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) (ASCENT-05)

April 29, 2026 updated by: Gilead Sciences

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.

Study Overview

Status

Recruiting

Conditions

Triple Negative Breast Cancer

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1514

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

Name: Gilead Clinical Study Information Center
Phone Number: 1-833-445-3230 (GILEAD-0)
Email: GileadClinicalTrials@gilead.com

Study Locations

Australia
- New South Wales
  - Campbelltown, New South Wales, Australia, 2560
    - Recruiting
    - Macarthur Cancer Therapy Centre, Campbelltown Hospital
  - Darlinghurst, New South Wales, Australia, 2010
    - Recruiting
    - Kinghorn Cancer Centre
  - Gateshead, New South Wales, Australia, 2290
    - Recruiting
    - Lake Macquarie Private Hospital
  - Port Macquarie, New South Wales, Australia, 2444
    - Recruiting
    - Port Macquarie Base Hospital
- Queensland
  - Cairns, Queensland, Australia, 4870
    - Recruiting
    - Cairns Hospital
  - Woolloongabba, Queensland, Australia, 4102
    - Recruiting
    - Princess Alexandra Hospital
- South Australia
  - Adelaide, South Australia, Australia, 5000
    - Recruiting
    - Cancer Research SA
- Victoria
  - Bendigo, Victoria, Australia, 3551
    - Recruiting
    - Bendigo Health
  - Clayton, Victoria, Australia, 3168
    - Recruiting
    - Monash Medical Centre
- Western Australia
  - Murdoch, Western Australia, Australia, 6150
    - Recruiting
    - Fiona Stanley Hospital
Belgium
- - Brussels, Belgium, 1160
    - Active, not recruiting
    - Chirec Delta Hospital
  - Leuven, Belgium, 3000
    - Active, not recruiting
    - UZ Leuven
  - Roeselare, Belgium, 8800
    - Active, not recruiting
    - AZ Delta VZW
  - Wilrijk, Belgium, 2610
    - Recruiting
    - Ziekenhuls aan de Stroom vzw (ZAS vzw), ZAS Augustinus
Brazil
- - Brasília, Brazil, 71681-603
    - Recruiting
    - St. de Habitações Individuais Sul QI 15 - Lago Sul, Brasília - DF, Brasil
  - Curitiba, Brazil, 80510-130
    - Recruiting
    - Rua Myltho Anselmo da Silva, 870 - Mercês, Curitiba - PR, CEP 80510-130
  - Itajaí, Brazil, 88300-000
    - Recruiting
    - R. Aderbal Ramos da Silva, 148 - Centro, Itajaí - SC, 88300-000, Brasil
  - Natal, Brazil, 59062-200
    - Recruiting
    - Av. Miguel Castro, 1355, Nossa Senhora de Nazaré, Natal/RN
  - Porto Alegre, Brazil, 90020-090
    - Recruiting
    - Rua Professor Annes Dias, 295 - Centro Histórico, Porto Alegre - RS, , Brasil
  - Porto Alegre, Brazil, 90470-340
    - Recruiting
    - Av. Soledad, 569, sala 1103, Três Figueiras, CEP 90470-340
  - Porto Alegre, Brazil, 90610-000
    - Recruiting
    - Av. Ipiranga 6690
  - Salvador, Brazil, 40170-110
    - Recruiting
    - Av. Milton Santos, 123 - Ondina, Salvador - BA, , Brasil
  - São Paulo, Brazil, 01317-000
    - Recruiting
    - Av. Brigadeiro Luís Antônio 733, loja 8
  - São Paulo, Brazil, 01323-001
    - Recruiting
    - Martiiano de Carvalho 965
  - São Paulo, Brazil, 01509-010
    - Recruiting
    - CIPE Centro Internacional de Pesquisa; A.C. Camargo Cancer Center
  - Teresina, Brazil, 60449-200
    - Recruiting
    - Rua Gardênia, 710, Edifício Prime, 4º andar, Bairro Jóquei, Teresina - PI, CEP 60449-200
France
- - Amiens, France, 80000
    - Recruiting
    - CHU Amiens Picardie
  - Chambray-lès-Tours, France, 37170
    - Recruiting
    - Pôle Santé Léonard De Vinci - ROC37
  - Le Mans, France, 72000
    - Recruiting
    - Clinique Victor Hugo
  - Limoges, France, 87042
    - Recruiting
    - CHU de LImoges
  - Loire Atlantique, France, 44 805
    - Recruiting
    - Institut de Cancérologie de l'Ouest (ICO) - St Herblain
  - Lyon, France, 69008
    - Recruiting
    - Hôpital Privé Jean Mermoz
  - Nancy, France, 54000
    - Recruiting
    - Centre d'oncologie de Gentilly
  - Nantes, France, 44277
    - Recruiting
    - L'Hôpital Privé du Confluent
  - Nîmes, France, 30029
    - Recruiting
    - CHU de Nîmes
  - Plérin, France, 22190
    - Recruiting
    - Hopital Privé des Côtes d'Armor - Centre CARIO-HPCA
  - Poitiers, France, 86021
    - Recruiting
    - CHU de Poitiers, 2 Rue de la Milétrie
  - Rennes, France, 35042
    - Recruiting
    - Centre Eugene Marquis
  - Toulouse, France, 31059
    - Recruiting
    - Oncopole Claudius Regaud - IUCT-O
Germany
- - Augsburg, Germany, 86150
    - Recruiting
    - Hämatologie-Onkologie im Zentrum MVZ GmbH
  - Berlin, Germany, 13125
    - Active, not recruiting
    - Schwanebecker Chaussee 50
  - Berlin, Germany, 13597
    - Recruiting
    - Möllendorffstr. 52, 10367 Berlin 2. Behandlungsstandort: Markt 2-3, 13597 Berlin
  - Bielefeld, Germany, 33604
    - Recruiting
    - Teutoburger Str. 60
  - Bottrop, Germany, 46236
    - Recruiting
    - Josef-Albers-Str.70
