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New hope for early breast cancer: targeted therapy may replace chemo

NCT ID NCT06081244

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 04, 2026 · Updated 2 times

Summary

This phase 3 trial is testing whether a targeted drug called sacituzumab govitecan (Trodelvy), alone or combined with the immunotherapy pembrolizumab (Keytruda), can effectively treat low-risk triple-negative breast cancer before surgery. The study aims to see if these drugs can eliminate the tumor better than standard chemotherapy. About 348 patients with early-stage, node-negative disease will participate.

What this could mean

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

Active substance
Sacituzumab govitecan (Trodelvy) and pembrolizumab (Keytruda)
What this could lead to
If successful, this could offer a more targeted, less toxic treatment option for early-stage triple-negative breast cancer, potentially improving cure rates without standard chemotherapy.
What could go wrong
This is an early-phase trial with a relatively small number of participants. The combination may not prove more effective than the single drug, and side effects from immunotherapy could be significant.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 348 people

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

Started

Oct 2024

Expected to finish

Sep 2029

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: 1. ER + PR negative or low positive (≤10% positive cells in IHC), and HER2 negative (i.e., IHC 0 - 1+ or IHC 2+ with FISH negative) breast cancer 2. All patients, independent from gender 3. ≥18 years at diagnosis 4. Histologically confirmed unilateral, primary invasive carcinoma of the breast Note: bilateral, multicentric, or multifocal carcinoma may be included, if there is a clear target lesion, that is subject to treatment decisions and solely evaluated and documented for study purposes. 5. Clinical stage I: cT1a-c, cN0 (clinical stage II only, if patient does not qualify for neoadjuvant polychemotherapy+PEM, e.g., elderly population, per investigator´s decision) 6. No clinical evidence for distant metastasis (M0) 7. Tumour block available for central pathology review 8. Performance Status ECOG ≤ 1 or KI ≥ 80% 9. Negative pregnancy test (urine or serum) within 7 days prior to registration in premenopausal patients 10. Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements 11. The patient must be willing and able to comply with the requirements and restrictions in this protocol and accessible for treatment and follow-up 12. Laboratory requirements: * Leucocytes ≥3.5 109/L, * Neutrophils \> 1.5 109/L, * Platelets ≥100 109/L, * Haemoglobin ≥10 g/dL, * AP \< 5.0 ULN, * AST ≤2.5 x ULN, * ALT ≤2.5 x ULN, * Total bilirubin ≤1 x ULN, * Creatinine ≤1.5 × ULN OR clearance ≥30 mL/min for participant with creatinine levels \>1.5 × institutional ULN 13. Clinical assessments: • LVEF within normal limits of each institution, measured by echocardiography and normal ECG (within 42 days prior to treatment) 14. The following age-specific requirements apply: * Women aged \<50 years will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the post-menopausal range for the site. * Women aged ≥ 50 years will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatments. 15. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods outlined for women of child-bearing potential if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to randomization/study enrolment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method. 16. Female patients of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception, presented in Table 1 (see Section 4.4.2), from the time of screening and must agree to continue using such precautions for 7 months after the last dose of IMP. Not all methods of contraception are highly effective. Female patients must refrain from breastfeeding while on study and for 7 months after the last dose of IMP. Complete heterosexual abstinence for the duration of the study and drug washout period is an acceptable contraceptive method if it is line with the patient's usual lifestyle (consideration must be made to the duration of the clinical trial); however, periodic, or occasional abstinence, the rhythm method, and the withdrawal method are not acceptable. 17. Female patients 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. They should refrain from breastfeeding throughout this time. Preservation of ova may be considered prior to enrolment in this study. 18. A male participant must agree to use a contraception as detailed in Appendix C of this protocol during the treatment period and for at least 7 months after the last dose of study treatment and refrain from donating sperm during this period. Exclusion Criteria: 1. Known hypersensitivity reaction to the compounds or incorporated substances of the IMPs 2. Prior malignancy with a disease-free survival of \< 5 years, except curatively treated basalioma of the skin or pTis of the cervix uteri 3. Any history of invasive breast cancer 4. Previous or concurrent treatment with cytotoxic agents for any non-oncological reason unless clarified with sponsor 5. Concurrent treatment with other experimental drugs 6. Participation in another interventional clinical trial with or without any investigational not marketed drug within 30 days prior to study entry 7. Concurrent pregnancy; patients of childbearing potential or potentially childbearing partners of male patients must implement a highly effective (less than 1% failure rate) non-hormonal contraceptive measures during the study treatment 8. Breast feeding woman 9. Reasons indicating risk of poor compliance 10. Patients not able to consent 11. Known polyneuropathy ≥ grade 2 12. Severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the study including recovery from major surgery, autoimmune disease, known psychiatric/substance abuse disorders, acute cystitis, ischuria, and chronic kidney disease 13. Uncontrolled infection requiring i.v. antibiotics, antivirals, or antifungals 14. History of pneumonitis 15. 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). 16. Have active hepatitis B virus (HBV) or hepatitis C virus (HCV). In patients with a history of HBV or HCV, patients with detectable viral loads will be excluded. * Patients who test positive for hepatitis B surface antigen (HBsAg). Patients who test positive for hepatitis B core antibody (anti-HBc) will require HBV DNA by quantitative polymerase chain reaction (PCR) for confirmation of active disease. * Patients who test positive for HCV antibody will require HCV RNA by quantitative PCR for confirmation of active disease. Patients with a known history of HCV or a positive HCV antibody test will not require a HCV antibody at screening and will only require HCV RNA by quantitative PCR for confirmation of active disease. 17. Patients who test positive for HIV antibody.

