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New drug combo could spare chemo for some breast cancer patients

NCT ID NCT05704829

Disease control Sponsor: West German Study Group 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests a personalized treatment plan for people with HER2-positive early breast cancer. It compares a newer drug (trastuzumab-deruxtecan) against standard chemotherapy combinations to see which works better and causes fewer side effects. About 702 participants will receive treatment before surgery, and researchers will track tumor response and long-term outcomes.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 702 people

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

Started

Feb 2024

Expected to finish

Sep 2030

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.

Ages

18 years and older

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 eligible for inclusion in this study must meet all the following criteria: 1\. Female patients with invasive, untreated HER2+ breast cancer (as assessed by local pathology) maximum 6 weeks before registration (standard-of-care diagnostic biopsy according to current AGO guidelines) 2. Age ≥18 years 3a. Cohort 1: low- to intermediate-risk for recurrence as per investigator´s decision (recommendation: cT1c - cT2 (1 - ≤3cm) AND cN0; cT1a/b, cN0 excluded), OR 3b. Cohort 2: intermediate- to high-risk for recurrence as per investigator´s decision (recommendation: cT2 (\>3 - ≤5cm), cN0) 3c. Cohort 3: intermediate- to high-risk for recurrence as per investigator´s decision, (recommendation: clinical stage II (cT2, cN0); cT1c, cN0 only if neoadjuvant treatment intended) 4. Written informed consent 5. LVEF ≥ 50% within 28 days before randomisation 6. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1 7. Adequate bone marrow and organ function within 14 days before randomisation as defined by the following laboratory values: * absolute neutrophil count ≥ 1.5 × 109/L, * platelets ≥ 100 × 109/L, * haemoglobin ≥ 9.0 g/dL: * estimated glomerular filtration rate (eGFR) ≥ 30 mL/min by a Cockcroft-Gault formula, * INR ≤ 1.5, * serum creatinine \< 1.5 mg/dL, * total bilirubin \< ULN, except for patients with Gilbert's Syndrome who may only be included if the total bilirubin is ≤ 3.0 × ULN or direct bilirubin ≤ 1.5 × ULN, * aspartate transaminase (AST) \< 2.5 × ULN, * alanine transaminase (ALT) \< 2.5 × ULN. 8. Adequate treatment washout period before randomisation (refer to protocol for detailed information) 9. Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential (refer to protocol for detailed information) Post-menopausal status is accepted for women, who at the time of initiation of study medication, either * had underwent bilateral oophorectomy, or * are ≥ 60 years of age, or * are \< 60 years of age and amenorrhoeic for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifen, or ovarian suppression) * and/or whose FSH- and oestradiol-blood values are within the postmenopausal range per local laboratory normal range. 10\. Female subjects must not donate, or retrieve for their own use, ova from the time of randomisation and throughout the study treatment period, and for at least 7 months after the final study drug administration. Exclusion Criteria: Patients eligible for inclusion in this study must not meet any of the following criteria: 1. 1\. Non-operable breast cancer including inflammatory breast cancer 2. cT1a/b, cN0 breast cancer 3. Any previous history of invasive breast cancer 4. Primary malignancies within 5 years, with the exception of * adequately resected non-melanoma skin cancer * curatively treated in-situ disease 5. Any evidence for existing metastatic disease (confirmed by CT Thorax/Abdomen, bone scan, or other methods according to clinical practice 6. Previous or concurrent treatment with cytotoxic agents for any reason (except non-oncological reasons) 7. Concurrent treatment with other experimental drugs and participation in another clinical trial with any investigational drug within 30 days prior to study entry 8. Severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the study/inadequate organ function 9. Reasons indicating risk of poor compliance 10. Woman of child-bearing potential defined as a woman physiologically capable of becoming pregnant, and not using highly effective methods of contraception during the study treatment and for 7 months after stopping the treatment. 11. Use of oral (oestrogen and progesterone), transdermal, injected, or implanted hormonal methods of contraception as well as hormonal replacement therapy. 12. Has substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the investigator, interfere with the subject's participation in the clinical study or evaluation of the clinical study results. 13. Patients with a medical history of myocardial infarction (MI) within 6 months before randomisation, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV), Subjects with troponin levels above ULN at screening (as defined by the manufacturer), and without any myocardial related symptoms, should have a cardiologic consultation before enrolment to rule out MI. 14. Corrected QT interval (QTcF) prolongation to \> 470 msec (females) based on average of the screening 12-lead ECG. 15. History of (non-infectious) ILD / pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening. 16. Lung criteria: * Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder * Any autoimmune, connective tissue or inflammatory disorders (e.g., Rheumatoid arthritis, Sjogren's, sarcoidosis etc.) where there is documented, or a suspicion of pulmonary involvement at the time of randomisation. * Prior pneumonectomy (complete) * Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals 17. Active primary immunodeficiency, known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Patients should be tested for HIV prior to randomisation if required by local regulations or ethics committee (EC). 18. Receipt of live, attenuated vaccine (mRNA and replication deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first dose of trastuzumab deruxtecan or carboplatin. Note: Patients, if enrolled, should not receive live vaccine during the study and up to 30 days after the last dose of IMP. 19. Known allergy or hypersensitivity to study treatment (T-DXd), to comparator (SoC-) treatment, or any of the study drug / comparator (SoC-) excipients. 20. History of severe hypersensitivity reactions to other monoclonal antibodies. 21. Pregnant or breastfeeding female patients, or patients who are planning to become pregnant

