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New study tracks best breast cancer treatment for younger women

NCT ID NCT05792150

Knowledge-focused Sponsor: Women's Cancer Study Group GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 06, 2026 · Updated 2 times

Summary

This study follows premenopausal women with a common type of early breast cancer to see how well different treatments work over time. Participants either receive hormone therapy (with or without ovarian suppression) or chemotherapy followed by hormone therapy. The goal is to understand which approach leads to better long-term outcomes and quality of life.

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

About 1,470 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2022

Expected to finish

Jun 2035

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

For this registry, it is planned to screen N=3000 pre- and perimenopausal patients with early breast cancer who meet the inclusion criteria, i.e., intermediate to high clinical risk for recurrence, and who will receive or have received a routine genomic testing by MammaPrint® with a low/ultralow genomic risk. It is anticipated that 75% of these patients will be nodal negative and 25% nodal positive.

Ages

18 to 60 years

Sex

Female participants only

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: Patients are eligible for participation in the registry only if they meet all the following criteria: * Female breast cancer patients * Pre- or perimenopausal at registry entry (age \<60 years and state after hysterectomy or amenorrhea for \<12 months; confirmation by blood hormone levels (FSH and estradiol in premenopausal range as per local normal range) recommended) * Primary tumor diagnosis not older than three months prior to inclusion (primary diagnosis defined as date of initial tumor biopsy) * Estrogen- and/or progesterone-receptor-positive/HER2 negative early breast cancer without any clinical signs of metastases * Adequate risk for recurrence: * intermediate clinical risk for recurrence, defined as (clinical in case of neoadjuvant treatment): * c/pT1 and * c/pN0 and * Ki-67 15-24% or * G2 or * patients, who do not meet these criteria but are at intermediate clinical risk for recurrence at investigator decision (e.g., very young age, low expression of hormone receptors, existing co-morbidities, familial cancer burden, etc.) can be included on individual decision basis or * high clinical risk for recurrence, defined as either (clinical in case of neoadjuvant treatment): * c/pT2-4 or * c/pN1 or * Ki-67 ≥25% or * G3 * Low genomic risk of recurrence by MammaPrint® (tested on treatment naïve tumor specimen) * Luminal-type by BluePrint® * Treatment according to standard-of-care (e.g., AGO Guidelines) planned or started (until completion of local therapy the latest (including started or completed endocrine induction therapy), started, or planned adjuvant or neoadjuvant treatment) * Availability of untreated tumor material (core biopsy if preoperative endocrine therapy performed or neoadjuvant treatment intended or surgery specimen) * Capability to give written informed consent * Nodal positive patients will be accepted to the registry up to 25% of the genomic low/ultralow-risk population (n=441). Exclusion Criteria: Patients will not be eligible for the registry for any of the following reasons: * Any other genomic testing, besides MammaPrint®, has been performed on the tumor material * Medical or psychological conditions that would not permit the patient to sign informed consent * Legal incapacity or limited legal capacity * Current participation in any interventional clinical trial which tests anticancer drugs, immunotherapeutics, or antibody treatment for any type of neoplasm * Non-compliance of the patient

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm female breast carcinoma

As listed by the trial registrant

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

Female breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    61 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AGAPLESION Allgemeines Krankenhaus Hagen

