RecruitingPhase 3NCT06081244

NeoAdj. Therapy Comparing Sacituzumab Govitecan (SG) vs. SG+Pembrolizumab in Low-risk, Triple-neg. EBC (ADAPT-TN-III)

NeoAdjuvant Dynamic Marker - Adjusted Personalized Therapy Comparing Sacituzumab Govitecan Versus Sacituzumab Govitecan+Pembrolizumab in Low-risk, Triple-negative Early Breast Cancer (ADAPT-TN-III)


Sponsor

West German Study Group

Enrollment

348 participants

Start Date

Oct 10, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

TNBC is known for poor prognosis, aggressive patterns of disease, and significant molecular heterogeneity. (Neo)adjuvant chemotherapy (NACT) is standard of care in all node-positive and in node-negative patients with a tumour size \>5 mm according to current National Comprehensive Cancer Network (NCCN) guidelines. However, TNBC patients with lower stage disease do clearly have a better prognosis compared to more advanced stages. Patients with stage I-II node-negative disease have 3-5 year iDFS rates of 80-90% (with majority of relapses within the first three years) as shown in several trials.Although survival results appear much better in the lower vs. higher stages, there is a high clinical need in this most common group of TNBC patients in Western Europe and USA.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two neoadjuvant (pre-surgery) treatment approaches for patients with triple-negative breast cancer that is considered low-risk. One group receives a targeted antibody-drug treatment (sacituzumab govitecan), and the other also adds an immunotherapy drug (pembrolizumab). The goal is to shrink the tumor before surgery. **You may be eligible if...** - You have been diagnosed with triple-negative breast cancer (hormone receptor negative and HER2 negative) - Your cancer is early stage (clinical stage I, or stage II if standard chemotherapy isn't suitable) - You have no evidence of cancer spread to other parts of the body - You are 18 or older - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - You have a history of any invasive breast cancer - You are pregnant or breastfeeding - You have active HIV, hepatitis B, or hepatitis C infection - You have severe nerve damage (neuropathy grade 2 or higher) - You have serious uncontrolled infections or immune deficiency conditions - You have a history of lung inflammation (pneumonitis) that required treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSacituzumab govitecan

10 mg/kg twice on Days 1 and 8 of a continuous 21-day treatment cycle

DRUGPembrolizumab

200 mg every 3 weeks (q3w)


Locations(42)

Stadtklinik Baden-Baden / Brustzentrum

Baden-Baden, Baden-Wurttemberg, Germany

Kliniken Böblingen

Böblingen, Baden-Wurttemberg, Germany

Praxis für interdisziplinäre Onkologie & Hämatologie

Freiburg im Breisgau, Baden-Wurttemberg, Germany

SLK Kliniken Heilbronn, Frauenklinik

Heilbronn, Baden-Wurttemberg, Germany

Universitätsklinikum Tübingen

Tübingen, Baden-Wurttemberg, Germany

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany

GRN Klinik Weinheim

Weinheim, Baden-Württembergs, Germany

Hämatologie-Onkologie im Zentrum MVZ GmbH

Augsburg, Bavaria, Germany

Universitätsklinikum Augsburg A.ö.R.

Augsburg, Bavaria, Germany

Rotkreuzklinikum München

München, Bavaria, Germany

DBZ Onkologie GmbH

Berlin, Brandenburg, Germany

Klinikum Ernst von Bergmann gGmbH

Potsdam, Brandenburg, Germany

Klinikum Bremerhaven Reinkenheide gGmbH

Bremerhaven, Free Hanseatic City of Bremen, Germany

AGAPLESION Markus Krankenhaus

Frankfurt am Main, Hesse, Germany

MVZ II der Niels Stensen Kliniken

Georgsmarienhütte, Lower Saxony, Germany

Gynäkologische Gemeinschaftspraxis-Ärztehaus am Bahnhofsplatz

Hildesheim, Lower Saxony, Germany

Ev. Krankenhaus Berlin-Spandau

Berlin, North Rhine-Westphalia, Germany

Onkologische Schwerpunktpraxis Bielefeld

Bielefeld, North Rhine-Westphalia, Germany

St. Elisabeth-Krankenhaus Köln-Hohenlind

Cologne, North Rhine-Westphalia, Germany

Kliniken der Stadt Köln, Krankenhaus Holweide

Cologne, North Rhine-Westphalia, Germany

MVZ Medical Center Düsseldorf - GynOnco

Düsseldorf, North Rhine-Westphalia, Germany

St. - Antonius - Hospital

Eschweiler, North Rhine-Westphalia, Germany

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, Germany

Kliniken Essen-Mitte

Essen, North Rhine-Westphalia, Germany

ev. Klinikum Gelsenkirchen - Klinik für Senelogie

Gelsenkirchen, North Rhine-Westphalia, Germany

St. Barbara Klinik Hamm GmbH

Hamm, North Rhine-Westphalia, Germany

Klinikum Leverkusen gGmbH

Leverkusen, North Rhine-Westphalia, Germany

Ev. Krankenhaus Bethesda Brustzentrum Niederrhein

Mönchengladbach, North Rhine-Westphalia, Germany

MVZ MediaVita, St. Franziskus-Hospital Münster

Münster, North Rhine-Westphalia, Germany

MKS St.Paulus GmbH (ehem.Marienkrankenhaus)

Schwerte, North Rhine-Westphalia, Germany

Praxisnetzwerk Hämatologie und Onkologie, Troisdorf

Troisdorf, North Rhine-Westphalia, Germany

Marien Hospital Witten

Witten, North Rhine-Westphalia, Germany

Helios Universitätsklinikum Wuppertal Barmen

Wuppertal, North Rhine-Westphalia, Germany

Klinikum Mutterhaus-Trier

Trier, Rhineland-Palatinate, Germany

Caritasklinikum Saarbrücken

Saarbrücken, Saarland, Germany

Johanniter GmbH Johanniter Krankenhaus Stendal

Stendal, Sachsen-Anhalts, Germany

Klinikum Chemnitz gGmbH

Chemnitz, Saxony, Germany

Universitätsklinikum Leipzig

Leipzig, Saxony, Germany

Charité Campus Mitte Universitätsklinikum Berlin

Berlin, Germany

Hämatologisch/Onkologische Schwerpunktpraxis Bremen

Bremen, Germany

Mammazentrum Hamburg am Krankenhaus Jerusalem

Hamburg, Germany

Klinikum der Universität München

München, Germany

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NCT06081244


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