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

Completed

• Conditions: Breast Cancer

• Registration Number: NCT02666261
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-11
• Study First Submitted QC: 2016-01-25
• Study First Posted: 2016-01-28
• Study Start: 2016-03-04
• Primary Completion: 2018-02-28
• Study Completion: 2018-02-28
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-19
• Last Update Posted: 2019-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of HER2 Positive Samples	1 day (this is a single time point study)

Secondary Outcome Measures

Name	Time	Method
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 Round Robin Tests	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 Sample Extraction (Biopsy versus Resectate)	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 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 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 Tumor-Node-Metastasis (TNM) Classification	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 Antibody Clone Antibody or Test Certification	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 Institute's Accreditation	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)

Trial Locations

Locations (64)

Klinikum Augsburg; Institut für Pathologie; 🇩🇪 Augsburg, Germany

Sozialstiftung Bamberg; Institut für Pathologie; 🇩🇪 Bamberg, Germany

Klinikum Bayreuth; 🇩🇪 Bayreuth, Germany

Institut für Pathologie, Zytologie & Molekularpathologie in Bergisch Gladbach; 🇩🇪 Bergisch Gladbach, Germany

Gemeinschaftspraxis; Institut für Pathologie am Evangelischen Waldkrankenhaus; 🇩🇪 Berlin - Spandau, Germany

Gemeinschaftspraxis für Pathologie Stefan Berger, Jörg Linke und Ellen Fietze; 🇩🇪 Berlin, Germany

Vivantes Klinikum Neukölln; Fachbereich Pathologie; 🇩🇪 Berlin, Germany

HELIOS Klinikum Emil von Behring Klinik f.Pneumologie Onkologie u.Infektiologie; 🇩🇪 Berlin, Germany

Praxis am St. Agnes-Hospital Bocholt; 🇩🇪 Bocholt, Germany

Institut für Pathologie und Zytologie an der Augusta-Kranken-Anstalt; 🇩🇪 Bochum, Germany

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