Management of Metastatic Breast Cancer in Clinical Practice - Retrospective Study

August 21, 2013 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

171

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Pleven, Bulgaria
        • Research Site
      • Plovdiv, Bulgaria
        • Research Site
      • Ruse, Bulgaria
        • Research Site
      • Sofia, Bulgaria
        • Research Site
      • Stara Zagora, Bulgaria
        • Research Site
      • Varna, Bulgaria
        • Reaseach Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of progression events on a per patient-year-basis
Time Frame: Up to 2 years 5 months
Up to 2 years 5 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Up to 2 years 5 months
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
Up to 2 years 5 months
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
Up to 2 years 5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

October 22, 2012

First Submitted That Met QC Criteria

October 24, 2012

First Posted (Estimate)

October 26, 2012

Study Record Updates

Last Update Posted (Estimate)

August 22, 2013

Last Update Submitted That Met QC Criteria

August 21, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-OBG-XXX-2012/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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