Tests a drug combination after surgery for triple negative breast cancer
Tests sacituzumab govitecan with pembrolizumab in adults with triple negative breast cancer left after surgery.
Plain-language title generated from the registry record
Registry title: Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63)
Key facts
- Where
- Augsburg, Berlin, Bielefeld, Bottrop, Braunschweig, Bremen, Cologne, Dortmund, Dresden, Duesseldorf, Erlangen, Essen, Frankfurt am Main, Frankfurt Am Main, Freiburg im Breisgau, Gelsenkirchen, Georgsmarienhuette, Gera, Hamburg, Jena, Karlsruhe, Kassel, Kiel, Koblenz, Krefeld, Langen (Hessen), Leipzig, Mannheim, Muehlhausen/thueringen, Muenster, Munich, Offenbach Am Main, Oldenburg, Paderborn, Potsdam, Ravensburg, Rostock, Schwerin, Stade, Stuttgart, Tuebingen, Ulm, Wiesbaden, Witten, Worms, and Wuppertal, GermanySee the 50 sites
- Phase
- Phase 3
Where in Germany
- Haematologie-Onkologie im Zentrum MVZ GmbHAugsburg, GermanyTaking people
- HELIOS Klinikum Berlin Buch GmbHBerlin, GermanyTaking people
- Praxisklinik Krebsheilkunde Fuer FrauenBerlin, GermanyTaking people
- Onkologische Schwerpunktpraxis BielefeldBielefeld, GermanyTaking people
- Knappschaft Kliniken Bottrop GmbHBottrop, GermanyTaking people
- Studien GbR BraunschweigBraunschweig, GermanyTaking people
- Gesundheit Nord gGmbH Klinikverbund BremenBremen, GermanyTaking people
- Hämato-Onkologische Praxis im MedicumBremen, GermanyTaking people
- St. Elisabeth Krankenhaus GmbHCologne, GermanyTaking people
- Kath. St. Paulus GmbHDortmund, GermanyTaking people
- Technische Universitaet DresdenDresden, GermanyTaking people
- Kostara Gyn. Oncology Clinic Research UG (haftungsbeschraenkt)Duesseldorf, GermanyTaking people
- Universitaetsklinikum Erlangen AöRErlangen, GermanyTaking people
- KEM I Evang. Kliniken Essen-Mitte gGmbHEssen, GermanyTaking people
- Agaplesion Frankfurter Diakonie Kliniken gGmbHFrankfurt am Main, GermanyTaking people
- Klinikum Frankfurt Hoechst GmbHFrankfurt Am Main, GermanyTaking people
- Medical Center- University of FreiburgFreiburg im Breisgau, GermanyTaking people
- Evangelische Kliniken Gelsenkirchen GmbHGelsenkirchen, GermanyTaking people
- Franziskus Hospital HarderbergGeorgsmarienhuette, GermanyTaking people
- SRH Wald-Klinikum Gera GmbHGera, GermanyTaking people
- Mammazentrum Hamburg MVZ GbRHamburg, GermanyTaking people
- ÜBAG Dres. Wierecky & BrandlHamburg, GermanyTaking people
- Universitaetsklinikum Jena KöRJena, GermanyTaking people
- ViDia Christliche Kliniken Karlsruhe Vincentius-Diakonissen-Kliniken gAGKarlsruhe, GermanyTaking people
- Elisabeth Krankenhaus GmbHKassel, GermanyTaking people
- Universitaetsklinikum Schleswig-Holstein AöRKiel, GermanyTaking people
- Institut fuer Versorgungsforschung in der Onkologie GbRKoblenz, GermanyTaking people
- MVZ GynKrefeld GmbHKrefeld, GermanyTaking people
- Gemeinschaftspraxis Fuer Haematologie Und OnkologieLangen (Hessen), GermanyTaking people
- ST. ELISABETH-KRANKENHAUS LEIPZIG gGmbH des Katholischen Kirchenlehens St. TrinitatisLeipzig, GermanyTaking people
- Universitaet LeipzigLeipzig, GermanyTaking people
- Universitat HeidelbergMannheim, GermanyTaking people
- Dr. Busch MVZ GmbHMuehlhausen/thueringen, GermanyTaking people
- Universitaet MuensterMuenster, GermanyTaking people
- Rotkreuzklinikum Muenchen gGmbHMunich, GermanyTaking people
- Sana Klinikum Offenbach GmbHOffenbach Am Main, GermanyTaking people
- Klinikum Oldenburg AorOldenburg, GermanyTaking people
- St. Vincenz-Krankenhaus GmbHPaderborn, GermanyTaking people
- Klinikum Ernst von Bergmann gGmbHPotsdam, GermanyTaking people
