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

N/ACompletedNCT02666261

Hoffmann-La Roche15,000 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

15,000

Conditions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (64)

Outcomes

Primary Outcomes

Number of HER2 Positive Samples

Time frame: 1 day (this is a single time point study)

Secondary Outcomes

Number of HER2 Positive Samples by Carcinoma Subtype (No Special Type\Ductal, Lobular, Other Special Type)

Time frame: 1 day (this is a single time point study)

Number of HER2 Positive Samples by Sample Extraction (Biopsy versus Resectate)

Time frame: 1 day (this is a single time point study)

Number of HER2 Positive Samples by Tumor-Node-Metastasis (TNM) Classification

Time frame: 1 day (this is a single time point study)

Number of HER2 Positive Samples by Sample Source (Primary Tumor, Local Lymph Nodes, Metastasis)

Time frame: 1 day (this is a single time point study)

Number of HER2 Positive Samples by Applied Method of Tissue Fixation

Time frame: 1 day (this is a single time point study)

Number of HER2 Positive Samples by Testing Platform

Time frame: 1 day (this is a single time point study)

Number of HER2 Positive Samples by Automation of Testing

Time frame: 1 day (this is a single time point study)

Number of HER2 Positive Samples by Antibody Clone Antibody or Test Certification

Time frame: 1 day (this is a single time point study)

Number of HER2 Positive Samples by Scoring Algorithm

Data from ClinicalTrials.gov

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