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NCT Number: NCT02666261

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

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Augsburg; Institut für Pathologie, Augsburg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number of HER2 Positive Samples

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

Secondary outcomes

  1. 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)

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

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

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

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

  4. 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)

  5. Number of HER2 Positive Samples by Applied Method of Tissue Fixation

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

  6. Number of HER2 Positive Samples by Testing Platform

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

  7. Number of HER2 Positive Samples by Automation of Testing

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

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

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

  9. Number of HER2 Positive Samples by Scoring Algorithm

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

  10. Number of HER2 Positive Samples by Round Robin Tests

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

  11. Number of HER2 Positive Samples by Institute's Accreditation

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

  12. Number of HER2 Positive Samples by Institute's Certification

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

  13. Number of HER2 Positive Samples by Tumor Grading

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

  14. Number of HER2 Positive Samples by Participant Age

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

  15. Number of HER2 Positive Samples by Hormone Receptor Status

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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 28, 2016
Registry last updated
Mar 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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