  - Braunschweig, Germany, 38100
    - Recruiting
    - Studien GbR Braunschweig
  - Bremen, Germany, 28209
    - Recruiting
    - Hämato-Onkologische Praxis im Medicum
  - Bremen, Germany, 28205
    - Recruiting
    - St.-Juergen-Str. 1
  - Cologne, Germany, 50935
    - Recruiting
    - St. Elisabeth Krankenhaus GmbH
  - Dortmund, Germany, 44137
    - Recruiting
    - St. Johannes Hospital
  - Dresden, Germany, 01307
    - Recruiting
    - Fetscherstraße ,74
  - Düsseldorf, Germany, 40235
    - Recruiting
    - Kostara Gyn. Oncology Clinic Research UG
  - Erlangen, Germany, 91054
    - Recruiting
    - Universitätsstraße, 21-23
  - Essen, Germany, 45136
    - Recruiting
    - Henricistraße 92, 45136 Essen, Germany
  - Esslingen am Neckar, Germany, 73730
    - Recruiting
    - Klinikum Esslingen
  - Frankfurt, Germany, 60431
    - Recruiting
    - Wilhelm-Epstein-Str. 4
  - Frankfurt am Main, Germany, 65929
    - Recruiting
    - Gotenstraße 6-8
  - Freiburg im Breisgau, Germany, 79106
    - Recruiting
    - Hugstetter Str. 55
  - Gelsenkirchen, Germany, 45879
    - Recruiting
    - Munckelstrasse 27
  - Georgsmarienhütte, Germany, 49124
    - Recruiting
    - MVZ Ⅱ der Niels Stensen Kliniken
  - Gera, Germany, 7548
    - Recruiting
    - Straße des Friedens 122
  - Hamburg, Germany, 20357
    - Recruiting
    - Moorkamp 2-6
  - Hamburg, Germany, 20259
    - Recruiting
    - Hohe Weide 17b
  - Jena, Germany, 07447
    - Recruiting
    - Am Klinikum 1
  - Karlsruhe, Germany, 76137
    - Active, not recruiting
    - Edgar-von-Gierke-Straße 2
  - Kassel, Germany, 34117
    - Recruiting
    - Elisabeth Krankenhaus Brustzentrum
  - Kiel, Germany, 24105
    - Recruiting
    - Arnold-Heller-Str. 3 Haus C
  - Koblenz, Germany, 56068
    - Recruiting
    - InVO - Institut für Versorgungsforschung in der Onkologie GbR / Praxis für Hämatologie und Onkologie
  - Langen, Germany, 63225
    - Recruiting
    - Fachärztezentrum Langen
  - Leipzig, Germany, 4277
    - Recruiting
    - Biedermannstrasse 84
  - Leipzig, Germany, 04103
    - Recruiting
    - Liebigstraße 20
  - Mannheim, Germany, 68167
    - Recruiting
    - Universitätsklinikum Mannheim
  - Munich, Germany, 80637
    - Recruiting
    - Taxisstrasse 3
  - Mühlhausen, Germany, 99974
    - Not yet recruiting
    - Bei der Marienkirche 6
  - Münster, Germany, 48149
    - Recruiting
    - Albert-Schweitzer-Campus 1, Building A1,
  - Offenbach, Germany, 63069
    - Recruiting
    - Starkenburgring 66, 63069 Offenbach
  - Paderborn, Germany, 33098
    - Recruiting
    - Husenerstr. 81
  - Potsdam, Germany, 14467
    - Recruiting
    - Charlottenstraße 72
  - Ravensburg, Germany, 88212
    - Recruiting
    - Elisabethenstr. 19, 88212 Ravensburg
  - Rostock, Germany, 18059
    - Recruiting
    - Südring 81
  - Stade, Germany, 21680
    - Active, not recruiting
    - Harsefelderstraße 8
  - Stuttgart, Germany, 70199
    - Active, not recruiting
    - Böheimstr. 37
  - Traunstrein, Germany, 83278
    - Recruiting
    - Schierghoferstrasse 1
  - Tübingen, Germany, 72076
    - Recruiting
    - Calwerstrasse 7
  - Ulm, Germany, 89075
    - Recruiting
    - Prittwitzstr. 43
  - Wiesbaden, Germany, 65189
    - Recruiting
    - Beethovenstrasse 20
  - Worms, Germany, 67550
    - Recruiting
    - Klinikum Worms Frauenklinik
  - Wuppertal, Germany, 42283
    - Recruiting
    - Helios University Hospital University Witten/Herdecke
Ireland
- - Dublin, Ireland, D07 R2WY
    - Not yet recruiting
    - Mater Misericordiae University Hospital
  - Dublin, Ireland, D08NH41
    - Recruiting
    - St James's Hospital
  - Dublin, Ireland, D09V2N0
    - Not yet recruiting
    - Beaumont Hospital
  - Limerick, Ireland, V94 F858
    - Not yet recruiting
    - University Hospital Limerick
  - Wilton, Ireland, T12 DC4A
    - Active, not recruiting
    - Cork University Hospital
Italy
- - Bari, Italy, 70124
    - Recruiting
    - IRCCS Istituto Tumori "Giovanni Paolo II"
  - Bologna, Italy, 40138
    - Active, not recruiting
    - IRCCS Azienda Ospedaliero-Universitaria di Bologna
  - Florence, Italy, 50134
    - Active, not recruiting
    - Azienda Ospedaliera Universitaria Careggi
  - Misterbianco, Italy, 95125
    - Recruiting
    - Humanitas Istituto Clinico Catanese
  - Modena, Italy, 41125
    - Active, not recruiting
    - AOU Modena
  - Naples, Italy, 80131
    - Recruiting
    - IRCCS Fondazione G. Pascale
  - Parma, Italy, 43100
    - Recruiting
    - Istituto Romagnolo Per Lo Studio Dei Tumori (IRST) 'Dino Amadori? IRCCS
  - Roma, Italy, 168
    - Active, not recruiting
    - Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  - Rome, Italy, 00128
    - Active, not recruiting
    - Fondazione Policlinico Universitario Campus Bio-Medico di Roma
  - Torino, Italy, 10123
    - Active, not recruiting
