Triple Negative Breast CancerPhase 3NCT05633654
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)
A Phase 3 study testing Sacituzumab govitecan-hziy (SG), Pembrolizumab and Capecitabine in people with Triple Negative Breast Cancer, run by Gilead Sciences at 376 sites in 12 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple Negative Breast Cancer
- What is being tested?
- Sacituzumab govitecan-hziy (SG), Pembrolizumab and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,514 participants
- Where
- 376 sitesin 12 countries
- Study dates
- 12 Dec 2022to Aug 2031
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
376 sites in 12 countries. Contact the study team or a site near you to ask about taking part.
Gilead Clinical Study Information Center contact
376 sites in 12 countries
United States188 sites, 122 recruiting
- Withdrawn
Hendrick Health System
Abilene, Texas, 79601
- Recruiting
University of New Mexico
Albuquerque, New Mexico, 87131
- Withdrawn
New York Oncology Hematology (NYOH)
Amsterdam, New York, 12010
- Withdrawn
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911
- Recruiting
University Cancer & Blood Center, LLC.
Athens, Georgia, 30607
- Recruiting
Piedmont Cancer Institute
Atlanta, Georgia, 30318
- Recruiting
Northside Hospital
Atlanta, Georgia, 30342
- Withdrawn
University of Colorado Cancer Center
Aurora, Colorado, 80045
- Recruiting
Texas Oncology
Austin, Texas, 78731
- Recruiting
Sinai Hospital of Baltimore, Inc.
Baltimore, Maryland, 21215
- Recruiting
St. Agnes Hospital
Baltimore, Maryland, 21229
- Recruiting
Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231
- Recruiting
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809
- Recruiting
St. Charles Health System, Inc. DBA St. Charles Medical Center
Bend, Oregon, 97701
- Recruiting
Alta Bates Summit Medical Center
Berkeley, California, 94704
- Withdrawn
American Oncology Partners of Maryland, PA
Bethesda, Maryland, 20817
- Withdrawn
Saint Luke's University Hospital
Bethlehem, Pennsylvania, 18015
- Recruiting
Alabama Oncology
Birmingham, Alabama, 35243
- Withdrawn
St Lukes Mountain States Tumor Institute
Boise, Idaho, 83712
- Recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02115
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
- Withdrawn
Roswell Park Cancer Institute
Buffalo, New York, 14263
- Withdrawn
Mercy Medical Center
Cedar Rapids, Iowa, 52403
- Recruiting
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27514
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
- Recruiting
Novant Health Cancer Institute - Elizabeth (Breast)
Charlotte, North Carolina, 28204
- Recruiting
University of Virginia
Charlottesville, Virginia, 22908
- Recruiting
Northwestern Medicine
Chicago, Illinois, 60611
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
- Withdrawn
University of Illinois
Chicago, Illinois, 60612
- Recruiting
University of Chicago Medical Center
Chicago, Illinois, 60637
- Recruiting
Good Samaritan Hospital
Cincinnati, Ohio, 45220
- Recruiting
Oncology Hematology Care, Inc.