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Conditions

The condition(s) this trial relates to.

breast neoplasm triple-negative breast carcinoma

As listed by the trial registrant

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

Triple-negative 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

    40 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

    RECRUITING

    Frankfurt am Main, Hesse, 60431, Germany

  • Caritasklinikum Saarbrücken

    ACTIVE_NOT_RECRUITING

    Saarbrücken, Saarland, 66113, Germany

  • Charité Campus Mitte Universitätsklinikum Berlin

    SUSPENDED

    Berlin, State of Berlin, 10117, Germany

  • DBZ Onkologie GmbH

    RECRUITING

    Berlin, Brandenburg, 12623, Germany

  • Ev. Krankenhaus Berlin-Spandau

    RECRUITING

    Berlin, North Rhine-Westphalia, 13589, Germany

  • Ev. Krankenhaus Bethesda Brustzentrum Niederrhein

    RECRUITING

    Mönchengladbach, North Rhine-Westphalia, 41061, Germany

  • GRN Klinik Weinheim

    RECRUITING

    Weinheim, Baden-Württembergs, 69469, Germany

  • Gyn. Oncology Clinic Research UG

    RECRUITING

    Düsseldorf, North Rhine-Westphalia, 40235, Germany

  • Gynäkologische Gemeinschaftspraxis-Ärztehaus am Bahnhofsplatz

    RECRUITING

    Hildesheim, Lower Saxony, 31134, Germany

  • Helios Universitätsklinikum Wuppertal Barmen

    RECRUITING

    Wuppertal, North Rhine-Westphalia, 42283, Germany

  • Hämatologie-Onkologie im Zentrum MVZ GmbH

    RECRUITING

    Augsburg, Bavaria, 86150, Germany

  • Hämatologisch/Onkologische Schwerpunktpraxis Bremen

    RECRUITING

    Bremen, Free Hanseatic City of Bremen, 28209, Germany

  • Johanniter GmbH Johanniter Krankenhaus Stendal

    RECRUITING

    Stendal, Sachsen-Anhalts, 39576, Germany

  • Kliniken Böblingen

    RECRUITING

    Böblingen, Baden-Wurttemberg, 71032, Germany

  • Kliniken Essen-Mitte

    RECRUITING

    Essen, North Rhine-Westphalia, 45136, Germany

  • Kliniken der Stadt Köln, Krankenhaus Holweide

    RECRUITING

    Cologne, North Rhine-Westphalia, 51067, Germany

  • Klinikum Bremerhaven Reinkenheide gGmbH

    SUSPENDED

    Bremerhaven, Free Hanseatic City of Bremen, 27574, Germany

  • Klinikum Chemnitz gGmbH

    RECRUITING

    Chemnitz, Saxony, 09116, Germany

  • Klinikum Ernst von Bergmann gGmbH

    RECRUITING

    Potsdam, Brandenburg, 14467, Germany

  • Klinikum Leverkusen gGmbH

    RECRUITING

    Leverkusen, North Rhine-Westphalia, 51375, Germany

  • Klinikum Mutterhaus-Trier

    RECRUITING