    - AOU Città della salute e della scienza di Torino
  - Trento, Italy, 38122
    - Recruiting
    - Ospedale Santa Chiara
South Korea
- - Chungcheongnam-do, South Korea, 31151
    - Recruiting
    - Soonchunhyang University Cheonan Hospital
  - Daegu, South Korea, 41404
    - Recruiting
    - Kyungpook National University Chilgok Hospital
  - Gyeonggi-do, South Korea, 13620
    - Recruiting
    - Seoul National University Bundang Hospital
  - Seodaemun-gu, South Korea, 3722
    - Recruiting
    - Severance Hospital
  - Seoul, South Korea, 05505
    - Recruiting
    - Asan Medical Center
  - Seoul, South Korea, 02841
    - Recruiting
    - Korea University Anam Hospital
  - Seoul, South Korea, 6351
    - Recruiting
    - Samsung Medical Center
  - Seoul, South Korea
    - Recruiting
    - The Catholic University of Korea, Seoul St. Mary's Hospital
  - Seoul, South Korea, 06273
    - Recruiting
    - Gangnam Severance Hospital
  - Seoul, South Korea, 3080
    - Recruiting
    - Seoul National University Hospital
Spain
- - A Coruña, Spain, 15006
    - Recruiting
    - Medical Oncology Unit. A Coruña University Hospital
  - Badalona, Spain, 08916
    - Recruiting
    - ICO Badalona - Hospital Germans Trias i Pujol
  - Barakaldo, Spain, 48903
    - Recruiting
    - Hospital Universitary of Cruces
  - Barcelona, Spain, 08036
    - Recruiting
    - Hospital Clinic de Barcelona
  - Barcelona, Spain, 8003
    - Recruiting
    - Hospital del Mar
  - Barcelona, Spain, 8041
    - Recruiting
    - Hospital de la Santa Creu i Sant Pau
  - Castellon, Spain, 12002
    - Recruiting
    - Consorcio Hospitalario Provincial de Castellon
  - Cáceres, Spain, 10003
    - Recruiting
    - Hospital Universitario San Pedro de Alcantara
  - Córdoba, Spain, 14004
    - Recruiting
    - Hospital Reina Sofia
  - Donostia / San Sebastian, Spain, 20014
    - Recruiting
    - Hospital Donostia
  - Elche, Spain, 03203
    - Recruiting
    - Hospital General Universitario de Elche
  - Fuenlabrada, Spain, 28942
    - Recruiting
    - Hospital Universitario de Fuenlabrada
  - Galdakao, Spain, 48960
    - Recruiting
    - Hospital Galdakao
  - Granada, Spain, 18014
    - Recruiting
    - Hospital Universitario Virgen de Las Nieves
  - Granada, Spain, 18016
    - Recruiting
    - Hospital Universitario Clínico San Cecilio
  - Jaén, Spain, 23007
    - Recruiting
    - Hospital Universitario de Jaén
  - León, Spain, 24008
    - Recruiting
    - H. León
  - Lleida, Spain, 25198
    - Recruiting
    - Hospital Arnau de Vilanova
  - Madrid, Spain, 28007
    - Recruiting
    - Hospital General Universitario Gregorio Marañón
  - Madrid, Spain, 28007
    - Recruiting
    - Hospital Beata Maria Ana
  - Manresa, Spain, 08242
    - Recruiting
    - ALTHAIA Xarxa Assistencial de Manresa
  - Murcia, Spain, 30008
    - Recruiting
    - Hospital General Univers
  - Murcia, Spain, 30008
    - Withdrawn
    - Hospital Universitario Morales Meseguer
  - Málaga, Spain, 29010
    - Recruiting
    - Hospital Universitario Virgen de la Victoria
  - Málaga, Spain, 29011
    - Recruiting
    - Hosp. Mat-Inf. Carlos Haya
  - Pamplona, Spain, 31008
    - Recruiting
    - Clinica Universidad de Navarra - Madrid
  - Reus, Spain, 43204
    - Recruiting
    - Hospital Universitari Sant Joan de Reus
  - San Cristóbal de La Laguna, Spain, 38320
    - Recruiting
    - Hospital Universitario de Canarias
  - Santander, Spain, 39008
    - Recruiting
    - HU Marqués de Valdecilla
  - Seville, Spain, 41009
    - Recruiting
    - Hospital Universitario Virgen Macarena
  - Seville, Spain, 41010
    - Recruiting
    - Hospital Quirónsalud Sagrado Corazón
  - Toledo, Spain, 45007
    - Recruiting
    - Hospital de Toledo
  - Valencia, Spain, 46010
    - Recruiting
    - Hospital Clinico Universitario de Valencia
  - Valencia, Spain, 46014
    - Recruiting
    - Hospital Clinico Universitario de Valencia
  - Valladolid, Spain, 47003
    - Recruiting
    - Hospital Clínico Universitario de Valladolid
  - Zaragoza, Spain, 50009
    - Recruiting
    - Isabel la Catolica nº 1-3
United Kingdom
- - Cottingham, United Kingdom, HU165JQ
    - Not yet recruiting
    - Hull University Teaching Hospitals NHS Trust
  - Liverpool, United Kingdom, L7 8YA
    - Not yet recruiting
    - The Clatterbridge Cancer Centre NHS Foundation Trust
  - London, United Kingdom, SW10 9NH
    - Not yet recruiting
    - Royal Marsden Hospital
  - London, United Kingdom, EC1M 6QB
    - Not yet recruiting
    - Barts Health NHS Trust
  - Manchester, United Kingdom, M20 4BX
    - Recruiting
    - The Christie NHS Foundation Trust
  - Taunton, United Kingdom, TA1 5DA
    - Not yet recruiting
    - Taunton and Somerset NHS Foundation Trust
United States
- Alabama
  - Birmingham, Alabama, United States, 35243
    - Recruiting
    - Alabama Oncology
