnosis between 1st October 2010 and 31st March 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: NCT01715155

Locations
Bulgaria
Research Site
Pleven, Bulgaria
Research Site
Plovdiv, Bulgaria
Research Site
Ruse, Bulgaria
Research Site
Sofia, Bulgaria
Research Site
Stara Zagora, Bulgaria
Reaseach Site
Varna, Bulgaria
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01715155     History of Changes
Other Study ID Numbers: NIS-OBG-XXX-2012/1
Study First Received: October 22, 2012
Last Updated: April 29, 2013
Health Authority: Bulgaria: Bulgarian Drug Agency

Keywords provided by AstraZeneca:
Metastatic Breast Cancer,
retrospective study,
disease progression,
clinical management

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

ClinicalTrials.gov processed this record on June 13, 2013