Cincinnati, Ohio, 45242
- Withdrawn
Morton Plant Hospital - Bay Care
Clearwater, Florida, 00337
- Withdrawn
Community Cancer Institute
Clovis, California, 93611
- Recruiting
Kootenai Health
Coeur d'Alene, Idaho, 83814
- Recruiting
Ohio State University CRS
Columbus, Ohio, 43212
- Recruiting
Ohio Health Research Institute
Columbus, Ohio, 43214
- Withdrawn
Columbus NCORP
Columbus, Ohio, 43215
- Recruiting
Anita Stewart Oncology Center
Columbus, Ohio, 43221
- Recruiting
Samaritan Hospital
Corvallis, Oregon, 97330
- Withdrawn
Norwalk Hospital
Danbury, Connecticut, 06810
- Recruiting
Mission Cancer & Blood - John Stoddard Cancer Center
Des Moines, Iowa, 50309
- Withdrawn
Henry Ford Health System
Detroit, Michigan, 48202
- Recruiting
PIH Health Whittier Hospital
Downey, California, 90241
- Recruiting
Duke Cancer Institute
Durham, North Carolina, 27710
- Recruiting
Regional Cancer Care Associates LLC
East Brunswick, New Jersey, 08816
- Recruiting
Hematology Oncology Associates of Central New York, PC
East Syracuse, New York, 13057
- Recruiting
Texas Oncology
El Paso, Texas, 79902
- Recruiting
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, 97401
- Recruiting
NorthShore University Healthsystem
Evanston, Illinois, 60201
- Recruiting
Inova Fairfax Hospital
Fairfax, Virginia, 22031
- Recruiting
San Juan Oncology Associates
Farmington, New Mexico, 87401
- Recruiting
Hunterdon Medical Center
Flemington, New Jersey, 08822
- Withdrawn
Summit Medical Group, P.A.
Florham Park, New Jersey, 07932
- Active, not recruiting
Compassionate Cancer Care Medical Group - Inc
Fountain Valley, California, 92708
- Recruiting
Dana-Farber Cancer Institute @Foxborough
Foxborough, Massachusetts, 02035
- Recruiting
Ascension St. Francis Reiman Cancer Center
Franklin, Wisconsin, 53132
- Recruiting
James M Stockman Cancer Institute
Frederick, Maryland, 21702
- Withdrawn
University of Florida
Gainesville, Florida, 32610
- Recruiting
Palo Verde Hematology Oncology
Glendale, Arizona, 85304
- Recruiting
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49503
- Withdrawn
HSHS Saint Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, 54303
- Recruiting
Cone Health Medical Group (Moses Cone Health System)
Greensboro, North Carolina, 27403
- Withdrawn
East Carolina University Health Medical Center
Greenville, North Carolina, 27834
- Recruiting
St. Francis Cancer Center
Greenville, South Carolina, 29607
- Withdrawn
Ascension
Grosse Pointe Woods, Michigan, 48236
- Active, not recruiting
Mary Lanning Healthcare - Morrison Cancer Center
Hastings, Nebraska, 68901
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
Clearview Cancer Institute
Huntsville, Alabama, 35805
- Recruiting
Franciscan Health Indianapolis
Indianapolis, Indiana, 46237
- Withdrawn
Investigative Clinical Research of Indiana, LLC
Indianapolis, Indiana, 46260
- Recruiting
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
- Recruiting
Mayo Clinic Florida
Jacksonville, Florida, 32224
- Recruiting
Cancer Specialists of North Florida
Jacksonville, Florida, 32256
- Recruiting
Jupiter Medical Center
Jupiter, Florida, 33458
- Withdrawn
Ballad Health Cancer Care - Kingsport
Kingsport, Tennessee, 37660
- Withdrawn
Center for Biomedical Research, LLC
Knoxville, Tennessee, 37909
- Recruiting
University of Tennessee
Knoxville, Tennessee, 37920
- Recruiting
Providence Regional Cancer System
Lacey, Washington, 98503
- Withdrawn
IU Health Arnett Hospital
Lafayette, Indiana, 47904
- Recruiting
Northwell Health
Lake Success, New York, 11042
- Recruiting
Lancaster General Health
Lancaster, Pennsylvania, 17601
- Withdrawn
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
- Withdrawn
University of Kentucky
Lexington, Kentucky, 40536
- Active, not recruiting
Los Angeles Cancer Network
Los Angeles, California, 90017
- Withdrawn
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
- Recruiting
Cedars-Sinai Cancer at Beverly Hills
Los Angeles, California, 90048
- Recruiting
Norton Healthcare, Inc.