  - Huntsville, Alabama, United States, 35805
    - Recruiting
    - Clearview Cancer Institute
- Arizona
  - Glendale, Arizona, United States, 85304
    - Recruiting
    - Palo Verde Hematology Oncology
  - Phoenix, Arizona, United States, 85054
    - Withdrawn
    - Mayo Clinic Hospital
  - Prescott Valley, Arizona, United States, 86314
    - Withdrawn
    - Arizona Oncology Associates
- California
  - Berkeley, California, United States, 94704
    - Recruiting
    - Alta Bates Summit Medical Center
  - Clovis, California, United States, 93611
    - Withdrawn
    - Community Cancer Institute
  - Downey, California, United States, 90241
    - Recruiting
    - PIH Health Whittier Hospital
  - Fountain Valley, California, United States, 92708
    - Recruiting
    - Compassionate Cancer Care Medical Group - Inc
  - Los Angeles, California, United States, 90017
    - Recruiting
    - Los Angeles Cancer Network
  - Los Angeles, California, United States, 90033
    - Withdrawn
    - USC Norris Comprehensive Cancer Center
  - Los Angeles, California, United States, 90048
    - Recruiting
    - Cedars-Sinai Cancer at Beverly Hills
  - Newport Beach, California, United States, 92663
    - Recruiting
    - Hoag Memorial Hospital Presbyterian
  - Redlands, California, United States, 92373
    - Withdrawn
    - Emad Ibrahim, MD, INC
  - Sacramento, California, United States, 95816
    - Recruiting
    - Sutter Institute for Medical Research
  - San Francisco, California, United States, 94143
    - Recruiting
    - UCSF Medical Center
  - San Francisco, California, United States, 94143
    - Recruiting
    - City of Hope (Duarte)
  - Santa Barbara, California, United States, 93105
    - Recruiting
    - Sansum Clinic
  - Stockton, California, United States, 95204
    - Recruiting
    - Stockton Hematology Oncology Medical Group
- Colorado
  - Aurora, Colorado, United States, 80045
    - Withdrawn
    - University of Colorado Cancer Center
- Connecticut
  - Danbury, Connecticut, United States, 06810
    - Withdrawn
    - Norwalk Hospital
  - Stamford, Connecticut, United States, 06902
    - Recruiting
    - Stamford Hospital
- District of Columbia
  - Washington D.C., District of Columbia, United States, 20007
    - Recruiting
    - MedStar Georgetown University Hospital
  - Washington D.C., District of Columbia, United States, 20010
    - Recruiting
    - Medstar Washington Hospital Center
- Florida
  - Clearwater, Florida, United States, 00337
    - Withdrawn
    - Morton Plant Hospital - Bay Care
  - Gainesville, Florida, United States, 32610
    - Withdrawn
    - University of Florida
  - Jacksonville, Florida, United States, 32256
    - Recruiting
    - Cancer Specialists of North Florida
  - Jacksonville, Florida, United States, 32224
    - Recruiting
    - Mayo Clinic Florida
  - Jupiter, Florida, United States, 33458
    - Recruiting
    - Jupiter Medical Center
  - Miami Beach, Florida, United States, 33140
    - Recruiting
    - Mount Sinai Comprehensive Cancer Center
  - Orange City, Florida, United States, 32763
    - Withdrawn
    - Midland Florida Clinical Research Center, L
  - Orlando, Florida, United States, 32806
    - Active, not recruiting
    - Orlando Health
  - Palm Bay, Florida, United States, 32909
    - Recruiting
    - Cancer Care Centers of Brevard, Inc
  - Pembroke Pines, Florida, United States, 33028
    - Recruiting
    - Memorial Healthcare System
  - Pensacola, Florida, United States, 32504
    - Withdrawn
    - Sacred Heart Medical Oncology Group
  - Plantation, Florida, United States, 33324
    - Recruiting
    - Sylvester Comprehensive Cancer Center
  - Stuart, Florida, United States, 34994
    - Withdrawn
    - Cleveland Clinic Florida, Martin North Hospital
  - Tampa, Florida, United States, 33614
    - Withdrawn
    - St. Joseph's Hospital
  - Weston, Florida, United States, 33331
    - Withdrawn
    - Weston Hospital
- Georgia
  - Athens, Georgia, United States, 30607
    - Recruiting
    - University Cancer & Blood Center, LLC.
  - Atlanta, Georgia, United States, 30342
    - Recruiting
    - Northside Hospital
  - Atlanta, Georgia, United States, 30318
    - Recruiting
    - Piedmont Cancer Institute
  - Marietta, Georgia, United States, 30060
    - Recruiting
    - Northwest Georgia Oncology Centers, PC
  - Newnan, Georgia, United States, 30265
    - Recruiting
    - Southeastern Regional Medical Center, Inc. dba City of Hope Atlanta
  - Valdosta, Georgia, United States, 31602
    - Recruiting
    - Pearlman Cancer Center
- Idaho
  - Boise, Idaho, United States, 83712
    - Withdrawn
    - St Lukes Mountain States Tumor Institute
  - Coeur d'Alene, Idaho, United States, 83814
    - Recruiting
    - Kootenai Health
- Illinois
  - Chicago, Illinois, United States, 60612
    - Recruiting
    - Rush University Medical Center
