Brain Metastasis in Breast Cancer Patients

Cancer Clinical Trial

Official title: Occurrence of Brain Metastasis in Breast Cancer Patients Diagnosed at Advanced Stages of the Disease

Status Completed

Clinical Trial Summary

The purpose of this epidemiologic study is to establish a population-based cohort of women with advanced stage breast cancer which can be used to quantify the frequency and timing of brain metastases, and other distant metastases, in this patient population.

Clinical Trial Description

A retrospective cohort study will be conducted in the Henry Ford Health System (HFHS). Using medical record review, we will identify all women diagnosed with advanced stage (stage III and IV) breast cancer between January 1, 1995- December 31, 2007. For each case included in the study, we will obtain data on demographics, tumor information, treatment related medical encounters and procedures, and occurrence and timing of brain and/or other distant metastases. The main outcome for this study is the development of distant metastases. Each patient in the cohort will be classified as to the occurrence and date of distant metastases. Metastases will be classified as Brain, Distant lymph node, Lung/pleural effusion, Liver, Bone, Other visceral, Other non-visceral.

Other secondary outcomes to be explored include:

• Survival after advanced breast cancer—time in months from the date of advanced stage breast cancer diagnosis until death or end of study period

• Time to brain metastases—time in month from the date of advanced stage breast cancer diagnosis until brain metastases diagnosis

• Survival after brain metastases—time in months from the date of diagnosis of brain metastases until death or end of study period ;

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cancer

• NCT number: NCT01077648
• Study type: Observational
• Source: GlaxoSmithKline
• Status: Completed
• Phase: N/A
• Start date: February 2010
• Completion date: August 2013