Louisville, Kentucky, 40207
- Withdrawn
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410
- Withdrawn
University of Wisconsin
Madison, Wisconsin, 53792
- Recruiting
Minnesota Oncology Hematology, PA
Maplewood, Minnesota, 55109
- Recruiting
Northwest Georgia Oncology Centers, PC
Marietta, Georgia, 30060
- Withdrawn
Asante Rogue Regional Medical Center
Medford, Oregon, 97504
- Recruiting
Dana-Farber Cancer Institude at Merrimack Valley
Methuen, Massachusetts, 01844
- Recruiting
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140
- Recruiting
Bon Secours Cancer Institute at St. Francis
Midlothian, Virginia, 23114
- Recruiting
Dana Farber Cancer Institute @ Milford Regional Hospital
Milford, Massachusetts, 01757
- Recruiting
Virginia Piper Cancer Center (Allina Health)
Minneapolis, Minnesota, 55407
- Recruiting
University of Minnesota Medical Center, Fairview
Minneapolis, Minnesota, 55455
- Recruiting
West Virginia University Hospital
Morgantown, West Virginia, 26505
- Withdrawn
Franciscan Health Munster
Munster, Indiana, 46321
- Recruiting
Edward Hospital
Naperville, Illinois, 60540
- Recruiting
Rutgers Health
New Brunswick, New Jersey, 08901
- Withdrawn
University Medical Center New Orleans
New Orleans, Louisiana, 70112
- Recruiting
University Medical Center - New Orleans
New Orleans, Louisiana, 70122
- Recruiting
Laura and Isaac Perlmutter Cancer Canter
New York, New York, 10016
- Recruiting
Southeastern Regional Medical Center, Inc. dba City of Hope Atlanta
Newnan, Georgia, 30265
- Recruiting
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
- Withdrawn
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
- Recruiting
Oncology Hematology West - Methodist
Omaha, Nebraska, 68114
- Recruiting
Nebraska Methodist Hospital (change from Chi Health Bergan Mercy)
Omaha, Nebraska, 68124
- Withdrawn
Midland Florida Clinical Research Center, L
Orange City, Florida, 32763
- Active, not recruiting
Orlando Health
Orlando, Florida, 32806
- Recruiting
Mercy Health
Paducah, Kentucky, 42003
- Recruiting
Cancer Care Centers of Brevard, Inc
Palm Bay, Florida, 32909
- Recruiting
Memorial Healthcare System
Pembroke Pines, Florida, 33028
- Withdrawn
Sacred Heart Medical Oncology Group
Pensacola, Florida, 32504
- Recruiting
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
- Withdrawn
Mayo Clinic Hospital
Phoenix, Arizona, 85054
- Withdrawn
FirstHealth Outpatient Cancer Center
Pinehurst, North Carolina, 28374
- Recruiting
UPMC Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
- Recruiting
Sylvester Comprehensive Cancer Center
Plantation, Florida, 33324
- Withdrawn
Providence Cancer Institute - Oncology Clinical Trials
Portland, Oregon, 97213
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
- Withdrawn
Arizona Oncology Associates
Prescott Valley, Arizona, 86314
- Recruiting
Providence Health
Providence, Rhode Island, 02905
- Recruiting
MultiCare Regional Cancer Center - Tacoma
Puyallup, Washington, 98372
- Recruiting
Northwest Medical Specialties, PLLC
Puyallup, Washington, 98373
- Withdrawn
UNC Rex Cancer Center
