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Gene test may spare thousands from chemo

NCT ID NCT03503799

Knowledge-focused Sponsor: North Eastern German Society of Gynaecological Oncology Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows over 1,100 women with early-stage, hormone-sensitive breast cancer who took the EndoPredict® gene test. Researchers want to see if those classified as 'low risk' can safely receive only hormone therapy without chemotherapy. The goal is to confirm that 10-year survival without distant cancer spread exceeds 90% in this group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could confirm that many women with early-stage breast cancer can safely avoid chemotherapy based on a gene test.
What could go wrong
This is an observational study, not a treatment trial. Results will take years, and the test may not work as well for all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

1,191 people

The number who actually took part.

Started

Jul 2018

Expected to finish

Oct 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with primary stage I or Ii breast cancer who met all inclusin and no exclusion criteria

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Informed consent 2. Tested with EndoPredict within the previous 6 months before inclusion 3. Age ≥ 18 years 4. Patients with primary invasive breast cancer, Stage I/II 5. ER-positive 6. HER2-negative 7. N0 or N1 (1-3 positive lymph nodes) 8. T1 - T3 Exclusion Criteria: 1. Inflammatory breast cancer 2. Bilateral breast cancer 3. Breast cancer in the last 10 years 4. Other invasive malignancies in the last 5 years

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Conditions

The condition(s) this trial relates to.

breast neoplasm estrogen-receptor positive breast cancer invasive breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Estrogen receptor positive tumor Human epidermal growth factor receptor 2 negative tumor Primary invasive breast cancer

Contacts and locations

Locations

  • ANregiomed Ansbach

    Ansbach, 91522, Germany

  • Asklepios Klinik Barmbek

    Hamburg, 22307, Germany

  • Brustzentrum Bern Lindenhofgruppe

    Bern, 3012, Switzerland

  • Charité - Universitätsmedizin Berlin

    Mitte, 10117, Germany

  • DRK Kliniken Köpenick

    Berlin, 12559, Germany

  • Ernst von Bergmann Klinikum

    Potsdam, 14467, Germany

  • Evangelisches Krankenhaus

    Düsseldorf, 40217, Germany

  • Frauenklinik der Technischen Universität München

    München, Bavaria, 81675, Germany

  • Frauenärzte am Bahnhofsplatz

    Hildesheim, 31134, Germany

  • Gemeinschaftsklinikum Mittelrhein gGmbH Kemperhof

    Koblenz, 56073, Germany

  • Gemeinschaftspraxis Gynäkologie Arabella

    München, 81925, Germany

  • Harzklinikum Dorothea Christiane Erxleben

    Wernigerode, 38855, Germany

  • Helios Klinikum Berlin Buch

    Berlin, 13125, Germany

  • Helios Universitätsklinikum Wuppertal

    Wuppertal, 42283, Germany

  • Klinikum Bremerhaven Reinkenheide

    Bremerhaven, 27574, Germany

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09116, Germany

  • Klinikum Erding

    Erding, 85435, Germany

  • Klinikum Fichtelgebirge

    Marktredwitz, 95615, Germany

  • Klinikum Magdeburg gGmbH

    Magdeburg, 39130, Germany

  • Klinikum Mutterhaus der Borromäerinnen gGmbH

    Trier, 54290, Germany

  • Klinikum Traunstein

    Traunstein, 83278, Germany

  • Krankenhaus Jerusalem

    Hamburg, 20357, Germany

  • Krankenhaus St. Elisabeth und St. Barbara

    Halle, Germany

  • Krankenhaus St. Joseph Stift Dresden GmbH

    Dresden, 01307, Germany

  • Krankenhaus St. Marienstift

    Magdeburg, 39110, Germany

  • Kreisklinik Ebersberg

    Ebersberg, 85560, Germany

  • Luzerner Kantonsspital

    Lucerne, 6000, Switzerland

  • MVZ Hellersdorf - Zweigstelle Biesdorf

    Berlin, 12683, Germany

  • Mathilden Hospital

    Herford, 32052, Germany

  • Oberhavel Kliniken GmbH

    Oranienburg, 16515, Germany

  • Park-Klinik Weißensee

    Berlin, 13086, Germany

  • Praxis Dr. Heinrich

    Fürstenwalde, 15517, Germany

  • Regioklinik Pinneberg

    Pinneberg, 25421, Germany

  • RoMed Klinikum Rosenheim

    Rosenheim, 83022, Germany

  • Spital Zollikerberg

    Zurich, Switzerland

  • Universitätsklinikum Carl Gustav Carus

    Dresden, 01307, Germany

  • Universitätsklinikum Jena

    Jena, 07747, Germany

  • Universitätsklinikum Regensburg

    Regensburg, 93053, Germany

  • VK & K Studien GbR

    Landshut, 84036, Germany

  • Vivantes Klinikum am Urban

    Berlin, State of Berlin, 10967, Germany

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