Study of Human Epidermal Growth Factor Receptor 2 (HER2) Expression in Participants With Early/Metastatic Breast Cancer in Saudi Arabia

Study Overview
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Brief Summary
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This is a retrospective, multicenter study, consisting of chart review of Saudi Arabian participants diagnosed with breast cancer between 2007 and 2013 and with available human epidermal growth factor receptor 2 (HER2) testing. Data on survival will be collected through 2015.

Official Title
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A Retrospective, Observational Molecular Epidemiology Study of HER2 Expression in Patients With Early / Metastatic Breast Cancer in Saudi Arabia

Conditions
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Breast Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Initially diagnosed with breast cancer Has a proven result of HER2 testing by immunohistochemistry (IHC), fluorescent in situ hybridization (FISH) or any other in situ hybridization (ISH) method Alive or not alive Exclusion Criteria: - Inconclusive, equivocal or unavailable result of HER2/neu overexpression by IHC and FISH

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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 |
| --- | --- |
| Participants With Breast Cancer<br>This study will retrospectively collect data from participants with breast cancer in Saudi Arabia. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Positive HER2 Test Result |  | From January 2007 to December 2013 (Up to 7 years; assessed retrospectively) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Estrogen Receptor/Progesterone Receptor Positive Breast Cancer |  | From January 2007 to December 2013 (Up to 7 years; assessed retrospectively) | 
| Percentage of Participants by Type of First-line and Subsequent Treatment Regimens Used |  | From January 2007 to December 2013 (Up to 7 years; assessed retrospectively) | 
| Kaplan-Meier Estimate of Overall Survival (OS) |  | From January 2007 to December 2015 (Up to 9 years; assessed retrospectively) | 
| Kaplan-Meier Estimates of Progression-free Survival (PFS) as Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) |  | From January 2007 to December 2013 (Up to 7 years; assessed retrospectively) | 
| Percentage of Participants With Complete Response as Assessed Using RECIST |  | From January 2007 to December 2013 (Up to 7 years; assessed retrospectively) | 
| Percentage of Participants With Partial Response as Assessed Using RECIST |  | From January 2007 to December 2013 (Up to 7 years; assessed retrospectively) | 
| Percentage of Participants With Progressive Disease as Assessed Using RECIST |  | From January 2007 to December 2013 (Up to 7 years; assessed retrospectively) | 
| Percentage of Participants with Stable Disease as Assessed Using RECIST |  | From January 2007 to December 2013 (Up to 7 years; assessed retrospectively) | 
| Percentage of Participants With Adverse Events |  | From January 2007 to December 2013 (Up to 7 years; assessed retrospectively) |