Brain Metastasis in Breast Cancer Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Cancer

Intervention / Treatment
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* Drug: Trastuzumab or Lapatinib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women diagnosed with advanced breast cancer<br>Women diagnosed with advanced breast cancer during January 1, 1995-December 31, 2007 and treated as part of the Henry Ford Health System | Drug: Trastuzumab or Lapatinib<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Treatment, Brain metastases, ErbB2 expression