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Conditions

The condition(s) this trial relates to.

HER2 positive breast carcinoma Recurrence

As listed by the trial registrant

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

HER2-positive early 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

    41 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 Markus Krankenhaus Gynäkologie

    RECRUITING

    Frankfurt am Main, Hesse, 60431, Germany

  • Breast Center of the University of Munich (LMU) Universitätsfrauenklinik

    RECRUITING

    Munich, Bavaria, 80336, Germany

  • Brustzentrum Niederrhein, Johanniter Bethesda Krankenhaus

    RECRUITING

    Mönchengladbach, North Rhine-Westphalia, 41061, Germany

  • Brustzentrum am Krankenhaus Jerusalem

    RECRUITING

    Hamburg, 20357, Germany

  • CaritasKlinikum Saarbrücken St. Theresia

    RECRUITING

    Saarbrücken, Saarland, 66113, Germany

  • Charite Campus Mitte

    ACTIVE_NOT_RECRUITING

    Berlin, 10117, Germany

  • Ev. Waldkrankenhaus Spandau

    RECRUITING

    Berlin, 14589, Germany

  • Frauenklinik / Brustzentrum am Klinikum Obergölzsch Rodewisch

    RECRUITING

    Rodewisch, Saxony, 08228, Germany

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

    RECRUITING

    Paderborn, North Rhine-Westphalia, 33098, Germany

  • Helios-Klinik Wuppertal

    RECRUITING

    Wuppertal, North Rhine-Westphalia, 42283, Germany

  • Hämotologisch onkologische Praxis Heinrich Bangerter Augsburg GbR

    RECRUITING

    Augsburg, Bavaria, 86150, Germany

  • Kliniken Essen-Mitte, Klinik für Senologie/Interdisziplinäres Brustzentrum

    RECRUITING

    Essen, North Rhine-Westphalia, 45136, Germany

  • Kliniken der Stadt Köln GmbH / Brustzentrum Holweide

    RECRUITING

    Cologne, North Rhine-Westphalia, 51067, Germany

  • Kliniken für Frauenheilkunde / Universitätsklinikum Düsseldorf

    RECRUITING

    Düsseldorf, North Rhine-Westphalia, 40225, Germany

  • Klinikum Bremerhaven Reinkenheide

    ACTIVE_NOT_RECRUITING

    Bremerhaven, Free Hanseatic City of Bremen, 27574, Germany

  • Klinikum Frankfurt Höchst GmbH

    RECRUITING

    Frankfurt am Main, Hesse, 65929, Germany

  • Klinikum Kassel

    RECRUITING

    Kassel, Hesse, 34125, Germany

  • Klinikum Mittelbaden, Brustzentrum

    RECRUITING

    Baden-Baden, Baden-Wurttemberg, 76532, Germany

  • Klinikum Mutterhaus

    RECRUITING

    Trier, Rhineland-Palatinate, 54290, Germany

  • Luisenkrankenhaus GmbH

    ACTIVE_NOT_RECRUITING