  - Chicago, Illinois, United States, 60637
    - Recruiting
    - University of Chicago Medical Center
  - Chicago, Illinois, United States, 60611
    - Recruiting
    - Northwestern Medicine
  - Chicago, Illinois, United States, 60612
    - Withdrawn
    - University of Illinois
  - Evanston, Illinois, United States, 60201
    - Recruiting
    - Northshore University Healthsystem
  - Naperville, Illinois, United States, 60540
    - Recruiting
    - Edward Hospital
  - River Forest, Illinois, United States, 60305
    - Withdrawn
    - West Suburban Medical Center- River Forest
  - Skokie, Illinois, United States, 60076
    - Withdrawn
    - Edward H. Kaplan MD & Associates - Hematology/Oncology of the North Shore
  - Springfield, Illinois, United States, 62702
    - Withdrawn
    - Springfield Clinic LLP
  - Urbana, Illinois, United States, 61801
    - Recruiting
    - Carle Cancer Center
- Indiana
  - Indianapolis, Indiana, United States, 46237
    - Recruiting
    - Franciscan Health Indianapolis
  - Indianapolis, Indiana, United States, 46260
    - Withdrawn
    - Investigative Clinical Research of Indiana, LLC
  - Lafayette, Indiana, United States, 47904
    - Withdrawn
    - IU Health Arnett Hospital
  - Munster, Indiana, United States, 46321
    - Withdrawn
    - Franciscan Health Munster
- Iowa
  - Cedar Rapids, Iowa, United States, 52403
    - Withdrawn
    - Mercy Medical Center
  - Des Moines, Iowa, United States, 50309
    - Recruiting
    - Mission Cancer & Blood - John Stoddard Cancer Center
  - Iowa City, Iowa, United States, 52242
    - Recruiting
    - University of Iowa Hospitals and Clinics
- Kentucky
  - Lexington, Kentucky, United States, 40536
    - Withdrawn
    - University of Kentucky
  - Louisville, Kentucky, United States, 40207
    - Recruiting
    - Norton Healthcare, Inc.
  - Paducah, Kentucky, United States, 42003
    - Recruiting
    - Mercy Health
- Louisiana
  - Baton Rouge, Louisiana, United States, 70809
    - Recruiting
    - Mary Bird Perkins Cancer Center
  - New Orleans, Louisiana, United States, 70112
    - Withdrawn
    - University Medical Center New Orleans
- Maine
  - Scarborough, Maine, United States, 04074
    - Recruiting
    - New England Cancer Specialists
- Maryland
  - Baltimore, Maryland, United States, 21231
    - Recruiting
    - Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
  - Baltimore, Maryland, United States, 21215
    - Recruiting
    - Sinai Hospital of Baltimore, Inc.
  - Baltimore, Maryland, United States, 21229
    - Recruiting
    - St. Agnes Hospital
  - Bethesda, Maryland, United States, 20817
    - Withdrawn
    - American Oncology Partners of Maryland, PA
  - Frederick, Maryland, United States, 21702
    - Recruiting
    - James M Stockman Cancer Institute
  - Towson, Maryland, United States, 21204
    - Recruiting
    - Greater Baltimore Medical Center
- Massachusetts
  - Boston, Massachusetts, United States, 02115
    - Recruiting
    - Massachusetts General Hospital
  - Boston, Massachusetts, United States, 02215
    - Recruiting
    - Beth Israel Deaconess Medical Center
  - Boston, Massachusetts, United States, 02215
    - Recruiting
    - Dana Farber Cancer Institute
  - Boston, Massachusetts, United States, 02111
    - Recruiting
    - Tufts Medical Center
  - Foxborough, Massachusetts, United States, 02035
    - Recruiting
    - Dana-Farber Cancer Institute @Foxborough
  - Methuen, Massachusetts, United States, 01844
    - Recruiting
    - Dana-Farber Cancer Institude at Merrimack Valley
  - Milford, Massachusetts, United States, 01757
    - Recruiting
    - Dana Farber Cancer Institute @ Milford Regional Hospital
  - South Weymouth, Massachusetts, United States, 02190
    - Recruiting
    - Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) in Clinical Affiliation with South Shore Hospital
  - Springfield, Massachusetts, United States, 01199
    - Withdrawn
    - Baystate Medical Center Inc.
  - Worcester, Massachusetts, United States, 01655
    - Withdrawn
    - University of Massachusetts Worcester
- Michigan
  - Detroit, Michigan, United States, 48202
    - Withdrawn
    - Henry Ford Health System
  - Grand Rapids, Michigan, United States, 49503
    - Recruiting
    - Cancer and Hematology Centers of Western Michigan
  - Grosse Pointe Woods, Michigan, United States, 48236
    - Withdrawn
    - Ascension
  - Royal Oak, Michigan, United States, 48073
    - Recruiting
    - William Beaumont Hospital
  - Southfield, Michigan, United States, 48075
    - Withdrawn
    - Ascension Providence Hospital Southfield Cancer Center
  - Ypsilanti, Michigan, United States, 48197
    - Withdrawn
    - Trinity Health St. Joseph Mercy Ann Arbor
- Minnesota
  - Maplewood, Minnesota, United States, 55109
    - Recruiting
    - Minnesota Oncology Hematology, PA
