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AzTrials

Breast CancerNCT02666261

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

An observational study of Breast Cancer, run by Hoffmann-La Roche at 64 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
How many people
15,000 participants
Where
64 sitesGermany
Study dates
4 Mar 2016to 28 Feb 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Breast cancer tissue samples from participants in Germany

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

64 sites in 1 country.

64 sites in 1 country

Germany64 sites

  • Klinikum Augsburg; Institut für Pathologie

    Augsburg, 86156

  • Sozialstiftung Bamberg; Institut für Pathologie

    Bamberg, 96049

  • Klinikum Bayreuth

    Bayreuth, 95445

  • Institut für Pathologie, Zytologie & Molekularpathologie in Bergisch Gladbach

    Bergisch Gladbach, 51465

  • Gemeinschaftspraxis für Pathologie Stefan Berger, Jörg Linke und Ellen Fietze

    Berlin, 10115

  • Vivantes Klinikum Neukölln; Fachbereich Pathologie

    Berlin, 12351

  • HELIOS Klinikum Emil von Behring Klinik f.Pneumologie Onkologie u.Infektiologie

    Berlin, 14165

  • Gemeinschaftspraxis; Institut für Pathologie am Evangelischen Waldkrankenhaus

    Berlin - Spandau, 13589

  • Praxis am St. Agnes-Hospital Bocholt

    Bocholt, 46397

  • Institut für Pathologie und Zytologie an der Augusta-Kranken-Anstalt

    Bochum, 44791

  • Universitätsklinikum Bonn; Zentrum für Pathologie Pathologisches Institut

    Bonn, 53127

  • Klinikum Coburg GmbH - Institut für Pathologie

    Coburg, 96450

  • Institut f. Pathologie, der Univers. Köln

    Cologne, 50937

  • Kliniken der Stadt Köln gGmbH Krankenhaus Merheim

    Cologne, 51109

  • Städtisches Klinikum Dessau; Institut für Pathologie

    Dessau, 06847

  • Gemeinschaftspraxis für Pathologie Dr. Dykgers, Dr. Langwieder, Dr. Rees

    Dortmund, 44137

  • Städtisches Klinikum Dresden; Institut für Pathologie "Georg Schmorl" (Friedrichstadt)

    Dresden, 01067

  • Evangelisches Krankenhaus BETHESDA zu Duisburg GmbH; Institut für Pathologie

    Duisburg, 47053

  • Krankenhaus Düren gem. GmbH; Institut und Praxisgemeinschaft für Pathologie

    Düren, 52351

  • Universitätsklinikum Erlangen; Pathologisches Institut

    Erlangen, 91054

  • OptiPath Gemeinschaftspraxis für Pathologie

    Frankfurt, 60487

  • Universitätsklinikum Freiburg Institut f.Pathologie

    Freiburg im Breisgau, 79106

  • Pathologische Institut Friedrichshafen/Bodensee (Gemeinschaftspraxis für Pathologie und Zytologie)

    Friedrichshafen, 88048

  • Klinik am Eichert; Institut für Pathologie

    Göppingen, 73035

  • Universitätsklinikum Göttingen, Institut für Pathologie

    Göttingen, 37075

  • Institut für Pathologie, MVZ am Lukaskrankenhaus

    Grevenbroich, 41515

  • Klinikum Oberberg; Pathologisches Institut Kreiskrankenhaus Gummersbach

    Gummersbach, 51643

  • Pathologisches Institut am Allg. KH Stadt Hagen; Stambolis, Wolf von Rhüden, Ruwe

    Hagen, 58095

  • Universitätsklinikum Halle (Saale), Institut für Pathologie

    Halle, 06112

  • Kath. Marienkrankenhaus gGmbH

    Hamburg, 22087

  • Fachärzte Dres Tiemann & Schulte Partnerschaft; Institut für Hämatopathologie Hamburg

    Hamburg, 22547

  • Gemeinschaftspraxis für Pathologie Hamm, Dres. Diebold/Niemann

    Hamm, 59071

  • Gemeinschaftspraxis Dr. Hartmut Fitz, Dr. Sebastian Blasius und PD Dr. Christian August

    Hanau, 63450

  • Dres. Wolfgang Beschow Eckehardt Kupsch Herbert Radner u.w.