    RECRUITING

    Hagen, North Rhine-Westphalia, 58095, Germany

  • AGAPLESION Diakonie Hamburg

    RECRUITING

    Hamburg, Free and Hanseatic City of Hamburg, 20259, Germany

  • Altmark- Klinikum

    RECRUITING

    Hansestadt Salzwedel, Saxony-Anhalt, 29410, Germany

  • Asklepios Klinik Barmbek

    RECRUITING

    Hamburg, Free and Hanseatic City of Hamburg, 22307, Germany

  • Brustzentrum Niederrhein, Johanniter Bethesda Krankenhaus

    RECRUITING

    Mönchengladbach, North Rhine-Westphalia, 41061, Germany

  • Caritas-Krankenhaus St. Josef, Klinik für Frauenheilkunde & Geburtshilfe

    RECRUITING

    Regensburg, Bavaria, 93053, Germany

  • Christliches Klinikum Unna gGmbH

    RECRUITING

    Unna, North Rhine-Westphalia, 59423, Germany

  • DIAKO Ev. Diakonie-Krankenhaus gemeinnützige GmbH

    RECRUITING

    Bremen, Free Hanseatic City of Bremen, 28239, Germany

  • DIAKOVERE Henriettenstift

    RECRUITING

    Hanover, Lower Saxony, 30171, Germany

  • DRK Kliniken Berlin Köpenick

    RECRUITING

    Berlin, State of Berlin, 12559, Germany

  • Diakonieklinikum Stuttgart, Brustzetrum

    ACTIVE_NOT_RECRUITING

    Stuttgart, Baden-Wurttemberg, 70176, Germany

  • Elisabethkrankenhaus Kassel, Brustzentrum

    RECRUITING

    Kassel, Hesse, 34117, Germany

  • Evang. Kliniken Essen Mitte, Interdisziplinäres Brustkrebszentrum

    RECRUITING

    Essen, North Rhine-Westphalia, 45136, Germany

  • Evangelisches Krankenhaus BETHESDA zu Duisburg GmbH, Brustzentrum

    RECRUITING

    Duisburg, North Rhine-Westphalia, 47053, Germany

  • Evangelisches Krankenhaus Wesel GmbH

    RECRUITING

    Wesel, North Rhine-Westphalia, 46485, Germany

  • Frauenklinik St. Louise - St. Vincenz-Krankenhaus GmbH

    RECRUITING

    Paderborn, North Rhine-Westphalia, 33098, Germany

  • GRN Klinik Weinheim/ Gynäkologie/Brustzentrum

    RECRUITING

    Weinheim, Baden-Wurttemberg, 69469, Germany

  • Gemeinschaftskrankenhaus Herdecke gemeinnützige GmbH

    RECRUITING

    Herdecke, North Rhine-Westphalia, 58313, Germany

  • Gemeinschaftskrankenhaus/ Brustzentrum Havelhöhe

    RECRUITING

    Berlin, Brandenburg, 14089, Germany

  • Gesundheitszentrum Wetterau gGmbH Hochwaldkrankenhaus Bad Nauheim

    RECRUITING

    Bad Nauheim, Hesse, 61231, Germany

  • Gynäkologische Praxisklinik Hamburg-Harburg

    RECRUITING

    Hamburg, Free and Hanseatic City of Hamburg, 21073, Germany

  • Gynäkologische- Geburtshilfliche Klinik

    RECRUITING

    Bad Soden am Taunus, Hesse, 65812, Germany

  • Gynäkologisches Zentrum

    ACTIVE_NOT_RECRUITING

    Bonn, North Rhine-Westphalia, 53111, Germany

  • HOP Gemeinschaftspraxis Dres. Heinrich/Bangerter, Augsburg

    RECRUITING

    Augsburg, Bavaria, 86150, Germany

  • Helios Klinikum Krefeld, Zentrum für Ambulante Gynäkologische Onkologie - Studienabteilung