  - Minneapolis, Minnesota, United States, 55455
    - Recruiting
    - University of Minnesota Medical Center, Fairview
  - Minneapolis, Minnesota, United States, 55407
    - Recruiting
    - Virginia Piper Cancer Center (Allina Health)
  - Rochester, Minnesota, United States, 55905
    - Recruiting
    - Mayo Clinic Rochester
  - Saint Louis Park, Minnesota, United States, 55426
    - Recruiting
    - Metro Minnesota Community Oncology
- Missouri
  - St Louis, Missouri, United States, 63110
    - Recruiting
    - Washington University School of Medicine
  - St Louis, Missouri, United States, 63131
    - Recruiting
    - Baptist Clinical Research Institute
  - St Louis, Missouri, United States, 63141
    - Withdrawn
    - Mercy Hospital
- Nebraska
  - Hastings, Nebraska, United States, 68901
    - Recruiting
    - Mary Lanning Healthcare - Morrison Cancer Center
  - Omaha, Nebraska, United States, 68114
    - Recruiting
    - Oncology Hematology West - Methodist
  - Omaha, Nebraska, United States, 68124
    - Recruiting
    - Nebraska Methodist Hospital (change from Chi Health Bergan Mercy)
- Nevada
  - Las Vegas, Nevada, United States, 89169
    - Withdrawn
    - Comprehensive Cancer Centers of Nevada
  - Reno, Nevada, United States, 89511
    - Withdrawn
    - Cancer Care & Hematology Specialists
- New Jersey
  - East Brunswick, New Jersey, United States, 08816
    - Recruiting
    - Regional Cancer Care Associates LLC
  - Flemington, New Jersey, United States, 08822
    - Recruiting
    - Hunterdon Medical Center
  - Florham Park, New Jersey, United States, 07932
    - Withdrawn
    - Summit Medical Group, P.A.
  - New Brunswick, New Jersey, United States, 08901
    - Recruiting
    - Rutgers Health
  - Summit, New Jersey, United States, 07901
    - Recruiting
    - Overlook Medical Center
- New Mexico
  - Albuquerque, New Mexico, United States, 87131
    - Recruiting
    - University of New Mexico
  - Farmington, New Mexico, United States, 87401
    - Recruiting
    - San Juan Oncology Associates
- New York
  - Amsterdam, New York, United States, 12010
    - Withdrawn
    - New York Oncology Hematology (NYOH)
  - Buffalo, New York, United States, 14263
    - Withdrawn
    - Roswell Park Cancer Institute
  - East Syracuse, New York, United States, 13057
    - Recruiting
    - Hematology Oncology Associates of Central New York, PC
  - Lake Success, New York, United States, 11042
    - Recruiting
    - Northwell Health
  - New York, New York, United States, 10016
    - Recruiting
    - Laura and Isaac Perlmutter Cancer Canter
  - Rochester, New York, United States, 14618
    - Recruiting
    - Lipson Cancer Institute - Linden Oaks
  - Shirley, New York, United States, 11967
    - Recruiting
    - New York Cancer and Blood Specialists
  - Stony Brook, New York, United States, 11794
    - Recruiting
    - Stony Brook Medicine
  - Syracuse, New York, United States, 13210
    - Recruiting
    - SUNY Upstate Medical University
  - The Bronx, New York, United States, 10467
    - Withdrawn
    - Montefiore Medical Center
  - Westbury, New York, United States, 11590
    - Withdrawn
    - Clinical Research Alliance
  - White Plains, New York, United States, 10601
    - Recruiting
    - White Plains Hospital Physician Associates
- North Carolina
  - Chapel Hill, North Carolina, United States, 27514
    - Recruiting
    - Lineberger Comprehensive Cancer Center
  - Durham, North Carolina, United States, 27710
    - Recruiting
    - Duke Cancer Institute
  - Greensboro, North Carolina, United States, 27403
    - Recruiting
    - Cone Health Medical Group (Moses Cone Health System)
  - Greenville, North Carolina, United States, 27834
    - Withdrawn
    - East Carolina University Health Medical Center
  - Pinehurst, North Carolina, United States, 28374
    - Withdrawn
    - FirstHealth Outpatient Cancer Center
  - Raleigh, North Carolina, United States, 27607
    - Withdrawn
    - UNC REX Cancer Center
  - Rocky Mount, North Carolina, United States, 27804
    - Withdrawn
    - UNC Nash Cancer Center
  - Winston-Salem, North Carolina, United States, 27157
    - Recruiting
    - Atrium Health Wake Forest Baptist
- Ohio
  - Cincinnati, Ohio, United States, 45242
    - Recruiting
    - Oncology Hematology Care, Inc.
  - Cincinnati, Ohio, United States, 45220
    - Recruiting
    - Good Samaritan Hospital
  - Columbus, Ohio, United States, 43214
    - Recruiting
    - Ohio Health Research Institute
  - Columbus, Ohio, United States, 43215
    - Recruiting
    - Columbus NCORP
  - Columbus, Ohio, United States, 43221
    - Recruiting
    - Anita Stewart Oncology Center
  - Columbus, Ohio, United States, 43212
    - Recruiting
    - Ohio State University CRS
  - Toledo, Ohio, United States, 43623
    - Not yet recruiting
    - Toledo Clinic Cancer Center