Raleigh, North Carolina, 27607
- Recruiting
Monument Health Cancer Care Institute
Rapid City, South Dakota, 57701
- Withdrawn
Emad Ibrahim, MD, INC
Redlands, California, 92373
- Withdrawn
Cancer Care & Hematology Specialists
Reno, Nevada, 89511
- Withdrawn
University of Washington
Renton, Washington, 98055
- Withdrawn
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298
- Withdrawn
West Suburban Medical Center- River Forest
River Forest, Illinois, 60305
- Recruiting
Mayo Clinic Rochester
Rochester, Minnesota, 55905
- Recruiting
Lipson Cancer Institute - Linden Oaks
Rochester, New York, 14618
- Withdrawn
UNC Nash Cancer Center
Rocky Mount, North Carolina, 27804
- Recruiting
William Beaumont Hospital
Royal Oak, Michigan, 48073
- Recruiting
Sutter Institute for Medical Research
Sacramento, California, 95816
- Recruiting
Metro Minnesota Community Oncology
Saint Louis Park, Minnesota, 55426
- Recruiting
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
- Recruiting
Texas Oncology
San Antonio, Texas, 78240
- Recruiting
City of Hope (Duarte)
San Francisco, California, 94143
- Recruiting
UCSF Medical Center
San Francisco, California, 94143
- Recruiting
Sansum Clinic
Santa Barbara, California, 93105
- Recruiting
Guthrie Clinical Research
Sayre, Pennsylvania, 18840
- Recruiting
New England Cancer Specialists
Scarborough, Maine, 04074
- Recruiting
New York Cancer and Blood Specialists
Shirley, New York, 11967
- Recruiting
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
- Withdrawn
Edward H. Kaplan MD & Associates - Hematology/Oncology of the North Shore
Skokie, Illinois, 60076
- Recruiting
Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) in Clinical Affiliation with South Shore Hospital
South Weymouth, Massachusetts, 02190
- Withdrawn
Ascension Providence Hospital Southfield Cancer Center
Southfield, Michigan, 48075
- Recruiting
Spartanburg Medical Center
Spartanburg, South Carolina, 29303
- Withdrawn
Medical Oncology Associates
Spokane, Washington, 99208
- Withdrawn
Springfield Clinic LLP
Springfield, Illinois, 62702
- Withdrawn
Baystate Medical Center Inc.
Springfield, Massachusetts, 01199
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
- Withdrawn
Baptist Clinical Research Institute
St Louis, Missouri, 63131
- Withdrawn
Mercy Hospital
St Louis, Missouri, 63141
- Recruiting
Stamford Hospital
Stamford, Connecticut, 06902
- Recruiting
Stockton Hematology Oncology Medical Group
Stockton, California, 95204
- Recruiting
Stony Brook Medicine
Stony Brook, New York, 11794
- Withdrawn
Cleveland Clinic Florida, Martin North Hospital
Stuart, Florida, 34994
- Recruiting
Overlook Medical Center
Summit, New Jersey, 07901
- Recruiting
SUNY Upstate Medical University
Syracuse, New York, 13210
- Withdrawn
St. Joseph's Hospital
Tampa, Florida, 33614
- Withdrawn
Montefiore Medical Center
The Bronx, New York, 10467
- Withdrawn
Toledo Clinic Cancer Center
Toledo, Ohio, 43623
- Recruiting
Greater Baltimore Medical Center
Towson, Maryland, 21204
- Recruiting
Carle Cancer Center
Urbana, Illinois, 61801
- Recruiting
Pearlman Cancer Center
