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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01077648
• Other study ID #: 112951
• Status: Completed
• Phase: N/A
• First received: February 25, 2010
• Last updated: May 22, 2014
• Start date: February 2010
• Est. completion date: August 2013

Study information

• Verified date: May 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: GSK Observational Study
• Study type: Observational

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• Initially diagnosed with American Joint Commission on Cancer (AJCC) stage III or stage IV breast cancer between January 1, 1995 through December 31, 2007 -OR- diagnosed with AJCC stage I or II breast cancer and progressed to stage III or IV disease between January 1, 1995 through December 31, 2007;

• At least one year of follow-up after initial diagnosis (among patients who did not die before one year of follow-up); and

• Age 30 years or older at diagnosis.

Exclusion Criteria:

• Does not have at least one year of follow-up after initial diagnosis (among patients who did not die before one year of follow-up); and

• Age less than 30 years or older at diagnosis.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• Trastuzumab or Lapatinib
Anti-erbB2 therapy for breast cancer treatment will be analyzed as a class level variable; individual drugs including trastuzumab and lapatinib will also be explored as exposures if sufficient numbers of patients exist.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of advanced stage breast cancer patients that develop brain metastases, overall and stratified by anti-HER2 therapy (for HER2+ patients only).		Time from breast cancer diagnosis until death or end of study periods (September 1, 2009)	No
Secondary	Overall survival from advanced stage breast cancer, overall and stratified by tumor characteristics and anti-HER2 therapy (for HER2+ patients only).		Time from diagnosis of advanced stage breast cancer until death or end of study period (September 1, 2009)	No
Secondary	Time to brain metastases stratified by key tumor characteristics and anti-HER2 therapy (for HER2+ patients only).		Time from diagnosis of advanced stage breast cancer until brain metastases diagnosis	No
Secondary	Survival after brain metastases diagnosis, overall and stratified by key tumor characteristics and anti-HER2 therapy (for HER2+ patients only)		Time from diagnosis of brain metastases until death or end of study period (September 1, 2009)	No