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73104
    - Withdrawn
    - University of Oklahoma Health Sciences Center
- Oregon
  - Bend, Oregon, United States, 97701
    - Recruiting
    - St. Charles Health System, Inc. DBA St. Charles Medical Center
  - Corvallis, Oregon, United States, 97330
    - Recruiting
    - Samaritan Hospital
  - Eugene, Oregon, United States, 97401
    - Recruiting
    - Willamette Valley Cancer Institute and Research Center
  - Medford, Oregon, United States, 97504
    - Withdrawn
    - Asante Rogue Regional Medical Center
  - Portland, Oregon, United States, 97239
    - Recruiting
    - Oregon Health & Science University
  - Portland, Oregon, United States, 97213
    - Withdrawn
    - Providence Cancer Institute - Oncology Clinical Trials
- Pennsylvania
  - Bethlehem, Pennsylvania, United States, 18015
    - Withdrawn
    - Saint Luke's University Hospital
  - Lancaster, Pennsylvania, United States, 17601
    - Recruiting
    - Lancaster General Health
  - Philadelphia, Pennsylvania, United States, 19104
    - Recruiting
    - University of Pennsylvania Abramson Cancer Center
  - Pittsburgh, Pennsylvania, United States, 15213
    - Recruiting
    - UPMC Magee-Womens Hospital
  - Sayre, Pennsylvania, United States, 18840
    - Recruiting
    - Guthrie Clinical Research
  - West Reading, Pennsylvania, United States, 19611
    - Withdrawn
    - Reading Hospital and Medical Center
  - Wynnewood, Pennsylvania, United States, 19106
    - Recruiting
    - Lankenau Medical Center
  - York, Pennsylvania, United States, 17403
    - Recruiting
    - Cancer Care Associates of York
- Rhode Island
  - Providence, Rhode Island, United States, 02905
    - Recruiting
    - Providence Health
- South Carolina
  - Charleston, South Carolina, United States, 29425
    - Recruiting
    - Medical University of South Carolina
  - Spartanburg, South Carolina, United States, 29303
    - Recruiting
    - Spartanburg Medical Center
- South Dakota
  - Rapid City, South Dakota, United States, 57701
    - Recruiting
    - Monument Health Cancer Care Institute
  - Sioux Falls, South Dakota, United States, 57105
    - Recruiting
    - Avera Cancer Institute
- Tennessee
  - Kingsport, Tennessee, United States, 37660
    - Withdrawn
    - Ballad Health Cancer Care - Kingsport
  - Knoxville, Tennessee, United States, 37920
    - Recruiting
    - University of Tennessee
  - Knoxville, Tennessee, United States, 37909
    - Withdrawn
    - Center for Biomedical Research, LLC
- Texas
  - Abilene, Texas, United States, 79601
    - Withdrawn
    - Hendrick Health System
  - Austin, Texas, United States, 78731
    - Recruiting
    - Texas Oncology
  - El Paso, Texas, United States, 79902
    - Recruiting
    - Texas Oncology
  - Houston, Texas, United States, 77030
    - Recruiting
    - MD Anderson Cancer Center
  - Lubbock, Texas, United States, 79410
    - Withdrawn
    - Joe Arrington Cancer Research and Treatment Center
  - San Antonio, Texas, United States, 78240
    - Recruiting
    - Texas Oncology
- Utah
  - Salt Lake City, Utah, United States, 84112
    - Recruiting
    - Huntsman Cancer Institute
- Virginia
  - Charlottesville, Virginia, United States, 22908
    - Recruiting
    - University of Virginia
  - Fairfax, Virginia, United States, 22031
    - Recruiting
    - Inova Fairfax Hospital
  - Midlothian, Virginia, United States, 23114
    - Recruiting
    - Bon Secours Cancer Institute at St. Francis
  - Richmond, Virginia, United States, 23298
    - Withdrawn
    - Virginia Commonwealth University Medical Center
  - Wytheville, Virginia, United States, 24382
    - Recruiting
    - Oncology and Hematology Associates of Southwest Virginia, Inc
- Washington
  - Lacey, Washington, United States, 98503
    - Recruiting
    - Providence Regional Cancer System
  - Puyallup, Washington, United States, 98373
    - Recruiting
    - NorthWest Medical Specialties, PLLC
  - Puyallup, Washington, United States, 98372
    - Recruiting
    - MultiCare Regional Cancer Center - Tacoma
  - Renton, Washington, United States, 98055
    - Withdrawn
    - University of Washington
  - Spokane, Washington, United States, 99208
    - Withdrawn
    - Medical Oncology Associates
- West Virginia
  - Morgantown, West Virginia, United States, 26505
    - Recruiting
    - West Virginia University Hospital
- Wisconsin
  - Appleton, Wisconsin, United States, 54911
    - Withdrawn
    - ThedaCare Regional Cancer Center
  - Franklin, Wisconsin, United States, 53132
    - Recruiting
    - Ascension St. Francis Reiman Cancer Center
  - Green Bay, Wisconsin, United States, 54303
    - Withdrawn
    - HSHS Saint Mary's Hospital Medical Center - Green Bay
  - Madison, Wisconsin, United States, 53792
    - Withdrawn
    - University of Wisconsin

