Breast Cancer
Conditions
Brief summary
This non-interventional study will collect data from routine diagnostics on HER2 testing of breast cancer in Germany.
Interventions
None listed
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of HER2 Positive Samples | 1 day (this is a single time point study) |
Secondary
| Measure | Time frame |
|---|---|
| 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 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 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) |
| Number of HER2 Positive Samples by Scoring Algorithm | 1 day (this is a single time point study) |
Countries
Germany
Outcome results
None listed