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Completed

NCT Number: NCT01715155

Management of Metastatic Breast Cancer in Clinical Practice - Retrospective Study

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Research Site, Pleven, Bulgaria

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • New diagnosis of breast cancer according to ICD-10 with confirmed metastasis
  • Confirmed diagnosis between 1st July 2010 and 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).

Treatment and study plan

Primary outcomes

  1. Number of progression events on a per patient-year-basis

    Time frame: Up to 2 years 5 months

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 26, 2012
Registry last updated
Aug 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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