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Key Inclusion Criteria:

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.

Key Exclusion Criteria:

Stage IV (metastatic) breast cancer as well as history of any prior (ipsi- or contralateral) invasive breast cancer.
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.
Evidence of recurrent disease following preoperative therapy and surgery.
Prior treatment with topoisomerase 1 inhibitors or antibody-drug conjugates (ADCs) containing a topoisomerase inhibitor.
Individuals with germline breast cancer gene (BRCA) mutations.
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%
Active serious infections requiring anti-microbial therapy.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sacituzumab govitecan-hziy (SG) + Pembrolizumab Participants will receive SG 10 mg/kg intravenously on Days 1 and 8 of 21-day cycles and pembrolizumab 200 mg intravenously on Day 1 of 21-day cycles for 8 cycles. Treatment will be administered until a maximum of 8 cycles, local or distant disease recurrence, unacceptable toxicity, physician decision, consent withdrawal, or death.	Drug: Pembrolizumab Administered intravenously Other Names: KEYTRUDA® Drug: Sacituzumab govitecan-hziy (SG) Administered intravenously Other Names: IMMU-132 GS-0132 Trodelvy™
Active Comparator: Treatment of Physician's Choice (TPC): Pembrolizumab or Pembrolizumab + Capecitabine Participants will receive one of the following TPC regimens determined prior to randomization: Pembrolizumab 200 mg intravenously on Day 1 of 21-day cycles for 8 cycles OR Pembrolizumab 200 mg intravenously on Day 1 of 21-day cycles and capecitabine 1000 mg/m^2 orally twice daily on Days 1 through 14 of 21-day cycles for 8 cycles. Treatment will be administered until a maximum of 8 cycles, local or distant disease recurrence, unacceptable toxicity, physician decision, consent withdrawal, or death.	Drug: Pembrolizumab Administered intravenously Other Names: KEYTRUDA® Drug: Capecitabine Tablets administered orally Other Names: Xeloda

Participant Group / Arm

Intervention / Treatment

Experimental: Sacituzumab govitecan-hziy (SG) + Pembrolizumab

Participants will receive SG 10 mg/kg intravenously on Days 1 and 8 of 21-day cycles and pembrolizumab 200 mg intravenously on Day 1 of 21-day cycles for 8 cycles.

Treatment will be administered until a maximum of 8 cycles, local or distant disease recurrence, unacceptable toxicity, physician decision, consent withdrawal, or death.

Drug: Pembrolizumab

Administered intravenously

Other Names:

KEYTRUDA®

Drug: Sacituzumab govitecan-hziy (SG)

Administered intravenously

Other Names:

IMMU-132
GS-0132
Trodelvy™

Active Comparator: Treatment of Physician's Choice (TPC): Pembrolizumab or Pembrolizumab + Capecitabine

Participants will receive one of the following TPC regimens determined prior to randomization:

Pembrolizumab 200 mg intravenously on Day 1 of 21-day cycles for 8 cycles OR
Pembrolizumab 200 mg intravenously on Day 1 of 21-day cycles and capecitabine 1000 mg/m^2 orally twice daily on Days 1 through 14 of 21-day cycles for 8 cycles.

Treatment will be administered until a maximum of 8 cycles, local or distant disease recurrence, unacceptable toxicity, physician decision, consent withdrawal, or death.

Drug: Pembrolizumab

Administered intravenously

Other Names:

KEYTRUDA®

Drug: Capecitabine

Tablets administered orally

Other Names:

Xeloda

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Invasive Disease-free Survival (iDFS) Time Frame: Up to 60 months	iDFS is defined as the time from the date of randomization to death from any cause or one of the following events (whichever occurs first): invasive local, regional, or distant recurrence, invasive contralateral breast cancer.	Up to 60 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS) Time Frame: Up to 96 months	OS is defined as the time from the date of randomization until death due to any cause.	Up to 96 months
Distant Disease-free Survival (dDFS) Time Frame: Up to 60 months	dDFS is defined as the time from the date of randomization to death from any cause or one of the following events (whichever occurs first): distant recurrence, or second primary invasive cancer.	Up to 60 months
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) Time Frame: First dose date up to 38 months plus 30 days		First dose date up to 38 months plus 30 days
Percentage of Participants Experiencing Laboratory Abnormalities Time Frame: First dose date up to 38 months plus 30 days		First dose date up to 38 months plus 30 days
Time to Worsening (TTW) of Quality of Life (QoL) Based on Functional Assessment of Cancer Therapy for Breast Cancer (FACT-B) Trial Outcome Index (TOI) Scores Time Frame: Up to 60 months	TTW of FACT-B TOI scores will be analyzed for each index, the TTW of FACT-B scores will be measured from the randomization date and to the time the participants first experienced a first score of worsening.	Up to 60 months
Recurrence-free Survival (RFS) Time Frame: Up to 60 months	RFS is defined as the time from the date of randomization to death from any cause or one of the following events (whichever occurs first): invasive local, regional, or distant recurrence.	Up to 60 months

Collaborators and Investigators

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

Sponsor

Gilead Sciences

Collaborators

Alliance Foundation Trials, LLC.

NSABP Foundation Inc

GBG Forschungs GmbH

Investigators

Study Director: Gilead Study Director, Gilead Sciences

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.

General Publications

Tolaney SM, DeMichele A, Takano T, Rugo HS, Perou C, Lynce F, Parsons HA, Santa-Maria CA, Rocque GB, Yao W, Sun SW, Mocci S, Partridge AH, Carey LA. OptimICE-RD: sacituzumab govitecan + pembrolizumab vs pembrolizumab (+/- capecitabine) for residual triple-negative breast cancer. Future Oncol. 2024;20(31):2343-2355. doi: 10.1080/14796694.2024.2357534. Epub 2024 Jun 26.

Helpful Links

Gilead Clinical Trials Website

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)

December 12, 2022

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

August 1, 2031

Study Registration Dates

First Submitted

November 21, 2022

First Submitted That Met QC Criteria

November 21, 2022

First Posted (Actual)

December 1, 2022

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

GS-US-595-6184
2024-512279-10 (Other Identifier: European Medicines Agency)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

General Publications

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Triple Negative Breast Cancer

Clinical Trials on Pembrolizumab

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