Valdosta, Georgia, 31602
- Recruiting
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
- Recruiting
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
- Withdrawn
Reading Hospital and Medical Center
West Reading, Pennsylvania, 19611
- Withdrawn
Clinical Research Alliance
Westbury, New York, 11590
- Withdrawn
Weston Hospital
Weston, Florida, 33331
- Recruiting
White Plains Hospital Physician Associates
White Plains, New York, 10601
- Recruiting
Cancer Center of Kansas
Wichita, Kansas, 67214
- Recruiting
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
- Withdrawn
University of Massachusetts Worcester
Worcester, Massachusetts, 01655
- Recruiting
Lankenau Medical Center
Wynnewood, Pennsylvania, 19106
- Recruiting
Oncology and Hematology Associates of Southwest Virginia, Inc
Wytheville, Virginia, 24382
- Recruiting
Cancer Care Associates of York
York, Pennsylvania, 17403
- Withdrawn
Trinity Health St. Joseph Mercy Ann Arbor
Ypsilanti, Michigan, 48197
Germany52 sites, 46 recruiting
- Recruiting
Hämatologie-Onkologie im Zentrum MVZ GmbH
Augsburg, 86150
- Active, not recruiting
Schwanebecker Chaussee 50
Berlin, 13125
- Recruiting
Möllendorffstr. 52, 10367 Berlin 2. Behandlungsstandort: Markt 2-3, 13597 Berlin
Berlin, 13597
- Recruiting
Teutoburger Str. 60
Bielefeld, 33604
- Recruiting
Josef-Albers-Str.70
Bottrop, 46236
- Recruiting
Studien GbR Braunschweig
Braunschweig, 38100
- Withdrawn
Klinikum Bremen-Mitte
Bremen, 28205
- Recruiting
Hämato-Onkologische Praxis im Medicum
Bremen, 28209
- Recruiting
St. Elisabeth Krankenhaus GmbH
Cologne, 50935
- Recruiting
St. Johannes Hospital
Dortmund, 44137
- Recruiting
Fetscherstraße ,74
Dresden, 01307
- Recruiting
Kostara Gyn. Oncology Clinic Research UG
Düsseldorf, 40235
- Recruiting
Universitätsstraße, 21-23
Erlangen, 91054
- Recruiting
Henricistraße 92, 45136 Essen, Germany
Essen, 45136
- Recruiting
Klinikum Esslingen
Esslingen am Neckar, 73730
- Recruiting
Wilhelm-Epstein-Str. 4
Frankfurt, 60431
- Recruiting
Gotenstraße 6-8
Frankfurt am Main, 65929
- Recruiting
Hugstetter Str. 55
Freiburg im Breisgau, 79106
- Recruiting
Munckelstrasse 27
Gelsenkirchen, 45879
- Recruiting
MVZ II der Niels Stensen Kliniken
Georgsmarienhütte, 49124
- Recruiting
Straße des Friedens 122
Gera, 7548
- Recruiting
Hohe Weide 17b
Hamburg, 20259
- Recruiting
Moorkamp 2-6
Hamburg, 20357
- Recruiting
Am Klinikum 1
Jena, 07447
- Active, not recruiting
Edgar-von-Gierke-Straße 2
Karlsruhe, 76137
- Recruiting
Elisabeth Krankenhaus Brustzentrum
Kassel, 34117
- Recruiting
Arnold-Heller-Str. 3 Haus C
Kiel, 24105
- Recruiting
InVO - Institut für Versorgungsforschung in der Onkologie GbR / Praxis für Hämatologie und Onkologie
Koblenz, 56068
- Recruiting
Lutherplatz 40
Krefeld, 47805
- Recruiting
Fachärztezentrum Langen
Langen, 63225
- Recruiting
Liebigstraße 20
Leipzig, 04103
- Recruiting
Biedermannstrasse 84
Leipzig, 4277
- Recruiting
Universitätsklinikum Mannheim
Mannheim, 68167
- Withdrawn
Bei der Marienkirche 6
Mühlhausen, 99974
- Recruiting
Taxisstrasse 3
Munich, 80637
- Recruiting
