A Study on the Epidemiology and Testing of Human Epidermal Growth Factor-Receptor 2 (HER2) in Breast Cancer in Germany

Study Overview
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Brief Summary
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This non-interventional study will collect data from routine diagnostics on HER2 testing of breast cancer in Germany.

Official Title
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A Non-interventional Study on the Epidemiology and Testing of HER2 in Breast Cancer in Germany

Conditions
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Breast Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Samples derived from men and women of age greater than or equal to (>/=) 18 years Samples derived from participants with any stage of histologically confirmed invasive breast cancer with HER2 diagnostics performed within routine (histo-)pathological workup or (Histo-)Pathological work-up of the tumor sample as at or after start of this study Available information on the year of birth of the participant No pre-selection of tumor samples is allowed. Tumor samples have to be documented consecutively in the order of their (histo-)pathological work-up. Exclusion Criteria: Sample derived from participants with any stage of breast cancer with no HER2 diagnostics performed at the time of routine (histo-)pathological work-up. Samples derived prior to the start of this study.

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 |
| --- | --- |
| Breast Cancer Pathology Samples<br>Data on the epidemiology and HER2 testing of breast cancer will be collected from pathology routine diagnostics. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of HER2 Positive Samples |  | 1 day (this is a single time point study) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of HER2 Positive Samples by Carcinoma Subtype (No Special Type\Ductal, Lobular, Other Special Type) |  | 1 day (this is a single time point study) | 
| Number of HER2 Positive Samples by Sample Extraction (Biopsy versus Resectate) |  | 1 day (this is a single time point study) | 
| Number of HER2 Positive Samples by Tumor-Node-Metastasis (TNM) Classification |  | 1 day (this is a single time point study) | 
| Number of HER2 Positive Samples by Sample Source (Primary Tumor, Local Lymph Nodes, Metastasis) |  | 1 day (this is a single time point study) | 
| Number of HER2 Positive Samples by Applied Method of Tissue Fixation |  | 1 day (this is a single time point study) | 
| Number of HER2 Positive Samples by Testing Platform |  | 1 day (this is a single time point study) | 
| Number of HER2 Positive Samples by Automation of Testing |  | 1 day (this is a single time point study) | 
| Number of HER2 Positive Samples by Antibody Clone Antibody or Test Certification |  | 1 day (this is a single time point study) | 
| Number of HER2 Positive Samples by Scoring Algorithm |  | 1 day (this is a single time point study) | 
| Number of HER2 Positive Samples by Round Robin Tests |  | 1 day (this is a single time point study) | 
| Number of HER2 Positive Samples by Institute's Accreditation |  | 1 day (this is a single time point study) | 
| Number of HER2 Positive Samples by Institute's Certification |  | 1 day (this is a single time point study) | 
| Number of HER2 Positive Samples by Tumor Grading |  | 1 day (this is a single time point study) | 
| Number of HER2 Positive Samples by Participant Age |  | 1 day (this is a single time point study) | 
| Number of HER2 Positive Samples by Hormone Receptor Status |  | 1 day (this is a single time point study) |