    Hanover, 30175

  • Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe

    Hanover, 30625

  • Pathologisches Institut

    Heidelberg, 69120

  • Institut für Pathologie Hildesheim

    Hildesheim, 31135

  • Gemeinschaftspraxis für Pathologie Ingolstadt Dr. König, Dr. Popp, Prof. Dr. Adam

    Ingolstadt, 85049

  • Universitätsklinikum Jena; Institut für Pathologie

    Jena, 07743

  • Städtisches Klinikum Karlsruhe gGmbH; Pathologisches Institut

    Karlsruhe, 76113

  • Institut Für Pathologie Nordhessen

    Kassel, 34119

  • Institut für Pathologie Kassel

    Kassel, 34125

  • Institut für Pathologie, Universitäsklinikum Schleswig-Holstein

    Kiel, 24105

  • Klinikum Konstanz gGmbH, Institut und Praxis für Pathologie

    Konstanz, 78464

  • Gemeinschaftspraxis für Pathologie Lübeck; Turzynski, Lebeau, Gocht, Leuenroth

    Lübeck, 23552

  • Universitätsklinikum Magdeburg; Institut für Pathologie und Neuropathologie

    Magdeburg, 39120

  • Klinikum Magdeburg GmbH

    Magdeburg, 39130

  • Klinikum Mannheim; Pathologisches Institut

    Mannheim, 68167

  • Institut für Pathologie

    Mühlhausen, 99974

  • Pathologie München-Nord

    München, 80992

  • Institut für Pathologie der Universität Münster, Albert Schweitzer Campus, Gebäude D17

    Münster, 48149

  • Institut für Pathologie am Clemenshospital Münster

    Münster, 48153

  • Dietrich Bonhoeffer Kliniken Neubrandenburg, Institut für Pathologie

    Neubrandenburg, 17022

  • Zentrum für Pathologie, Zytologie und Molekularpathologie Neuss

    Neuss, 41462

  • Evangelisches Krankenhaus Oberhausen GmbH, Institut f.Pathologie

    Oberhausen, 46047

  • Pathocom - Gemeinschaftspraxis Bischofsstraße Osnabrück

    Osnabrück, 49074

  • Pathologisches Institut Recklinghausen

    Recklinghausen, 45659

  • Klinikum am Steinenberg / Ermstalklinik

    Reutlingen, 72764

  • Diakoniekrankenhaus Institut f.Pathologie

    Rotenburg (Wümme), 27356

  • Leopoldina Krankenhaus der Stadt Schweinfurt GmbH; Pathologie

    Schweinfurt, 97422

  • HELIOS Klinikum Schwerin; Frauenklinik

    Schwerin, 19049

  • Gemeinschaftspraxis PD Dr.med. Meinald Schultz und Dr.med. Petra Lüders

    Stendal, 39576

  • Robert-Bosch-Krankenhaus; Pathologisches Institut

    Stuttgart, 70376

  • Gemeinschaftspraxis für Pathologie Weiden; am Klinikum Weiden; Giedl, Stelter und Meier

    Weiden, 92637

Other trials in Germany

About this study

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

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

Conditions
Breast Cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02666261
Study groupRoleWhat they receive
Breast Cancer Pathology SamplesData on the epidemiology and HER2 testing of breast cancer will be collected from pathology routine diagnostics.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of HER2 Positive Samples

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

Secondary outcomes (15)

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

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

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

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

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

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

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

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

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

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

  6. Number of HER2 Positive Samples by Testing Platform

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

  7. Number of HER2 Positive Samples by Automation of Testing

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

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

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

  9. Number of HER2 Positive Samples by Scoring Algorithm

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

  10. Number of HER2 Positive Samples by Round Robin Tests

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

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

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

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

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

  13. Number of HER2 Positive Samples by Tumor Grading

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

  14. Number of HER2 Positive Samples by Participant Age

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

  15. Number of HER2 Positive Samples by Hormone Receptor Status

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2016 (estimated)
  2. Study start4 Mar 2016
  3. Primary completion28 Feb 2018
  4. Study completion28 Feb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
15,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02666261
Sponsor's protocol ID
ML29763
Status last verified
Mar 2019
First submitted
11 Jan 2016
Last updated
21 Mar 2019
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer, run by Hoffmann-La Roche at 64 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of HER2 Positive Samples (time frame: 1 day (this is a single time point study)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02666261.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2019.

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