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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women diagnosed with advanced breast cancer | Women diagnosed with advanced breast cancer during January 1, 1995-December 31, 2007 and treated as part of the Henry Ford Health System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trastuzumab or Lapatinib | Drug | 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. |
| 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) |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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This study aims to retrospectively collect data on nearly 4,000 advanced breast cancer cases treated within the Henry Ford Health System
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D001943 | Breast Neoplasms |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000068878 | Trastuzumab |
| D000077341 | Lapatinib |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| 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) |
| D016543 |
| Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |