Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)

May 27, 2026 updated by: Merck Sharp & Dohme LLC

A Phase 3, Randomized, Open-label, Study to Compare the Efficacy and Safety of Adjuvant MK-2870 in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice (TPC) in Participants With Triple-Negative Breast Cancer (TNBC) Who Received Neoadjuvant Therapy and Did Not Achieve a Pathological Complete Response (pCR) at Surgery

This is a randomized, open-label study comparing the efficacy and safety of adjuvant sacituzumab tirumotecan (MK-2870) in combination with pembrolizumab compared to treatment of physician's choice (TPC) in participants with triple-negative breast cancer (TNBC) who received neoadjuvant therapy and did not achieve a pathological complete response (pCR) at surgery. The primary objective is to compare sacituzumab tirumotecan plus pembrolizumab to TPC (pembrolizumab or pembrolizumab plus capecitabine) with respect to invasive disease-free survival (iDFS) per investigator assessment. It is hypothesized that sacituzumab tirumotecan plus pembrolizumab is superior to TPC with respect to iDFS per investigator assessment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1530

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1187AAN
        • Recruiting
        • Sanatorio Finochietto ( Site 0513)
        • Contact:
          • Study Coordinator
          • Phone Number: +54 113752-8000
      • Buenos Aires, Argentina, C1431FWO
        • Recruiting
        • Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 0508)
        • Contact:
          • Study Coordinator
          • Phone Number: +541152991580
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina, C1118AAT
        • Recruiting
        • Hospital Aleman-Oncology ( Site 0501)
        • Contact:
          • Study Coordinator
          • Phone Number: +541148277000
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1280AEB
        • Recruiting
        • Hospital Británico de Buenos Aires-Oncology ( Site 0502)
        • Contact:
          • Study Coordinator
          • Phone Number: +54911563819972
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., Argentina, C1417
        • Recruiting
        • Instituto de Oncología Angel H. Roffo ( Site 0503)
        • Contact:
          • Study Coordinator
          • Phone Number: 5491152375236
      • Buenos Aires, Buenos Aires F.D., Argentina, C1426ANZ
        • Recruiting
        • Instituto Alexander Fleming-Alexander Fleming ( Site 0509)
        • Contact:
          • Study Coordinator
          • Phone Number: +5491138850425
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000DSV
        • Recruiting
        • Sanatorio Parque ( Site 0512)
        • Contact:
          • Study Coordinator
          • Phone Number: 543414929663
  • Australia
    • New South Wales
      • Macquarie University, New South Wales, Australia, 2109
        • Recruiting
        • Macquarie University-MQ Health Clinical Trials Unit ( Site 2703)
        • Contact:
          • Study Coordinator
          • Phone Number: +61298122979
      • Westmead, New South Wales, Australia, 2145
        • Recruiting
        • Westmead Hospital ( Site 2700)
        • Contact:
          • Study Coordinator
          • Phone Number: +61288906728
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Recruiting
        • Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 2701)
        • Contact:
          • Study Coordinator
          • Phone Number: +610736470209
    • Victoria
      • Frankston, Victoria, Australia, 3199
        • Recruiting
        • Frankston Hospital-Oncology and Haematology ( Site 2704)
        • Contact:
          • Study Coordinator
          • Phone Number: +61397847777
  • Austria
      • Salzburg, Austria, 5020
        • Recruiting
        • Uniklinikum Salzburg-Universitätsklinik für Innere Medizin III der PMU mit Hämatologie, internistis ( Site 1202)
        • Contact:
          • Study Coordinator
          • Phone Number: +435725525826
      • Vienna, Austria, 1090
        • Recruiting
        • Medizinische Universität Wien-Universitätsklinik für Innere Medizin I, Klinische Abteilung für Onko ( Site 1201)
        • Contact:
          • Study Coordinator
          • Phone Number: +4314040064470
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Recruiting
        • Medizinische Universitaet Innsbruck ( Site 1200)
        • Contact:
          • Study Coordinator
          • Phone Number: +435050423079
    • Upper Austria
      • Linz, Upper Austria, Austria, 4020
        • Recruiting
        • Kepler Universitätsklinikum-Department for Oncology and Hematology ( Site 1206)
        • Contact:
          • Study Coordinator
          • Phone Number: +43576808373652
      • Wels, Upper Austria, Austria, 4600
        • Recruiting
        • Klinikum Wels-Grieskirchen ( Site 1205)
        • Contact:
          • Study Coordinator
          • Phone Number: +4372424150
  • Belgium
      • Namur, Belgium, 5530
        • Recruiting
        • Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 0902)
        • Contact:
          • Study Coordinator
          • Phone Number: +32 (0)81 42 38 53
    • Bruxelles-Capitale, Region de
      • Brussels, Bruxelles-Capitale, Region de, Belgium, 1200
        • Recruiting
        • Cliniques universitaires Saint-Luc-Medical Oncology ( Site 0901)
        • Contact:
          • Study Coordinator
          • Phone Number: 02 764 42 14
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • Recruiting
        • AZ Maria Middelares-IKG ( Site 0903)
        • Contact:
          • Study Coordinator
          • Phone Number: +3292468464
  • Brazil
      • São Paulo, Brazil, 04014-002
        • Recruiting
        • IBCC - Núcleo de Pesquisa e Ensino ( Site 0601)
        • Contact:
          • Study Coordinator
          • Phone Number: +551144500300
    • Ceará
      • Fortaleza, Ceará, Brazil, 60810-180
        • Recruiting
        • PRONUTRIR-CLINICAL RESEARCH ( Site 0609)
        • Contact:
          • Study Coordinator
          • Phone Number: +558530480533
    • Piauí
      • Teresina, Piauí, Brazil, 64049-200
        • Recruiting
        • Oncoclínica Oncologistas Associados-Clinical Research ( Site 0607)
        • Contact:
          • Study Coordinator
          • Phone Number: +5586999007799
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90110-270
        • Recruiting
        • Hospital do Câncer Mãe de Deus ( Site 0604)
        • Contact:
          • Study Coordinator
          • Phone Number: +555133072943
      • Santa Cruz do Sul, Rio Grande do Sul, Brazil, 96830-180
        • Recruiting
        • Instituto de Oncologia Saint Gallen ( Site 0614)
        • Contact:
          • Study Coordinator
          • Phone Number: +55513056-8686
    • São Paulo
      • Taubaté, São Paulo, Brazil, 12030-200
        • Recruiting
        • Instituto do Câncer Brasil - Unidade Taubaté ( Site 0608)
        • Contact:
          • Study Coordinator
          • Phone Number: +551236318559
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Recruiting
        • Cross Cancer Institute ( Site 0407)
        • Contact:
          • Study Coordinator
          • Phone Number: 7804328956
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Recruiting
        • BC Cancer Vancouver ( Site 0404)
        • Contact:
          • Study Coordinator
          • Phone Number: 6048776000
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • Recruiting
        • CancerCare Manitoba ( Site 0411)
        • Contact:
          • Study Coordinator
          • Phone Number: 2047872127
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6Z8
        • Recruiting
        • The Moncton Hospital ( Site 0401)
        • Contact:
          • Study Coordinator
          • Phone Number: 5068575756
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Recruiting
        • QEII Health Sciences Centre - Victoria General Site ( Site 0418)
        • Contact:
          • Study Coordinator
          • Phone Number: 9024732160
    • Ontario
      • Newmarket, Ontario, Canada, L3Y 2P9
        • Recruiting
        • Southlake Health ( Site 0413)
        • Contact:
          • Study Coordinator
          • Phone Number: 9058954521x5155
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • The Ottawa Hospital - General Campus ( Site 0414)
        • Contact:
          • Study Coordinator
          • Phone Number: 6137377700x70208
      • Toronto, Ontario, Canada, M2K 1E1
        • Recruiting
        • North York General Hospital ( Site 0415)
        • Contact:
          • Study Coordinator
          • Phone Number: 4167566000
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre ( Site 0400)
        • Contact:
          • Study Coordinator
          • Phone Number: 4169464501x2245
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Recruiting
        • Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0417)
        • Contact:
          • Study Coordinator
          • Phone Number: 4504665000x3226
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Jewish General Hospital ( Site 0416)
        • Contact:
          • Study Coordinator
          • Phone Number: 5143405222x27562
      • Montreal, Quebec, Canada, H1T 2M4
        • Recruiting
        • CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0419)
        • Contact:
          • Study Coordinator
          • Phone Number: 5142523400x6244
      • Montreal, Quebec, Canada, H2X 3E4
        • Recruiting
        • Centre Hospitalier de l'Université de Montréal ( Site 0403)
        • Contact:
          • Study Coordinator
          • Phone Number: 5148908000
      • Rimouski, Quebec, Canada, G5L 5T1
        • Recruiting
        • Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski ( Site 0409)
        • Contact:
          • Study Coordinator
          • Phone Number: 4187243000x8029
      • Trois-Rivières, Quebec, Canada, G8Z 3R9
        • Recruiting
        • Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-centre-du-quebec ( Site 0406)
        • Contact:
          • Study Coordinator
          • Phone Number: 8196973333x63238
  • Colombia
    • Antioquia
      • Rionegro, Antioquia, Colombia, 054040
        • Recruiting
        • Clinica Somer ( Site 3704)
        • Contact:
          • Study Coordinator
          • Phone Number: 57 3125891661
    • Bogota D.C.
      • Bogotá, Bogota D.C., Colombia, 110131
        • Recruiting
        • FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 3700)
        • Contact:
          • Study Coordinator
          • Phone Number: +573183662238
      • Bogotá, Bogota D.C., Colombia, 111511
        • Recruiting
        • Instituto Nacional De Cancerologia ( Site 3701)
        • Contact:
          • Study Coordinator
          • Phone Number: 57 3145017596
    • Cesar Department
      • Valledupar, Cesar Department, Colombia, 200001
        • Recruiting
        • Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 3705)
        • Contact:
          • Study Coordinator
          • Phone Number: +5715602310
  • Czechia
    • Brno-mesto
      • Brno, Brno-mesto, Czechia, 656 53
        • Recruiting
        • Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 1005)
        • Contact:
          • Study Coordinator
          • Phone Number: +420543134000
    • Olomouc Region
      • Olomouc, Olomouc Region, Czechia, 779 00
        • Recruiting
        • Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 1006)
        • Contact:
          • Study Coordinator
          • Phone Number: +420588444295
    • Praha 2
      • Prague, Praha 2, Czechia, 128 08
        • Recruiting
        • Vseobecna fakultni nemocnice v Praze-Onkologická klinika VFN ( Site 1002)
        • Contact:
          • Study Coordinator
          • Phone Number: +420224966763
    • Praha 4
      • Prague, Praha 4, Czechia, 14059
        • Recruiting
        • Fakultni Thomayerova nemocnice - Onkologicka klinika 1. LF UK a FTN ( Site 1008)
        • Contact:
          • Study Coordinator
          • Phone Number: +420261083733
    • Praha 5
      • Prague, Praha 5, Czechia, 150 06
        • Recruiting
        • Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 1000)
        • Contact:
          • Study Coordinator
          • Phone Number: +420224434701
    • South Bohemian Region
      • České Budějovice, South Bohemian Region, Czechia, 37001
        • Recruiting
        • Nemocnice Ceske Budejovice-Onkologicke oddeleni ( Site 1007)
        • Contact:
          • Study Coordinator
          • Phone Number: +420387875001
  • Denmark
    • Capital Region
      • Herlev, Capital Region, Denmark, 2730
        • Recruiting
        • Herlev og Gentofte Hospital. ( Site 3203)
        • Contact:
          • Study Coordinator
          • Phone Number: 00 45 38689193
    • Central Jutland
      • Aarhus N, Central Jutland, Denmark, 8200
        • Recruiting
        • Aarhus Universitets hospital ( Site 3202)
        • Contact:
          • Study Coordinator
          • Phone Number: +4578450000
    • North Denmark
      • Aalborg, North Denmark, Denmark, 9000
        • Recruiting
        • Aalborg Universitetshospital, Syd ( Site 3206)
        • Contact:
          • Study Coordinator
          • Phone Number: +4597661400
    • Region Syddanmark
      • Odense C, Region Syddanmark, Denmark, 5000
        • Recruiting
        • Odense Universitetshospital ( Site 3201)
        • Contact:
          • Study Coordinator
          • Phone Number: +4566113333
      • Sønderborg, Region Syddanmark, Denmark, 6400
        • Recruiting
        • Sygehus Soenderjylland ( Site 3204)
        • Contact:
          • Study Coordinator
          • Phone Number: +4579970000
      • Vejle, Region Syddanmark, Denmark, 7100
        • Recruiting
        • Vejle Sygehus. ( Site 3205)
        • Contact:
          • Study Coordinator
          • Phone Number: 00 45 79406060
  • Finland
    • Northern Savonia
      • Kuopio, Northern Savonia, Finland, 70210
        • Recruiting
        • Kuopion Yliopistollinen Sairaala-Syöpäkeskus ( Site 1101)
        • Contact:
          • Study Coordinator
          • Phone Number: +35817173311
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, 33520
        • Recruiting
        • Tampereen yliopistollinen sairaala ( Site 1102)
        • Contact:
          • Study Coordinator
          • Phone Number: +358331166764
    • Southwest Finland
      • Turku, Southwest Finland, Finland, 20520
        • Recruiting
        • Turku University Hospital-Department of Oncology ( Site 1103)
        • Contact:
          • Study Coordinator
          • Phone Number: +35823130721
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00029
        • Recruiting
        • Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1100)
        • Contact:
          • Study Coordinator
          • Phone Number: +358947174900
  • France
      • Paris, France, 75020
        • Recruiting
        • Hôpital Tenon ( Site 1303)
        • Contact:
          • Study Coordinator
          • Phone Number: +33156017825
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06189
        • Recruiting
        • Centre Antoine-Lacassagne ( Site 1308)
        • Contact:
          • Study Coordinator
          • Phone Number: +33492031000
    • Aquitaine
      • Bayonne, Aquitaine, France, 64109
        • Recruiting
        • Centre Hospitalier de la Côte Basque ( Site 1315)
        • Contact:
          • Study Coordinator
          • Phone Number: +33559443762
    • Auvergne
      • Clermont-Ferrand, Auvergne, France, 63011
        • Recruiting
        • Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 1307)
        • Contact:
          • Study Coordinator
          • Phone Number: 0473278005
    • Auvergne-Rhône-Alpes
      • Lyon Cedex08, Auvergne-Rhône-Alpes, France, 69373
        • Recruiting
        • CENTRE LEON BERARD ( Site 1300)
        • Contact:
          • Study Coordinator
          • Phone Number: +33478782644
    • Bouches-du-Rhone
      • Marseille, Bouches-du-Rhone, France, 13009
        • Recruiting
        • Institut Paoli-Calmettes ( Site 1309)
        • Contact:
          • Study Coordinator
          • Phone Number: +33491223611
    • Calvados
      • Caen, Calvados, France, 14076
        • Recruiting
        • Centre François Baclesse ( Site 1318)
        • Contact:
          • Study Coordinator
          • Phone Number: +33231455050
    • Cote-d Or
      • Dijon, Cote-d Or, France, 21079
        • Recruiting
        • Centre Georges François Leclerc ( Site 1312)
        • Contact:
          • Study Coordinator
          • Phone Number: 03 70 63 24 03
    • Doubs
      • Besançon, Doubs, France, 25000
        • Completed
        • CHU Besançon ( Site 1311)
    • Drome
      • Valence, Drome, France, 26000
        • Recruiting
        • Hôpital Privé Drôme-Ardèche ( Site 1301)
        • Contact:
          • Study Coordinator
          • Phone Number: +33475756604
    • Finistere
      • Brest, Finistere, France, 29200
        • Recruiting
        • CHRU Brest - Hopital Cavale Blanche ( Site 1304)
        • Contact:
          • Study Coordinator
          • Phone Number: +33230338161
    • Gironde
      • Bordeaux, Gironde, France, 33000
        • Recruiting
        • Clinique Tivoli Ducos ( Site 1322)
        • Contact:
          • Study Coordinator
          • Phone Number: +33556116296
    • Hauts-de-Seine
      • Levallois-Perret, Hauts-de-Seine, France, 92300
        • Recruiting
        • Hôpital Franco-Britannique - Fondation Cognacq-Jay ( Site 1321)
        • Contact:
          • Study Coordinator
          • Phone Number: +33147591915
    • Loire-Atlantique
      • Saint-Herblain, Loire-Atlantique, France, 44805
        • Recruiting
        • Institut de Cancérologie de l'Ouest ( Site 1305)
        • Contact:
          • Study Coordinator
          • Phone Number: +33240679900
    • Maine-et-Loire
      • Angers, Maine-et-Loire, France, 49055
        • Recruiting
        • Institut de Cancérologie de l'Ouest ( Site 1316)
        • Contact:
          • Study Coordinator
          • Phone Number: 02 41 35 27 00
    • Nord
      • Valenciennes, Nord, France, 59300
        • Recruiting
        • Centre de Cancerologie Les Dentellieres ( Site 1306)
        • Contact:
          • Study Coordinator
          • Phone Number: +33327091010
    • Pyrenees-Atlantiques
      • Pau, Pyrenees-Atlantiques, France, 64046
        • Recruiting
        • Centre Hospitalier de Pau ( Site 1302)
        • Contact:
          • Study Coordinator
          • Phone Number: +33559726996
    • Seine-Maritime
      • Rouen, Seine-Maritime, France, 76038
        • Recruiting
        • Centre Henri Becquerel ( Site 1319)
        • Contact:
          • Study Coordinator
          • Phone Number: 02 32 08 22 22
  • Germany
      • Berlin, Germany, 13125
        • Recruiting
        • Helios Klinikum Berlin-Buch-Klinik für Gynäkologie und Geburtshilfe ( Site 1413)
        • Contact:
          • Study Coordinator
          • Phone Number: +4930940113394
    • Baden-Wurttemberg
      • Ludwigsburg, Baden-Wurttemberg, Germany, 71640
        • Recruiting
        • Klinikum Ludwigsburg-Klinik für Geburtshilfe und Frauenheilkunde ( Site 1405)
        • Contact:
          • Study Coordinator
          • Phone Number: +4971419996433
      • Tübingen, Baden-Wurttemberg, Germany, 72076
        • Recruiting
        • Universitaetsklinikum Tuebingen-Frauenklinik ( Site 1415)
        • Contact:
          • Study Coordinator
          • Phone Number: +4970712964226
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • Recruiting
        • Universitaetsklinikum Erlangen-Klinik für Gynäkologie und Geburtshilfe ( Site 1400)
        • Contact:
          • Study Coordinator
          • Phone Number: +4991318533572
      • Munich, Bavaria, Germany, 80336
        • Recruiting
        • Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Frauenklinik Brustzentrum ( Site 1402)
        • Contact:
          • Study Coordinator
          • Phone Number: +4989440034645
    • Brandenburg
      • Potsdam, Brandenburg, Germany, 14467
        • Recruiting
        • Klinikum Ernst von Bergmann-Frauenklinik ( Site 1408)
        • Contact:
          • Study Coordinator
          • Phone Number: +493312415602
    • Lower Saxony
      • Georgsmarienhütte, Lower Saxony, Germany, 49124
        • Recruiting
        • Franziskus-Hospital Harderberg ( Site 1404)
        • Contact:
          • Study Coordinator
          • Phone Number: +495415022466
    • North Rhine-Westphalia
      • Düsseldorf, North Rhine-Westphalia, Germany, 40225
        • Recruiting
        • Universitaetsklinikum Duesseldorf-Klinik für Frauenheilkunde & Geburtshilfe ( Site 1409)
        • Contact:
          • Study Coordinator
          • Phone Number: +492118117506
      • Essen, North Rhine-Westphalia, Germany, 45136
        • Recruiting
        • Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung-Klinik für Senologie/ Brustzentrum ( Site 1401)
        • Contact:
          • Study Coordinator
          • Phone Number: +4920117433005
      • Mönchengladbach, North Rhine-Westphalia, Germany, 41061
        • Recruiting
        • Evangelisches Krankenhaus Bethesda Mönchengladbach-Brustzentrum Niederrhein ( Site 1406)
        • Contact:
          • Study Coordinator
          • Phone Number: +4921618493577
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Germany, 55131
        • Recruiting
        • Universitätsmedizin Johannes Gutenberg Universität Mainz-Klinik und Poliklinik für Geburtshilfe und ( Site 1418)
        • Contact:
          • Study Coordinator
          • Phone Number: +496131172683
    • Saarland
      • Saarbrücken, Saarland, Germany, 66113
        • Recruiting
        • CaritasKlinikum Saarbruecken St. Theresia ( Site 1410)
        • Contact:
          • Study Coordinator
          • Phone Number: +496814061345
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23538
        • Recruiting
        • Universitätsklinikum Schleswig-Holstein ( Site 1411)
        • Contact:
          • Study Coordinator
          • Phone Number: +4945150041930
  • Greece
      • Thessaloniki, Greece, 570 01
        • Recruiting
        • European Interbalkan Medical Center ( Site 1502)
        • Contact:
          • Study Coordinator
          • Phone Number: +302313252011
      • Thessaloniki, Greece, 570 01
        • Recruiting
        • European Interbalkan Medical Center ( Site 1507)
        • Contact:
          • Study Coordinator
          • Phone Number: +302310390671
    • Achaia
      • Pátrai, Achaia, Greece, 26504
        • Recruiting
        • UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 1509)
        • Contact:
          • Study Coordinator
          • Phone Number: +302610999791
    • Attica
      • Athens, Attica, Greece, 115 26
        • Recruiting
        • Errikos Dunant Hospital Center-1st Medical Oncology Dept. ( Site 1508)
        • Contact:
          • Study Coordinator
          • Phone Number: +302106972433
      • Athens, Attica, Greece, 115 28
        • Recruiting
        • Aretaieio Hospital Oncology Unit ( Site 1505)
        • Contact:
          • Study Coordinator
          • Phone Number: +302107286444
    • Thessaly
      • Larissa, Thessaly, Greece, 411 10
        • Recruiting
        • University General Hospital of Larissa ( Site 1503)
        • Contact:
          • Study Coordinator
          • Phone Number: +302413502785
  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Queen Mary Hospital ( Site 3600)
        • Contact:
          • Study Coordinator
          • Phone Number: +852 2255 3838
      • Kowloon, Hong Kong
        • Recruiting
        • Hong Kong United Oncology Centre ( Site 3601)
        • Contact:
          • Study Coordinator
          • Phone Number: +852 2386 8002
      • Shatin, Hong Kong, 000000
        • Recruiting
        • Prince of Wales Hospital ( Site 3602)
        • Contact:
          • Study Coordinator
          • Phone Number: + 852 3505 2211
  • Ireland
      • Cork, Ireland, T12 DV56
        • Recruiting
        • Bon Secours Cork Hospital ( Site 1600)
        • Contact:
          • Study Coordinator
          • Phone Number: +353214542807
      • Dublin, Ireland, D04 T6F4
        • Recruiting
        • St. Vincent's University Hospital-Medical Oncology Research Department ( Site 1601)
        • Contact:
          • Study Coordinator
          • Phone Number: +353 1 221 4982
      • Galway, Ireland, Galway
        • Recruiting
        • University College Hospital - Galway ( Site 1602)
        • Contact:
          • Study Coordinator
          • Phone Number: +35391524222
  • Israel
      • Beersheba, Israel, 8410101
        • Recruiting
        • Soroka Medical Center-Oncology ( Site 1704)
        • Contact:
          • Study Coordinator
          • Phone Number: 0507425629
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah Medical Center ( Site 1700)
        • Contact:
          • Study Coordinator
          • Phone Number: +972-2-6778510
      • Jerusalem, Israel, 9103102
        • Recruiting
        • Shaare Zedek Medical Center ( Site 1706)
        • Contact:
          • Study Coordinator
          • Phone Number: +97226555999
      • Petah Tikva, Israel, 4941492
        • Recruiting
        • Rabin Medical Center ( Site 1702)
        • Contact:
          • Study Coordinator
          • Phone Number: +972-3-9378076
      • Ramat Gan, Israel, 5265601
        • Recruiting
        • Sheba Medical Center-ONCOLOGY ( Site 1701)
        • Contact:
          • Study Coordinator
          • Phone Number: +972-35304436
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Sourasky Medical Center ( Site 1705)
        • Contact:
          • Study Coordinator
          • Phone Number: +972-3-6947557
  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1810)
        • Contact:
          • Study Coordinator
          • Phone Number: +39 0512144548
      • Milan, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele-Oncologia Medica ( Site 1814)
        • Contact:
          • Study Coordinator
          • Phone Number: +390226436530
      • Novara, Italy, 28100
        • Recruiting
        • Azienda Ospedaliero Universitaria Maggiore della Carità-SCDU ONCOLOGIA ( Site 1804)
        • Contact:
          • Study Coordinator
          • Phone Number: +3903213733822
    • Campania
      • Naples, Campania, Italy, 80100
        • Recruiting
        • University of Naples Federico II-Dipartimento di Medicina Clinica e Chirurgia ( Site 1803)
        • Contact:
          • Study Coordinator
          • Phone Number: +390817463772
      • Naples, Campania, Italy, 80131
        • Recruiting
        • Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Oncologia Clinica Sperimentale di Senologia ( Site 1800)
        • Contact:
          • Study Coordinator
          • Phone Number: +3908117770442
    • Catania
      • Misterbianco, Catania, Italy, 95045
        • Recruiting
        • Humanitas Istituto Clinico Catanese ( Site 1811)
        • Contact:
          • Study Coordinator
          • Phone Number: +39 9573390197
    • Forli-Cesena
      • Meldola (FC), Forli-Cesena, Italy, 47014
        • Recruiting
        • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 1807)
        • Contact:
          • Study Coordinator
          • Phone Number: +39 0543 739100
    • Friuli Venezia Giulia
      • Aviano, Friuli Venezia Giulia, Italy, 33081
        • Recruiting
        • CRO-IRCCS ( Site 1808)
        • Contact:
          • Study Coordinator
          • Phone Number: +39 0434659253
    • Lazio
      • Rome, Lazio, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1802)
        • Contact:
          • Study Coordinator
          • Phone Number: +390630158545
    • Lombardy
      • Brescia, Lombardy, Italy, 25123
        • Recruiting
        • Azienda Ospedaliera Spedali Civili di Brescia ( Site 1812)
        • Contact:
          • Study Coordinator
          • Phone Number: +390303996536
      • Milan, Lombardy, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1801)
        • Contact:
          • Study Coordinator
          • Phone Number: +390223902597
      • Milan, Lombardy, Italy, 20141
        • Recruiting
        • Istituto Europeo di Oncologia IRCCS-Divisione di Senologia Medica ( Site 1809)
        • Contact:
          • Study Coordinator
          • Phone Number: 02 57489970
      • Monza, Lombardy, Italy, 20900
        • Recruiting
        • Fondazione IRCCS San Gerardo dei Tintori ( Site 1813)
        • Contact:
          • Study Coordinator
          • Phone Number: +39 0392339037
    • Tuscany
      • Florence, Tuscany, Italy, 50134
        • Recruiting
        • Azienda Ospedaliera Universitaria Careggi ( Site 1805)
        • Contact:
          • Study Coordinator
          • Phone Number: +390057947264
  • Japan
      • Fukushima, Japan, 960-1295
        • Recruiting
        • Fukushima Medical University Hospital ( Site 3401)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-24-547-1111
      • Gifu, Japan, 501-1194
        • Recruiting
        • Gifu University Hospital ( Site 3426)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-58-230-6000
      • Hiroshima, Japan, 730-8518
        • Recruiting
        • Hiroshima City Hiroshima Citizens Hospital ( Site 3418)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-82-221-2291
      • Kagoshima, Japan, 892-0833
        • Recruiting
        • Social medical corporation Hakuaikai Sagara Hospital ( Site 3421)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-99-224-1800
      • Kumamoto, Japan, 860-8556
        • Recruiting
        • Kumamoto University Hospital ( Site 3420)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-96-344-2111
      • Kyoto, Japan, 606-8507
        • Recruiting
        • Kyoto University Hospital ( Site 3415)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-75-751-3111
      • Okayama, Japan, 700-8558
        • Recruiting
        • Okayama University Hospital ( Site 3425)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-86-223-7151
      • Osaka, Japan, 541-8567
        • Recruiting
        • Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 3417)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-6-6945-1181
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 467-8602
        • Recruiting
        • Nagoya City University Hospital ( Site 3414)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-52-858-7215
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East ( Site 3403)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-4-7133-1111
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Recruiting
        • Hokkaido University Hospital ( Site 3400)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-11-716-1161
    • Kanagawa
      • Isehara, Kanagawa, Japan, 259-1193
        • Recruiting
        • Tokai University Hospital ( Site 3413)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-463-93-1121
      • Kawasaki, Kanagawa, Japan, 216-8511
        • Recruiting
        • St. Marianna University Hospital ( Site 3405)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-44-977-8111
      • Sagamihara, Kanagawa, Japan, 252-0375
        • Recruiting
        • Kitasato University Hospital ( Site 3411)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-42-778-8111
      • Yokohama, Kanagawa, Japan, 241-8515
        • Recruiting
        • Kanagawa Cancer Center ( Site 3412)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-45-520-2222
    • Mie-ken
      • Tsu, Mie-ken, Japan, 514-8507
        • Recruiting
        • Mie University Hospital ( Site 3423)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-59-231-5246
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
        • Recruiting
        • Tohoku University Hospital ( Site 3422)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-22-717-7000
    • Osaka
      • Suita, Osaka, Japan, 565-0871
        • Recruiting
        • The University of Osaka Hospital ( Site 3416)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-6-6210-8290
    • Saitama
      • Hidaka, Saitama, Japan, 350-1298
        • Recruiting
        • Saitama Medical University International Medical Center ( Site 3402)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-42-984-4111
    • Tokyo
      • Bunkyo, Tokyo, Japan, 113-8431
        • Recruiting
        • Juntendo University Hospital ( Site 3408)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3813-3111
      • Chūō, Tokyo, Japan, 104-8560
        • Recruiting
        • St.Luke's International Hospital ( Site 3427)
        • Contact:
          • Study Coordinator
          • Phone Number: 03-3541-5151
      • Koto, Tokyo, Japan, 135-8550
        • Recruiting
        • Cancer Institute Hospital of JFCR ( Site 3404)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3520-0111
      • Shinagawa, Tokyo, Japan, 142-8666
        • Recruiting
        • Showa Medical University Hospital ( Site 3406)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3784-8000
      • Shinjuku, Tokyo, Japan, 160-0023
        • Recruiting
        • Tokyo Medical University Hospital ( Site 3407)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3342-6111
      • Shinjuku, Tokyo, Japan, 162-8655
        • Recruiting
        • National Center for Global Health and Medicine ( Site 3409)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3202-7181
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • Recruiting
        • Pantai Hospital Kuala Lumpur ( Site 2801)
        • Contact:
          • Study Coordinator
          • Phone Number: +60327814519
      • Kuala Lumpur, Malaysia, 50450
        • Recruiting
        • Prince Court Medical Centre ( Site 2802)
        • Contact:
          • Study Coordinator
          • Phone Number: +60321600000
  • Mexico
    • Mexico City
      • Mexico City, Mexico City, Mexico, 03100
        • Recruiting
        • CENEIT Oncologicos ( Site 0706)
        • Contact:
          • Study Coordinator
          • Phone Number: 5514817472
      • Mexico City, Mexico City, Mexico, 03100
        • Recruiting
        • Health Pharma Professional Research S.A. de C.V: ( Site 0709)
        • Contact:
          • Study Coordinator
          • Phone Number: +525575864856
      • Mexico City, Mexico City, Mexico, 04700
        • Recruiting
        • COI Centro Oncologico Internacional S.A.P.I. de C.V. ( Site 0712)
        • Contact:
          • Study Coordinator
          • Phone Number: +528008773264
      • Mexico City, Mexico City, Mexico, 03100
        • Recruiting
        • Grupo Médico ASSET ( Site 0705)
        • Contact:
          • Study Coordinator
          • Phone Number: 5516217417
    • Nuevo León
      • San Pedro Garza García, Nuevo León, Mexico, 66220
        • Recruiting
        • Oncare - Unidad Valle ( Site 0713)
        • Contact:
          • Study Coordinator
          • Phone Number: +528182188555
      • San Pedro Garza García, Nuevo León, Mexico, 66278
        • Recruiting
        • CENTRO MEDICO ZAMBRANO HELLION ( Site 0711)
        • Contact:
          • Study Coordinator
          • Phone Number: +528188880000
  • Norway
      • Oslo, Norway, 0379
        • Recruiting
        • Oslo universitetssykehus, Radiumhospitalet ( Site 2002)
        • Contact:
          • Study Coordinator
          • Phone Number: +4722934000
    • Buskerud
      • Drammen, Buskerud, Norway, 3004
        • Recruiting
        • Drammen Sykehus, Vestre Viken HF ( Site 2001)
        • Contact:
          • Study Coordinator
          • Phone Number: +4732803000
    • Rogaland
      • Stavanger, Rogaland, Norway, 4011
        • Recruiting
        • Stavanger Universitetssykehus ( Site 2004)
        • Contact:
          • Study Coordinator
          • Phone Number: +4751518000
  • Poland
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-796
        • Recruiting
        • Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2102)
        • Contact:
          • Study Coordinator
          • Phone Number: +48523743029
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 31-115
        • Recruiting
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Oddzial w Krakowie ( Site 2120)
        • Contact:
          • Study Coordinator
          • Phone Number: +48225462758
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-781
        • Recruiting
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Piersi i Chirurgii ( Site 2100)
        • Contact:
          • Study Coordinator
          • Phone Number: +48225462486
      • Wieliszew, Masovian Voivodeship, Poland, 05-135
        • Recruiting
        • Mazowiecki Szpital Onkologiczny-BREAST CANCER ( Site 2101)
        • Contact:
          • Study Coordinator
          • Phone Number: +48227661501
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-027
        • Completed
        • Bialostockie Centrum Onkologii ( Site 2105)
    • Pomeranian Voivodeship
      • Gdynia, Pomeranian Voivodeship, Poland, 81-519
        • Recruiting
        • Szpitale Pomorskie Sp. z o. o.-Oddział Onkologii Klinicznej ( Site 2113)
        • Contact:
          • Study Coordinator
          • Phone Number: +48587260105
    • Silesian Voivodeship
      • Gliwice, Silesian Voivodeship, Poland, 44-102
        • Recruiting
        • Narodowy Instytut Onkologii - Oddzial w Gliwicach-Centrum Diagnostyki i Leczenia Chorob Piersi ( Site 2110)
        • Contact:
          • Study Coordinator
          • Phone Number: +48322788721
    • West Pomeranian Voivodeship
      • Szczecin, West Pomeranian Voivodeship, Poland, 71-730
        • Recruiting
        • Zachodniopomorskie Centrum Onkologii ( Site 2108)
        • Contact:
          • Study Coordinator
          • Phone Number: +48914251544
    • Świętokrzyskie Voivodeship
      • Kielce, Świętokrzyskie Voivodeship, Poland, 25-734
        • Recruiting
        • Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Onkologii Klinicznej, Dzial Ch ( Site 2118)
        • Contact:
          • Study Coordinator
          • Phone Number: +48885997850
  • Portugal
      • Lisbon, Portugal, 1649-035
        • Recruiting
        • Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 2201)
        • Contact:
          • Study Coordinator
          • Phone Number: 00351217805000
      • Lisbon, Portugal, 1400-038
        • Recruiting
        • Fundacao Champalimaud ( Site 2200)
        • Contact:
          • Study Coordinator
          • Phone Number: 00351210480200
      • Porto, Portugal, 4200-072
        • Recruiting
        • Instituto Portugues de Oncologia do Porto ( Site 2202)
        • Contact:
          • Study Coordinator
          • Phone Number: 00351225084000
    • Lisbon District
      • Amadora, Lisbon District, Portugal, 2720-276
        • Recruiting
        • Unidade Local de Saude Amadora/Sintra - Hospital Prof Dr Fernando Fonseca ( Site 2203)
        • Contact:
          • Study Coordinator
          • Phone Number: 00351214348200
  • Singapore
    • Central Singapore
      • Singapore, Central Singapore, Singapore, 168583
        • Recruiting
        • National Cancer Centre Singapore-Medical Oncology ( Site 3002)
        • Contact:
          • Study Coordinator
          • Phone Number: +6564368000
  • South Korea
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital-Internal Medicine ( Site 3102)
        • Contact:
          • Study Coordinator
          • Phone Number: +82-2-2072-0850
      • Seoul, South Korea, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System-Medical oncology ( Site 3100)
        • Contact:
          • Study Coordinator
          • Phone Number: +82-2-2228-8135
      • Seoul, South Korea, 05505
        • Recruiting
        • Asan Medical Center-Department of Oncology ( Site 3103)
        • Contact:
          • Study Coordinator
          • Phone Number: +8-2-3010-3216
      • Seoul, South Korea, 06273
        • Recruiting
        • Gangnam Severance Hospital, Yonsei University Health System-Medical Oncology, Internal Medicine ( Site 3104)
        • Contact:
          • Study Coordinator
          • Phone Number: +82-2-2019-3379
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center-Division of Hematology/Oncology ( Site 3101)
        • Contact:
          • Study Coordinator
          • Phone Number: +82-2-3410-6488
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron-Oncology ( Site 2300)
        • Contact:
          • Study Coordinator
          • Phone Number: +34932746000/ 4691
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital Beata María Ana-oncology ( Site 2309)
        • Contact:
          • Study Coordinator
          • Phone Number: +34914097423
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clinico San Carlos-Oncology Department ( Site 2306)
        • Contact:
          • Study Coordinator
          • Phone Number: 34 913303000x7768
      • Valencia, Spain, 46010
        • Recruiting
        • HOSPITAL CLINICO DE VALENCIA-Oncology ( Site 2302)
        • Contact:
          • Study Coordinator
          • Phone Number: +34961973583
    • Andalusia
      • Seville, Andalusia, Spain, 41013
        • Recruiting
        • HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 2304)
        • Contact:
          • Study Coordinator
          • Phone Number: 34955013068
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
        • Recruiting
        • Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2305)
        • Contact:
          • Study Coordinator
          • Phone Number: +34 93 260 77 44
    • La Coruna
      • A Coruña, La Coruna, Spain, 15006
        • Recruiting
        • CHUAC-Hospital Teresa Herrera-MEDICAL ONCOLOGY ( Site 2307)
        • Contact:
          • Study Coordinator
          • Phone Number: +34981178000
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2301)
        • Contact:
          • Study Coordinator
          • Phone Number: +34913368263
      • Majadahonda, Madrid, Comunidad de, Spain, 28222
        • Recruiting
        • HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA-Medical Oncology ( Site 2308)
        • Contact:
          • Study Coordinator
          • Phone Number: +34911917358
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46009
        • Recruiting
        • Fundación Instituto Valenciano de Oncología-Oncologico ( Site 2303)
        • Contact:
          • Study Coordinator
          • Phone Number: +93663224875
  • Sweden
    • Gävleborg County
      • Gävle, Gävleborg County, Sweden, 801 87
        • Recruiting
        • Gävle sjukhus ( Site 3504)
        • Contact:
          • Study Coordinator
          • Phone Number: +4626154000
    • Stockholm County
      • Stockholm, Stockholm County, Sweden, 171 76
        • Recruiting
        • Karolinska Universitetssjukhuset Solna ( Site 3500)
        • Contact:
          • Study Coordinator
          • Phone Number: +46851770000
      • Stockholm, Stockholm County, Sweden, 112 81
        • Recruiting
        • Capio St. Gorans Sjukhus ( Site 3503)
        • Contact:
          • Study Coordinator
          • Phone Number: +46858701000
    • Uppsala County
      • Uppsala, Uppsala County, Sweden, 751 85
        • Recruiting
        • Akademiska Sjukhuset ( Site 3501)
        • Contact:
          • Study Coordinator
          • Phone Number: +46186110000
    • Västra Götaland County
      • Borås, Västra Götaland County, Sweden, 501 82
        • Recruiting
        • Södra Älvsborg Sjukhus ( Site 3502)
        • Contact:
          • Study Coordinator
          • Phone Number: +46336161000
      • Gothenburg, Västra Götaland County, Sweden, 413 45
        • Recruiting
        • Sahlgrenska Universitetssjukhuset. ( Site 3505)
        • Contact:
          • Study Coordinator
          • Phone Number: +46313428503
  • Switzerland
      • Fribourg, Switzerland, 1708
        • Recruiting
        • HFR Fribourg - Hôpital Cantonal ( Site 2402)
        • Contact:
          • Study Coordinator
          • Phone Number: +41263062260
    • Canton of Bern
      • Thun, Canton of Bern, Switzerland, 3600
        • Recruiting
        • Spital Thun ( Site 2400)
        • Contact:
          • Study Coordinator
          • Phone Number: +41 58 636 22 27
    • Canton of Geneva
      • Geneva, Canton of Geneva, Switzerland, 1206
        • Recruiting
        • Clinique Générale-Beaulieu ( Site 2406)
        • Contact:
          • Study Coordinator
          • Phone Number: +41228395798
    • Canton of Zurich
      • Zurich, Canton of Zurich, Switzerland, 8008
        • Recruiting
        • Brust-Zentrum ( Site 2401)
        • Contact:
          • Study Coordinator
          • Phone Number: +41445338141
    • Kanton Graubünden
      • Chur, Kanton Graubünden, Switzerland, 7000
        • Completed
        • Kantonsspital Graubünden-Medizin ( Site 2404)
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01140
        • Recruiting
        • Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 2501)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 322 459 2222
      • Ankara, Turkey (Türkiye), 06200
        • Recruiting
        • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi-oncology ( Site 2504)
        • Contact:
          • Study Coordinator
          • Phone Number: 03123360909
      • Ankara, Turkey (Türkiye), 06520
        • Recruiting
        • Memorial Ankara Hastanesi-Medical Oncology ( Site 2502)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 312 253 6666
      • Istanbul, Turkey (Türkiye), 34214
        • Recruiting
        • Medipol Mega Universite Hastanesi-oncology ( Site 2503)
        • Contact:
          • Study Coordinator
          • Phone Number: 444 70 44 - 17067
      • Samsun, Turkey (Türkiye), 55200
        • Recruiting
        • Samsun Medical Park Hastanesi-medical oncology ( Site 2500)
        • Contact:
          • Study Coordinator
          • Phone Number: 03623114040
  • United Kingdom
      • Leeds, United Kingdom, LS9 7TF
        • Recruiting
        • St James's University Hospital-Leeds Cancer Centre ( Site 2608)
        • Contact:
          • Study Coordinator
          • Phone Number: 0113 243 3144
    • Bristol, City of
      • Bristol, Bristol, City of, United Kingdom, BS2 8ED
        • Recruiting
        • University Hospitals Bristol NHS Foundation Trust ( Site 2601)
        • Contact:
          • Study Coordinator
          • Phone Number: 441173426733
    • England
      • Truro, England, United Kingdom, TR1 3LJ
        • Recruiting
        • The Royal Cornwall Hospital ( Site 2603)
        • Contact:
          • Study Coordinator
          • Phone Number: 01872258345
    • London, City of
      • London, London, City of, United Kingdom, EC1A 7BE
        • Recruiting
        • St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 2602)
        • Contact:
          • Study Coordinator
          • Phone Number: +44 20 7377 7000
      • London, London, City of, United Kingdom, NW1 2PG
        • Recruiting
        • University College London Hospital ( Site 2604)
        • Contact:
          • Study Coordinator
          • Phone Number: +44 20 3456 7890
    • Midlothian
      • Edinburgh, Midlothian, United Kingdom, EH4 2XU
        • Recruiting
        • Western General Hospital ( Site 2607)
        • Contact:
          • Study Coordinator
          • Phone Number: 0300 123 1600
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36607
        • Recruiting
        • Infirmary Cancer Care ( Site 0001)
        • Contact:
          • Study Coordinator
          • Phone Number: 251-435-2273
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Recruiting
        • Ironwood Cancer & Research Centers-Research ( Site 0054)
        • Contact:
          • Study Coordinator
          • Phone Number: 480-821-2838
    • California
      • Fountain Valley, California, United States, 92708
        • Recruiting
        • MemorialCare Orange Coast Medical Center ( Site 9501)
        • Contact:
          • Study Coordinator
          • Phone Number: 714-378-7000
      • La Jolla, California, United States, 92037
        • Recruiting
        • Scripps Cancer Center ( Site 0052)
        • Contact:
          • Study Coordinator
          • Phone Number: 800-727-4777
      • Los Alamitos, California, United States, 90720
        • Completed
        • Cancer and Blood Specialty Clinic ( Site 0008)
      • Oakland, California, United States, 94611
        • Recruiting
        • Kaiser Permanente - Oakland ( Site 0079)
        • Contact:
          • Study Coordinator
          • Phone Number: 877-642-4691
      • Oceanside, California, United States, 92056
        • Recruiting
        • Profound Research LLC ( Site 0105)
        • Contact:
          • Study Coordinator
          • Phone Number: 760-826-2020
      • Roseville, California, United States, 95661
        • Recruiting
        • Kaiser Permanente - Roseville ( Site 0081)
        • Contact:
          • Study Coordinator
          • Phone Number: 877-642-4691
      • San Francisco, California, United States, 94115
        • Recruiting
        • Kaiser Permanente - San Francisco ( Site 0080)
        • Contact:
          • Study Coordinator
          • Phone Number: 877-642-4691
      • Santa Clara, California, United States, 95051
        • Recruiting
        • Kaiser Permanente - Santa Clara ( Site 0082)
        • Contact:
          • Study Coordinator
          • Phone Number: 877-642-4691
      • Santa Rosa, California, United States, 95403
        • Recruiting
        • Providence Medical Foundation ( Site 9543)
        • Contact:
          • Study Coordinator
          • Phone Number: 707-528-1050
      • Vallejo, California, United States, 94589
        • Recruiting
        • Kaiser Permanente Vallejo Medical Center ( Site 0060)
        • Contact:
          • Study Coordinator
          • Phone Number: 877-642-4691
      • Walnut Creek, California, United States, 94596
        • Recruiting
        • Kaiser Permanente - Walnut Creek ( Site 0078)
        • Contact:
          • Study Coordinator
          • Phone Number: 877-642-4691
      • Walnut Creek, California, United States, 94598
        • Completed
        • Bass Medical Group ( Site 0089)
    • Colorado
      • Grand Junction, Colorado, United States, 81501
        • Recruiting
        • Cancer Centers of Colorado St. Mary's Regional Hospital ( Site 0046)
        • Contact:
          • Study Coordinator
          • Phone Number: 970-298-7500
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale Cancer Center ( Site 0053)
        • Contact:
          • Study Coordinator
          • Phone Number: 203-688-4242
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • Recruiting
        • AdventHealth Altamonte Springs ( Site 0125)
        • Contact:
          • Study Coordinator
          • Phone Number: 407-834-5151
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Orlando Health Cancer Institute ( Site 0030)
        • Contact:
          • Study Coordinator
          • Phone Number: 321-843-8370
      • St. Petersburg, Florida, United States, 33709
        • Recruiting
        • Comprehensive Hematology Oncology ( Site 0091)
        • Contact:
          • Study Coordinator
          • Phone Number: 727-344-6569
      • Stuart, Florida, United States, 34994
        • Recruiting
        • Cleveland Clinic Martin North Hospital ( Site 0114)
        • Contact:
          • Study Coordinator
          • Phone Number: 772-419-2146
    • Georgia
      • Thomasville, Georgia, United States, 31792
        • Completed
        • Archbold Memorial Hospital-Lewis Hall Singletary Oncology Center ( Site 0040)
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Recruiting
        • Illinois Cancer Specialists (ICS) ( Site 8010)
        • Contact:
          • Study Coordinator
          • Phone Number: 847-259-4482
      • Skokie, Illinois, United States, 60077
        • Recruiting
        • Orchard Healthcare Research Inc. ( Site 0014)
        • Contact:
          • Study Coordinator
          • Phone Number: 224-534-7580
    • Indiana
      • Dyer, Indiana, United States, 46311
        • Recruiting
        • Northwest Cancer Center - Dyer Clinic ( Site 0097)
        • Contact:
          • Study Coordinator
          • Phone Number: 615-785-5914
      • Fort Wayne, Indiana, United States, 46845
        • Recruiting
        • Parkview Research Center at Parkview Regional Medical Center ( Site 0011)
        • Contact:
          • Study Coordinator
          • Phone Number: 260-266-6313
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Completed
        • Cancer Center of Kansas ( Site 0004)
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Recruiting
        • Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0044)
        • Contact:
          • Study Coordinator
          • Phone Number: 859-301-4000
    • Louisiana
      • Alexandria, Louisiana, United States, 71301
        • Recruiting
        • CHRISTUS St. Frances Cabrini Hospital Center for Cancer Care ( Site 0109)
        • Contact:
          • Study Coordinator
          • Phone Number: 318-528-6976
      • Monroe, Louisiana, United States, 71202
        • Completed
        • Ochsner LSU Health - Monroe Medical Center, Family Medicine Clinic ( Site 0063)
      • Shreveport, Louisiana, United States, 71103
        • Recruiting
        • Louisiana State University Health Sciences Shreveport ( Site 0029)
        • Contact:
          • Study Coordinator
          • Phone Number: 318-813-1429
    • Maryland
      • Silver Spring, Maryland, United States, 20910
        • Recruiting
        • Holy Cross Hospital ( Site 0069)
        • Contact:
          • Study Coordinator
          • Phone Number: 301-754-7552
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan ( Site 0103)
        • Contact:
          • Study Coordinator
          • Phone Number: 800-865-1125
      • Royal Oak, Michigan, United States, 48073
        • Completed
        • Profound Research LLC ( Site 0074)
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55426
        • Recruiting
        • Metro-Minnesota Community Clinical Oncology ( Site 0031)
        • Contact:
          • Study Coordinator
          • Phone Number: 952-993-3252
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Recruiting
        • University of Mississippi Medical Center ( Site 0043)
        • Contact:
          • Study Coordinator
          • Phone Number: 601-984-5590
    • Missouri
      • Fenton, Missouri, United States, 63026
        • Completed
        • SSM Health Cancer Care - Fenton ( Site 0088)
      • Osage Beach, Missouri, United States, 65065
        • Recruiting
        • Lake Regional Hospital ( Site 0009)
        • Contact:
          • Study Coordinator
          • Phone Number: 573-302-2772
      • St Louis, Missouri, United States, 63108
        • Recruiting
        • Siteman Cancer Center ( Site 0099)
        • Contact:
          • Study Coordinator
          • Phone Number: 314-362-0263
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Recruiting
        • Optum Care Cancer Center ( Site 9535)
        • Contact:
          • Study Coordinator
          • Phone Number: 702-724-8787
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Recruiting
        • New Mexico Oncology Hematology Consultants Ltd. ( Site 0090)
        • Contact:
          • Study Coordinator
          • Phone Number: 505-842-8171
      • Santa Fe, New Mexico, United States, 87505
        • Recruiting
        • CHRISTUS St. Vincent Regional Cancer Center ( Site 0118)
        • Contact:
          • Study Coordinator
          • Phone Number: 505-913-8953
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai ( Site 0123)
        • Contact:
          • Study Coordinator
          • Phone Number: 212-241-3300
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center ( Site 0067)
        • Contact:
          • Study Coordinator
          • Phone Number: 212-639-2000
      • Westbury, New York, United States, 11590
        • Recruiting
        • Clinical Research Alliance ( Site 0086)
        • Contact:
          • Study Coordinator
          • Phone Number: 516-734-8906
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Levine Cancer Institute ( Site 0083)
        • Contact:
          • Study Coordinator
          • Phone Number: 980-442-3130
      • Fayetteville, North Carolina, United States, 28304
        • Recruiting
        • Cape Fear Valley Health System ( Site 0136)
        • Contact:
          • Study Coordinator
          • Phone Number: 472-210-8847
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Recruiting
        • Sanford Cancer Center Bismarck ( Site 0058)
        • Contact:
          • Study Coordinator
          • Phone Number: 701-323-5741
      • Fargo, North Dakota, United States, 58102
        • Recruiting
        • Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0056)
        • Contact:
          • Study Coordinator
          • Phone Number: 701-234-2000
      • Grand Forks, North Dakota, United States, 58201
        • Recruiting
        • Altru Cancer Center ( Site 0104)
        • Contact:
          • Study Coordinator
          • Phone Number: 701-780-5451
    • Ohio
      • Canton, Ohio, United States, 44708
        • Recruiting
        • Cleveland Clinic - Mercy Hospital ( Site 0057)
        • Contact:
          • Study Coordinator
          • Phone Number: 330-489-1274
      • Massillon, Ohio, United States, 44646
        • Recruiting
        • Tri-County Hematology & Oncology Associates, Inc. ( Site 0076)
        • Contact:
          • Study Coordinator
          • Phone Number: 330-478-0001
      • Maumee, Ohio, United States, 43537
        • Recruiting
        • Taylor Cancer Research Center ( Site 9500)
        • Contact:
          • Study Coordinator
          • Phone Number: 567-402-4501
      • Zanesville, Ohio, United States, 43701
        • Recruiting
        • Genesis Healthcare System ( Site 0025)
        • Contact:
          • Study Coordinator
          • Phone Number: 740-454-5271
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73102
        • Recruiting
        • Hightower Clinical, LLC ( Site 0085)
        • Contact:
          • Study Coordinator
          • Phone Number: 405-479-8331
      • Tulsa, Oklahoma, United States, 74146
        • Recruiting
        • Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0041)
        • Contact:
          • Study Coordinator
          • Phone Number: 918-505-3200
    • Oregon
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center ( Site 0116)
        • Contact:
          • Study Coordinator
          • Phone Number: 503-215-1979
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence Oncology and Hematology Care Clinic - Westside ( Site 0126)
        • Contact:
          • Study Coordinator
          • Phone Number: 503-215-1979
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Sidney Kimmel Cancer Center at Jefferson ( Site 0049)
        • Contact:
          • Study Coordinator
          • Phone Number: 215-955-8874
      • York, Pennsylvania, United States, 17403
        • Recruiting
        • Cancer Care Associates Of York ( Site 9517)
        • Contact:
          • Study Coordinator
          • Phone Number: 717-741-9229
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Recruiting
        • Sanford Cancer Center ( Site 0059)
        • Contact:
          • Study Coordinator
          • Phone Number: 605-328-8000
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Recruiting
        • West Cancer Center and Research Institute ( Site 0084)
        • Contact:
          • Study Coordinator
          • Phone Number: 901-683-0055
      • Memphis, Tennessee, United States, 38120
        • Recruiting
        • Baptist Cancer Center ( Site 0101)
        • Contact:
          • Study Coordinator
          • Phone Number: 901-226-3077
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • SCRI Oncology Partners ( Site 7000)
        • Contact:
          • Study Coordinator
          • Phone Number: 615-329-7274
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • One Oncology - Tennessee Oncology ( Site 0098)
        • Contact:
          • Study Coordinator
          • Phone Number: 615-986-4350
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Tennessee Oncology ( Site 0111)
        • Contact:
          • Study Coordinator
          • Phone Number: 615-986-4350
      • Nashville, Tennessee, United States, 37212
        • Recruiting
        • Vanderbilt Health One Hundred Oaks ( Site 0042)
        • Contact:
          • Study Coordinator
          • Phone Number: 800-811-8480
      • Nashville, Tennessee, United States, 37208
        • Completed
        • Nashville General Hospital ( Site 0072)
    • Texas
      • Abilene, Texas, United States, 79601
        • Recruiting
        • Hendrick Medical Center ( Site 0117)
        • Contact:
          • Study Coordinator
          • Phone Number: 325-670-2000
      • Amarillo, Texas, United States, 79106
        • Recruiting
        • Harrington Cancer Center ( Site 0061)
        • Contact:
          • Study Coordinator
          • Phone Number: 806-359-4673
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Texas Oncology - DFW ( Site 8000)
        • Contact:
          • Study Coordinator
          • Phone Number: 214-370-1000
      • Dallas, Texas, United States, 75390
        • Recruiting
        • Parkland Health & Hospital System ( Site 0096)
        • Contact:
          • Study Coordinator
          • Phone Number: 214-645-4673
      • Dallas, Texas, United States, 75390
        • Recruiting
        • University of Texas Southwestern Medical Center ( Site 0032)
        • Contact:
          • Study Coordinator
          • Phone Number: 214-645-4673
      • Flower Mound, Texas, United States, 75028
        • Recruiting
        • Texas Oncology - Northeast Texas ( Site 8005)
        • Contact:
          • Study Coordinator
          • Phone Number: 972-537-4100
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • John Peter Smith Hospital ( Site 0106)
        • Contact:
          • Study Coordinator
          • Phone Number: 817-702-8049
      • Houston, Texas, United States, 77030
        • Recruiting
        • Oncology Consultants P.A. ( Site 0107)
        • Contact:
          • Study Coordinator
          • Phone Number: 713-600-0900
      • Laredo, Texas, United States, 78041
        • Recruiting
        • Laguna Clinical Research Associates LLC ( Site 0068)
        • Contact:
          • Study Coordinator
          • Phone Number: 956-724-8543
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Mays Cancer Center ( Site 0122)
        • Contact:
          • Study Coordinator
          • Phone Number: 210-450-1000
      • Tyler, Texas, United States, 75701
        • Recruiting
        • The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0055)
        • Contact:
          • Study Coordinator
          • Phone Number: 903-592-6152
      • Webster, Texas, United States, 77598
        • Recruiting
        • Texas Oncology - Gulf Coast ( Site 8009)
        • Contact:
          • Study Coordinator
          • Phone Number: 281-332-7505
    • Utah
      • Murray, Utah, United States, 84107
        • Recruiting
        • Intermountain Medical Center ( Site 0113)
        • Contact:
          • Study Coordinator
          • Phone Number: 801-507-3630
    • Virginia
      • Fredericksburg, Virginia, United States, 22408
        • Recruiting
        • Hematology Oncology Associates of Fredericksburg ( Site 9550)
        • Contact:
          • Study Coordinator
          • Phone Number: 540-371-0079
      • Fredericksburg, Virginia, United States, 22405
        • Recruiting
        • Mary Washington Hospital ( Site 0129)
        • Contact:
          • Study Coordinator
          • Phone Number: 540-300-6182
      • Midlothian, Virginia, United States, 23114
        • Recruiting
        • Bon Secours Memorial Regional Medical Center-Oncology Research Department ( Site 0020)
        • Contact:
          • Study Coordinator
          • Phone Number: 804-893-8717
      • Norfolk, Virginia, United States, 23502
        • Recruiting
        • Virginia Oncology Associates (VOA) ( Site 8008)
        • Contact:
          • Study Coordinator
          • Phone Number: 646-694-8125
      • Richmond, Virginia, United States, 23229
        • Recruiting
        • Virginia Cancer Institute ( Site 0034)
        • Contact:
          • Study Coordinator
          • Phone Number: 804-287-3000
    • Washington
      • Tacoma, Washington, United States, 98405
        • Recruiting
        • Northwest Medical Specialties, PLLC ( Site 0093)
        • Contact:
          • Study Coordinator
          • Phone Number: 253-428-8700
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
        • Recruiting
        • SSM Health Dean Medical Group ( Site 0087)
        • Contact:
          • Study Coordinator
          • Phone Number: 516-488-2918

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Has centrally confirmed TNBC, as defined by the most recent American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines
  • Has no evidence of locoregional or distant relapse, as assessed by the treating physician
  • Had neoadjuvant treatment based on the KEYNOTE-522 regimen (pembrolizumab with carboplatin/taxanes and pembrolizumab with anthracycline-based chemotherapy) followed by surgery according to National Comprehensive Cancer Network (NCCN) treatment guidelines for TNBC
  • Had adequate excision and surgical removal of all clinically evident disease in the breast and/or lymph nodes and have adequately recovered from surgery
  • Has non-pathologic complete response at surgery
  • Is able to continue on adjuvant pembrolizumab
  • Randomization must be conducted within 16 weeks from surgical resection
  • Completed adjuvant radiation therapy (if indicated) and recovered before randomization
  • Has provided tissue from the surgical resection for central laboratory determination of trophoblast cell surface antigen 2 (TROP2) status
  • If capable of producing sperm, the participant agrees to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention (120 days for sacituzumab tirumotecan and 95 days for capecitabine [no restriction for pembrolizumab]): agrees to refrain from donating sperm AND is either abstinent and agrees to remain abstinent or uses highly effective contraception
  • For females (assigned at birth), is not pregnant or breastfeeding and ≥1 of the following applies: is not a participant of childbearing potential (POCBP) OR is a POCBP and uses highly effective contraception after the last dose of study intervention (210 days for sacituzumab tirumotecan, 120 days for pembrolizumab, and 185 days for capecitabine). Abstains from breastfeeding during the study intervention period and for at least 120 days after study intervention
  • Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline (except alopecia)
  • Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
  • An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before first dose of study treatment
  • Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B birus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization

Exclusion Criteria:

  • Has a known germline breast cancer gene (BRCA) mutation (deleterious or suspected deleterious) and is eligible for adjuvant therapy with olaparib where olaparib is approved and available
  • Has Grade >2 peripheral neuropathy
  • History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
  • Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
  • Has uncontrolled, significant cardiovascular disease or cerebrovascular disease including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to >480 ms, and/or other serious cardiovascular and cerebrovascular diseases within 6 months prior to study intervention
  • Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC) or a topoisomerase I inhibitor-containing ADC
  • Received anticancer therapy in the adjuvant phase including but not limited to chemotherapy, small molecule anticancer drugs, poly (adenosine diphosphate ribose) polymerase (PARP) inhibitors, ADCs, and/or immunotherapy, with the exception of adjuvant radiation therapy
  • Is currently receiving a strong inducer/inhibitor of cytochrome P450 3A4 (CYP3A4) that cannot be discontinued for the duration of the study. The required washout period before starting sacituzumab tirumotecan is 2 weeks
  • Except for pembrolizumab as neoadjuvant therapy for early-stage TNBC: received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein-4 [CTLA-4], OX-40 [cluster of differentiation (CD) 134], or CD137)
  • Except for chemotherapy as neoadjuvant therapy for early-stage TNBC: Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization
  • Received prior radiotherapy within 3 weeks of start of study intervention or required corticosteroids for radiation related toxicities that cannot be discontinued before the first dose of study intervention
  • Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed
  • Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
  • Has known additional malignancy that is progressing or has required active treatment within the past 5 years
  • Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
  • Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
  • Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
  • Has active infection requiring systemic therapy
  • HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Has concurrent active hepatitis B and hepatitis C virus infection
  • Has history of allogeneic tissue/solid organ transplant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment of Physician's Choice
Participants receive pembrolizumab q6w or pembrolizumab q6w in combination with capecitabine (twice daily [BID] on Days 1 to 14 and 22 to 35 every 42 days x 4 [2 weeks 1, 1 week off]) for 24 weeks.
Biological: Pembrolizumab
Pembrolizumab 400 mg intravenous (IV) infusion q6w
Other Names:
  • MK-3475
  • SCH 900475
  • KEYTRUDA®
Drug: Capecitabine
Capecitabine 1000 mg/m^2 to 1250 mg/m^2 by mouth BID
Other Names:
  • XELODA
Experimental: Pembrolizumab + sacituzumab tirumotecan
Participants receive pembrolizumab every 6 weeks (q6w) in combination with sacituzumab tirumotecan every 2 weeks (q2w) for 24 weeks. In addition, participants receive an antihistamine, an H2 antagonist of investigator's choice, acetaminophen (or equivalent), and dexamethasone (or equivalent) per each drug's product label prior to sacituzumab tirumotecan infusions.
Biological: Pembrolizumab
Pembrolizumab 400 mg intravenous (IV) infusion q6w
Other Names:
  • MK-3475
  • SCH 900475
  • KEYTRUDA®
Biological: Sacituzumab tirumotecan
Sacituzumab tirumotecan 4 mg/kg IV infusion q2w
Other Names:
  • MK-2870