    Trier, Rhineland-Palatinate, 54290, Germany

  • Klinikum der Universität München

    RECRUITING

    München, München, 80336, Germany

  • MKS St.Paulus GmbH (ehem.Marienkrankenhaus)

    RECRUITING

    Schwerte, North Rhine-Westphalia, 58239, Germany

  • MVZ II der Niels Stensen Kliniken

    RECRUITING

    Georgsmarienhütte, Lower Saxony, 49124, Germany

  • MVZ MediaVita, St. Franziskus-Hospital Münster

    RECRUITING

    Münster, North Rhine-Westphalia, 48145, Germany

  • MVZ Medical Center Düsseldorf - GynOnco

    TERMINATED

    Düsseldorf, North Rhine-Westphalia, 40235, Germany

  • Mammazentrum Hamburg am Krankenhaus Jerusalem

    RECRUITING

    Hamburg, Free and Hanseatic City of Hamburg, 20357, Germany

  • Marien Hospital Witten

    RECRUITING

    Witten, North Rhine-Westphalia, 58452, Germany

  • Onkologische Schwerpunktpraxis Bielefeld

    RECRUITING

    Bielefeld, North Rhine-Westphalia, 33604, Germany

  • Praxis für interdisziplinäre Onkologie & Hämatologie

    RECRUITING

    Freiburg im Breisgau, Baden-Wurttemberg, 79110, Germany

  • Praxisnetzwerk Hämatologie und Onkologie, Troisdorf

    RECRUITING

    Troisdorf, North Rhine-Westphalia, 53840, Germany

  • Rotkreuzklinikum München

    ACTIVE_NOT_RECRUITING

    München, Bavaria, 80637, Germany

  • SLK Kliniken Heilbronn, Frauenklinik

    RECRUITING

    Heilbronn, Baden-Wurttemberg, 74078, Germany

  • St. - Antonius - Hospital

    RECRUITING

    Eschweiler, North Rhine-Westphalia, 52249, Germany

  • St. Barbara Klinik Hamm GmbH

    RECRUITING

    Hamm, North Rhine-Westphalia, 59073, Germany

  • St. Elisabeth-Krankenhaus Köln-Hohenlind

    RECRUITING

    Cologne, North Rhine-Westphalia, 50935, Germany

  • Stadtklinik Baden-Baden / Brustzentrum

    RECRUITING

    Baden-Baden, Baden-Wurttemberg, 76532, Germany

  • Universitätsklinikum Augsburg A.ö.R.

    RECRUITING

    Augsburg, Bavaria, 86156, Germany

  • Universitätsklinikum Essen

    RECRUITING

    Essen, North Rhine-Westphalia, 45130, Germany

  • Universitätsklinikum Leipzig

    RECRUITING

    Leipzig, Saxony, 04103, Germany

  • Universitätsklinikum Tübingen

    RECRUITING

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • Universitätsklinikum Ulm

    RECRUITING

    Ulm, Baden-Wurttemberg, 89075, Germany

  • ev. Klinikum Gelsenkirchen - Klinik für Senelogie

    RECRUITING

    Gelsenkirchen, North Rhine-Westphalia, 45879, Germany

More trials for these conditions

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