    RECRUITING

    Krefeld, Germany

  • Helios Klinikum Pforzheim, Brustzentrum

    RECRUITING

    Pforzheim, Baden-Wurttemberg, 75175, Germany

  • Helios Klinikum Wuppertal

    RECRUITING

    Wuppertal, North Rhine-Westphalia, 42283, Germany

  • Hämatologie/Onkologie Praxis

    RECRUITING

    Bremen, Free Hanseatic City of Bremen, 28209, Germany

  • Katholisches Klinikum Lünen/Werne

    RECRUITING

    Lünen, North Rhine-Westphalia, 44534, Germany

  • Kliniken der Stadt Köln

    RECRUITING

    Cologne, North Rhine-Westphalia, 51067, Germany

  • Klinikum Bremerhaven Reinkenheide

    RECRUITING

    Bremerhaven, Free Hanseatic City of Bremen, 27574, Germany

  • Klinikum Dortmund gGmbH, Beurhausstr.40

    RECRUITING

    Dortmund, North Rhine-Westphalia, 44137, Germany

  • Klinikum Fürstenfeldbruck, Westdeutsches Brust- Centrum

    RECRUITING

    Fürstenfeldbruck, Bavaria, 82256, Germany

  • Klinikum Hanau GmbH

    ACTIVE_NOT_RECRUITING

    Hanau, Hesse, 63450, Germany

  • Klinikum Leverkusen, Am Gesundheitspark

    RECRUITING

    Leverkusen, North Rhine-Westphalia, 51375, Germany

  • Klinikum Luckenwalde

    RECRUITING

    Luckenwalde, Brandenburg, 14943, Germany

  • Klinikum St. Marien Amberg

    RECRUITING

    Amberg, Bavaria, 9224, Germany

  • Klinikum Südstadt

    RECRUITING

    Rostock, Mecklenburg-Vorpommern, 18059, Germany

  • Klinikum Traunstein, Frauenklinik Südostbayern

    RECRUITING

    Traunstein, Germany

  • Klinikum Worms

    RECRUITING

    Worms, Rhineland-Palatinate, 67550, Germany

  • Klinikum der Universität München

    RECRUITING

    München, Bavaria, 80336, Germany

  • Klinikum-Mittelbaden GmbH, Studienzentrale/Brustzentrum

    RECRUITING

    Baden-Baden, Baden-Wurttemberg, 76532, Germany

  • Krankenhaus St. Elisabeth und St. Barbara Halle/Saale

    RECRUITING

    Halle, Saxony-Anhalt, 06110, Germany

  • Luisenkrankenhaus GmbH Co KG

    RECRUITING

    Düsseldorf, North Rhine-Westphalia, 40235, Germany

  • MKS St. Paulus Schwerte (ehemals Marienkrankenhaus)

    ACTIVE_NOT_RECRUITING

    Schwerte, Germany

  • Marien Hospital Düsseldorf

    RECRUITING

    Düsseldorf, North Rhine-Westphalia, 40479, Germany

  • Marienhospital Aachen

    RECRUITING

    Aachen, North Rhine-Westphalia, 52066, Germany

  • Marienhospital, Klinik für Gynäkologie und Geburtshilfe

    RECRUITING

    Bottrop, Germany

  • Mathias-Spital-Rheine

    RECRUITING

    Rheine, North Rhine-Westphalia, 48431, Germany

  • Med. Zentrum f. Hämatologie und Onkologie München

    ACTIVE_NOT_RECRUITING

    München, Bavaria, 80639, Germany

  • Medias Klinikum

    ACTIVE_NOT_RECRUITING

    Burghausen, Bavaria, 84489, Germany

  • Medionko - Praxisklinik Krebsheilkunde Frauen

    ACTIVE_NOT_RECRUITING

    Berlin, State of Berlin, 10367, Germany

  • Onkologische Praxis Oldenburg, Gemeinschaftspraxis für Innere Medizin, Hämatologie und Onkologie

    RECRUITING

    Oldenburg, Lower Saxony, 26121, Germany

  • Praxisnetzwerk Hämatologie/int. Onkologie

    RECRUITING

    Troisdorf, North Rhine-Westphalia, 53840, Germany

  • St. Antonius Hospital Kleve (Katholisches Kral Leistner Zentrum)

    RECRUITING

    Goch, North Rhine-Westphalia, 47574, Germany

  • St. Barbara Klinik

    RECRUITING

    Hamm, North Rhine-Westphalia, 59073, Germany

  • St. Franziskus-Hospital

    RECRUITING

    Münster, North Rhine-Westphalia, 48145, Germany

  • St. Gertrauden Krankenhaus Brustzentrum City Berlin

    RECRUITING

    Berlin, State of Berlin, 10713, Germany

  • St. Josefs-Hospital Wiesbaden GmbH

    RECRUITING

    Wiesbaden, Hesse, 65189, Germany

  • St. Vincenz-Krankenhaus Datteln

    RECRUITING

    Datteln, North Rhine-Westphalia, 45711, Germany

  • Studienzentrum Onkologie Ravensburg

    RECRUITING

    Ravensburg, Baden-Wüttemberg, 88212, Germany

  • Studienzentrum Untere Ems

    RECRUITING

    Leer, Lower Saxony, 26789, Germany

  • Universitaetsklinikum Muenster

    RECRUITING

    Münster, North Rhine-Westphalia, 48149, Germany

  • Universität Marburg, Klinik für Frauenheilkunde, Brustzentrum

    ACTIVE_NOT_RECRUITING

    Marburg, Hesse, 35043, Germany

  • Universitätsfrauenklinik Ulm - Frauenheilkunde und Geburtshilfe

    RECRUITING

    Ulm, Baden-Wurttemberg, 89075, Germany

  • Universitätsklinikum Augsburg, Brustzentrum

    RECRUITING

    Augsburg, Bavaria, 86156, Germany

  • Universitätsklinikum Bonn Frauenheilkunde

    ACTIVE_NOT_RECRUITING

    Bonn, North Rhine-Westphalia, 53127, Germany

  • Universitätsklinikum Bonn, Senologie

    RECRUITING

    Bonn, North Rhine-Westphalia, 53127, Germany

  • Universitätsklinikum Erlangen

    ACTIVE_NOT_RECRUITING

    Erlangen, Erlangen, 91054, Germany

  • ViDia Christliche Kliniken Karlsruhe

    RECRUITING

    Karlsruhe, Baden-Wüttemberg, 76135, Germany

  • Ärztehaus am Bahnhofsplatz

    RECRUITING

    Hildesheim, Lower Saxony, 31134, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.