- MVZ fuer Haematologie und Onkologie Ravensburg GmbHRavensburg, GermanyTaking people
- Klinikum Suedstadt RostockRostock, GermanyTaking people
- HELIOS Kliniken Schwerin GmbHSchwerin, GermanyTaking people
- Klinik Dr. Hancken GmbHStade, GermanyTaking people
- Vinzenz Von Paul Kliniken gGmbHStuttgart, GermanyTaking people
- Universitaetsklinikum Tuebingen AöRTuebingen, GermanyTaking people
- Universitaetsklinikum Ulm AoRUlm, GermanyTaking people
- St. Josefs-Hospital Wiesbaden GmbHWiesbaden, GermanyTaking people
- Marien Hospital WittenWitten, GermanyTaking people
- Klinikum Worms gGmbHWorms, GermanyTaking people
- Helios Universitaetsklinikum WuppertalWuppertal, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Gilead Sciences
- Trial code
- NCT05633654EU 2024-512279-10-00
- Record updated
- 4 November 2026
- Original description
The goal of this study is to find out if the experimental product, sacituzumab govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician's choice (TPC) which includes either pembrolizumab or pembrolizumab plus capecitabine in participants with triple negative breast cancer that still remains after surgery and pre-surgical treatment.Read full original descriptionShow less
A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy
The goal of this study is to find out if the experimental product, sacituzumab govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician's choice (TPC) which includes either pembrolizumab or pembrolizumab plus capecitabine in participants with triple negative breast cancer that still remains after surgery and pre-surgical treatment.
Inclusion: Age > 18 years, with residual invasive triple negative breast cancer (TNBC) in the breast or lymph nodes after neoadjuvant therapy and surgery:; TNBC criteria for the study is defined as estrogen receptor (ER) and progesterone receptor (PR) ≤ 10%, human epidermal growth factor receptor 2 (HER2)-negative per American Society of Clinical Oncology and College of American Pathologists (ASCO/CAP) guidelines (immunohistochemistry (IHC) and/or in situ hybridization (ISH)); Adequate excision and surgical removal of all clinically evident of disease in the breast and/or lymph nodes and have adequately recovered from surgery; Submission of both pre-neoadjuvant treatment diagnostic biopsy and resected residual invasive disease tissue; Eastern Cooperative Oncology Group (ECOG) performance status 0-1; Individuals must have received appropriate radiotherapy aligned with local/institutional practice and have recovered prior to starting study treatment; Adequate organ function.
Exclusion: Stage IV (metastatic) breast cancer as well as history of any prior (ipsi- or contralateral) invasive breast cancer; Prior treatment with topoisomerase 1 inhibitors or antibody-drug conjugates (ADCs) containing a topoisomerase inhibitor; Evidence of recurrent disease following preoperative therapy and surgery; Individuals with germline breast cancer gene (BRCA) mutations; Active serious infections requiring anti-microbial therapy; Note: Other protocol defined Inclusion/Exclusion criteria may apply; Prior treatment with another stimulatory or coinhibitory T-cell receptor agent (eg, cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), OX-40, cluster of differentiation 137 (CD137), prior treatment with any HER2-directed agent, prior endocrine therapy for > 4 weeks or planned concurrent endocrine therapy while receiving on-study treatment; Myocardial infarction or unstable angina pectoris within 6 months of enrollment or history of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias or Left ventricular ejection fraction (LVEF) of < 50%.