Albert-Schweitzer-Campus 1, Building A1,
Münster, 48149
- Recruiting
Starkenburgring 66, 63069 Offenbach
Offenbach, 63069
- Recruiting
Rahel-Straus-Straße 10
Oldenburg, 26133
- Recruiting
Husenerstr. 81
Paderborn, 33098
- Recruiting
Charlottenstraße 72
Potsdam, 14467
- Recruiting
Elisabethenstr. 19, 88212 Ravensburg
Ravensburg, 88212
- Recruiting
Südring 81
Rostock, 18059
- Recruiting
Wismarsche Strasse 393-397
Schwerin, 19055
- Active, not recruiting
Harsefelderstraße 8
Stade, 21680
- Active, not recruiting
Böheimstr. 37
Stuttgart, 70199
- Recruiting
Schierghoferstrasse 1
Traunstrein, 83278
- Recruiting
Calwerstrasse 7
Tübingen, 72076
- Recruiting
Prittwitzstr. 43
Ulm, 89075
- Recruiting
Beethovenstrasse 20
Wiesbaden, 65189
- Not yet recruiting
Marienplatz 2
Witten, 58455
- Recruiting
Klinikum Worms Frauenklinik
Worms, 67550
- Recruiting
Helios University Hospital University Witten/Herdecke
Wuppertal, 42283
Spain37 sites, 36 recruiting
- Recruiting
Medical Oncology Unit. A Coruña University Hospital
A Coruña, 15006
- Recruiting
ICO Badalona - Hospital Germans Trias I Pujol
Badalona, 08916
- Recruiting
Hospital Universitary of Cruces
Barakaldo, 48903
- Recruiting
Hospital Clinic de Barcelona
Barcelona, 08036
- Recruiting
Hospital del Mar
Barcelona, 8003
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 8041
- Recruiting
Hospital Universitario San Pedro de Alcántara
Cáceres, 10003
- Recruiting
Consorcio Hospitalario Provincial de Castellón
Castellon, 12002
- Recruiting
Hospital Reina Sofia
Córdoba, 14004
- Recruiting
Hospital Donostia
Donostia / San Sebastian, 20014
- Recruiting
Hospital General Universitario De Elche
Elche, 03203
- Recruiting
Hospital Universitario de Fuenlabrada
Fuenlabrada, 28942
- Recruiting
Hospital Galdakao
Galdakao, 48960
- Recruiting
Hospital Universitario Virgen de las Nieves
Granada, 18014
- Recruiting
Hospital Universitario Clínico San Cecilio
Granada, 18016
- Recruiting
Hospital Universitario de Jaen
Jaén, 23007
- Recruiting
H. León
León, 24008
- Recruiting
Hospital Arnau de Vilanova
Lleida, 25198
- Recruiting
Hospital Beata María Ana
Madrid, 28007
- Recruiting
Hospital General Universitario Gregorio Maranon
Madrid, 28007
- Recruiting
Hospital Universitario Virgen de la Victoria
Málaga, 29010
- Recruiting
Hosp. Mat-Inf. Carlos Haya
Málaga, 29011
- Recruiting
Althaia Xarxa Assistencial de Manresa
Manresa, 08242
- Recruiting
Hospital General Univers
Murcia, 30008
- Withdrawn
Hospital Universitario Morales Meseguer
Murcia, 30008
- Recruiting
Clínica Universidad de Navarra - Madrid
Pamplona, 31008
- Recruiting
Hospital Universitari Sant Joan de Reus
Reus, 43204
- Recruiting
Hospital Parc Tauli
Sabadell, 08028
- Recruiting
Hospital Universitario de Canarias
San Cristóbal de La Laguna, 38320
- Recruiting
HU Marqués de Valdecilla
Santander, 39008
- Recruiting
Hospital Universitario Virgen Macarena
Seville, 41009
- Recruiting
Hospital Quironsalud Sagrado Corazón
Seville, 41010
- Recruiting
Hospital de Toledo
Toledo, 45007
- Recruiting
Hospital Clínico Universitario de Valencia
Valencia, 46010
- Recruiting