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Invasive Disease-Free Survival (iDFS)
Time Frame: Up to ~77 months
iDFS is the time from randomization to invasive local, regional, or distant recurrence, invasive contralateral breast cancer, or death due to any cause, whichever occurs first.
Up to ~77 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to ~101 months
OS is the time from randomization to death due to any cause.
Up to ~101 months
Distant recurrence-free survival (DRFS)
Time Frame: Up to ~101 months
DRFS is the time from randomization to distant recurrence or death due to any cause, whichever occurs first.
Up to ~101 months
Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score
Time Frame: Baseline and up to ~60 months
EORTC QLQ-C30 is a 30-item scale to assess the overall quality of life in cancer patients. The overall functioning score is based on participant responses that are scored on a 7-point scale (1 = "Very poor" to 7 = "Excellent"). Higher scores indicate better overall health status.
Baseline and up to ~60 months
Change from baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score
Time Frame: Baseline and up to ~60 months
EORTC QLQ-C30 is a 30-item scale to assess the overall quality of life of cancer patients. The physical functioning score is based on participant responses to questions that scored on a 4-point scale (1 = 'Not at All' to 4 = 'Very Much'). Higher scores indicate better physical functioning.
Baseline and up to ~60 months
Change from baseline in EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score
Time Frame: Baseline and up to ~60 months
EORTC QLQ-C30 is a 30-item scale to assess the overall quality of life of cancer patients. The role functioning score is based on participant responses to questions that scored on a 4-point scale (1 = 'Not at All' to 4 = 'Very Much'). Higher scores indicate better role functioning.
Baseline and up to ~60 months
Change from baseline in EORTC QLQ-C30 Fatigue (Items 10, 12, and 18) Combined Score
Time Frame: Baseline and up to ~60 months
EORTC QLQ-C30 is a 30-item scale to assess the overall quality of life of cancer patients. Participant responses to questions about their fatigue are scored on a 4-point scale (1 = "Not at All" to 4 = "Very Much"). Lower scores indicate a better level of fatigue.
Baseline and up to ~60 months
Number of participants who experience one or more adverse events (AEs)
Time Frame: Up to ~42 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to ~42 weeks
Number of participants who discontinue study intervention due to an AE
Time Frame: Up to 24 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2024

Primary Completion (Estimated)

December 16, 2030

Study Completion (Estimated)

December 14, 2037

Study Registration Dates

First Submitted

April 26, 2024

First Submitted That Met QC Criteria

April 26, 2024

First Posted (Actual)

May 1, 2024

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2870-012
  • U1111-1289-8264 (Registry Identifier: UTN)
  • jRCT2031240476 (Registry Identifier: Japan Registry of Clinical Trials (jRCT))
  • 2023-504962-52-00 (Registry Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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