    Düsseldorf, North Rhine-Westphalia, 40235, Germany

  • MKS St. Paulus GmbH

    RECRUITING

    Schwerte, North Rhine-Westphalia, 58239, Germany

  • MVZ Klinik Dr. Hancken GmbH

    RECRUITING

    Stade, Lower Saxony, 21680, Germany

  • MVZ Media Vita am St. Franziskus Hospital

    RECRUITING

    Münster, North Rhine-Westphalia, 48145, Germany

  • Marien-Hospital Witten

    NOT_YET_RECRUITING

    Witten, North Rhine-Westphalia, 58452, Germany

  • Niels-Stensen-Kliniken Franziskus-Hospital

    RECRUITING

    Georgsmarienhütte, Lower Saxony, 49124, Germany

  • Onkodok Gütersloh

    RECRUITING

    Gütersloh, North Rhine-Westphalia, 33332, Germany

  • Onkologische Schwerpunktpraxis Bielefeld

    RECRUITING

    Bielefeld, North Rhine-Westphalia, 33604, Germany

  • Praxis für Interdisziplinäre Onkologie und Hämatologie (PIO)

    RECRUITING

    Freiburg im Breisgau, Baden-Wurttemberg, 79110, Germany

  • Praxisnetzwerk Hämatologie und intern. Onkologie

    RECRUITING

    Troisdorf, North Rhine-Westphalia, 53840, Germany

  • Rotkreuz Klinikum München

    RECRUITING

    Munich, Bavaria, 80634, Germany

  • Sankt-Antonius-Hospital

    RECRUITING

    Eschweiler, North Rhine-Westphalia, 52249, Germany

  • St. Barbara Klinik

    RECRUITING

    Hamm, North Rhine-Westphalia, 59073, Germany

  • St. Elisabeth Krankenhaus GmbH

    RECRUITING

    Cologne, North Rhine-Westphalia, 50935, Germany

  • Studien GbR Braunschweig

    RECRUITING

    Braunschweig, Lower Saxony, 38100, Germany

  • UK Schleswig Holstein

    RECRUITING

    Lübeck, Schleswig-Holsteins, 23538, Germany

  • Uniklinik RWTH Aachen

    RECRUITING

    Aachen, North Rhine-Westphalia, 52074, Germany

  • Universittsklinikum am Klinikum Südstadt

    RECRUITING

    Rostock, Mecklenburg-Vorpommerns, 18059, Germany

  • Universitätsklinikum Augsburg / Klinik für Frauenheilkunde und Geburtshilfe

    RECRUITING

    Augsburg, Bavaria, 86156, Germany

  • Universitätsklinikum Essen, Brustzentrum

    RECRUITING

    Essen, North Rhine-Westphalia, 45147, Germany

  • Universitätsklinikum Hamburg-Eppendorf / Klinik und Poliklinik für Gynäkologie

    RECRUITING

    Hamburg, 20246, Germany

  • Universitätsklinikum Leipzig

    RECRUITING

    Leipzig, Saxony, 04103, Germany

  • Universitätsklinikum Tübingen

    RECRUITING

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • Universitätsklinikum Ulm

    RECRUITING

    Ulm, Baden-Wurttemberg, 89075, 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.