Hospital Clínico Universitario de Valencia
Valencia, 46014
- Recruiting
Hospital Clinico Universitario de Valladolid
Valladolid, 47003
- Recruiting
Isabel la Catolica nº 1-3
Zaragoza, 50009
Brazil20 sites, 16 recruiting
- Recruiting
St. de Habitações Individuais Sul QI 15 - Lago Sul, Brasília - DF, Brasil
Brasília, 71681-603
- Recruiting
Rua Padre Germano Mayer, 1949, Hugo Lange, Curitiba, Paraná
Curitiba, 80040-170
- Recruiting
Rua Myltho Anselmo da Silva, 870 - Mercês, Curitiba - PR, CEP 80510-130
Curitiba, 80510-130
- Recruiting
Oncosite
Ijuí, 98700-000
- Recruiting
R. Aderbal Ramos da Silva, 148 - Centro, Itajaí - SC, 88300-000, Brasil
Itajaí, 88300-000
- Recruiting
Av. Miguel Castro, 1355, Nossa Senhora de Nazaré, Natal/RN
Natal, 59062-200
- Recruiting
Rua Professor Annes Dias, 295 - Centro Histórico, Porto Alegre - RS, , Brasil
Porto Alegre, 90020-090
- Recruiting
Av. Soledad, 569, sala 1103, Três Figueiras, CEP 90470-340
Porto Alegre, 90470-340
- Recruiting
Av. Ipiranga 6690
Porto Alegre, 90610-000
- Active, not recruiting
Hospital Esperança SA
Recife, 50070-480
- Recruiting
Instituto Santa Joana Recife de Ensino e Pesquisa
Recife, 52011-906
- Recruiting
Instituto D'Or de Pesquisa e Ensino - RJ
Rio de Janiero, 20560-121
- Recruiting
Av. Milton Santos, 123 - Ondina, Salvador - BA, , Brasil
Salvador, 40170-110
- Active, not recruiting
AMO Clinic - Rio Vermelho
Salvador, 41950-640
- Active, not recruiting
Hospital Sirio Libanês - SP
São Paulo, 01308-060
- Recruiting
Av. Brigadeiro Luís Antônio 733, loja 8
São Paulo, 01317-000
- Recruiting
Martiiano de Carvalho 965
São Paulo, 01323-001
- Recruiting
CIPE Centro Internacional de Pesquisa; A.C. Camargo Cancer Center
São Paulo, 01509-010
- Active, not recruiting
Instituto D'Or de Pesquisa e Ensino SP
São Paulo, 04501-000
- Recruiting
Rua Gardênia, 710, Edifício Prime, 4º andar, Bairro Jóquei, Teresina - PI, CEP 60449-200
Teresina, 60449-200
France16 sites, 15 recruiting
- Recruiting
CHU Amiens Picardie
Amiens, 80000
- Recruiting
Pôle Santé Léonard De Vinci - ROC37
Chambray-lès-Tours, 37170
- Recruiting
Institut de Cancerologie de Bourgogne
Dijon, 21000
- Recruiting
Clinique Victor Hugo
Le Mans, 72000
- Recruiting
chu de Limoges
Limoges, 87042
- Recruiting
Institut de Cancérologie de l'Ouest (ICO) - St Herblain
Loire Atlantique, 44 805
- Recruiting
Hôpital Privé Jean Mermoz
Lyon, 69008
- Recruiting
Centre D'Oncologie de Gentilly
Nancy, 54000
- Recruiting
L'Hôpital Privé du Confluent
Nantes, 44277
- Recruiting
CHU de Nimes
Nîmes, 30029
- Recruiting
Hopital Privé des Côtes d'Armor - Centre CARIO-HPCA
Plérin, 22190
- Recruiting
CHU de Poitiers, 2 Rue de la Milétrie
Poitiers, 86021
- Recruiting
Centre Eugène Marquis
Rennes, 35042
- Active, not recruiting
Clinique Ste Anne Strasbourg_Oncologie Liberale
Strasbourg, 67000
- Recruiting
Oncopole Claudius Regaud - IUCT-O
Toulouse, 31059
- Recruiting
Gustave Roussy
Villejuif, 94800
Italy15 sites, 13 recruiting
- Recruiting
IRCCS Istituto Tumori "Giovanni Paolo II"
Bari, 70124
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
- Recruiting
Azienda Ospedaliera Universitaria Careggi
Florence, 50134
- Recruiting
IRCCS AOM Ospedale Policlinico San Martino
Genova, 16132
- Recruiting
Istituto Romagnolo Per Lo Studio Dei Tumori (IRST) 'Dino Amadori? IRCCS
Meldola, 47014
- Recruiting
Fondazione IRCCS - Istituto Nazionale dei Tumori di Milano
Milan, 20133
- Recruiting
Humanitas Istituto Clinico Catanese
Misterbianco, 95125
- Recruiting
AOU Modena
Modena, 41125
- Active, not recruiting
AOU Federico II
Naples, 80131
- Recruiting
IRCCS Fondazione G. Pascale
Naples, 80131
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 168
- Recruiting
Fondazione Policlinico Universitario Campus Bio-Medico di Roma
Rome, 00128
- Active, not recruiting
ASST Papa Giovanni XXIII
Rozzano, 20089
- Recruiting
AOU Città della Salute e della Scienza di Torino
Torino, 10123
- Recruiting
Ospedale Santa Chiara
Trento, 38122
Australia11 sites, 10 recruiting
- Recruiting
Cancer Research SA
Adelaide, South Australia, 5000
- Recruiting
Bendigo Health
Bendigo, Victoria, 3551
- Recruiting
Cairns Hospital
Cairns, Queensland, 4870
- Recruiting
Macarthur Cancer Therapy Centre, Campbelltown Hospital
Campbelltown, New South Wales, 2560
- Recruiting
Monash Medical Centre
Clayton, Victoria, 3168
- Withdrawn
Kinghorn Cancer Centre
Darlinghurst, New South Wales, 2010
- Recruiting
Townsville University Hospital
Douglass, Queensland, 4818
- Recruiting
Lake Macquarie Private Hospital
Gateshead, New South Wales, 2290
- Recruiting
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
- Recruiting
Port Macquarie Base Hospital
Port Macquarie, New South Wales, 2444
- Recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Belgium10 sites, 6 recruiting
- Active, not recruiting
Institut Jules Bordet
Anderlecht, 1070
- Active, not recruiting
AZ Klina
Brasschaat, 2930
- Recruiting
Chirec Delta Hospital
Brussels, 1160
- Active, not recruiting
Grand Hopital de Charleroi asbl (GHdC)
Gilly, 6060
- Recruiting
Jessa Ziekenhuis
Hasselt, 3500
- Recruiting
UZ Leuven
Leuven, 3000
- Recruiting
Clinique CHC MontLégia
Liège, 4000
- Recruiting
AZ Delta vzw
Roeselare, 8800
- Active, not recruiting
AZ Vitaz
Sint-Niklaas, 9100
- Recruiting
Ziekenhuls aan de Stroom vzw (ZAS vzw), ZAS Augustinus
Wilrijk, 2610
South Korea10 sites, 10 recruiting
- Recruiting
Soonchunhyang University Cheonan Hospital
Chungcheongnam-do, 31151
- Recruiting
Kyungpook National University Chilgok Hospital
Daegu, 41404
- Recruiting
Seoul National University Bundang Hospital
Gyeonggi-do, 13620
- Recruiting
Severance Hospital
Seodaemun-gu, 3722
- Recruiting
Korea University Anam Hospital
Seoul, 02841
- Recruiting
Asan Medical Center
Seoul, 05505
- Recruiting
Gangnam Severance Hospital
Seoul, 06273
- Recruiting
Seoul National University Hospital
Seoul, 3080
- Recruiting
Samsung Medical Center
Seoul, 6351
- Recruiting
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul
United Kingdom10 sites, 10 recruiting
- Recruiting
Hull University Teaching Hospitals NHS Trust
Cottingham, HU165JQ
- Not yet recruiting
University Hospitals Birmingham NHS Foundation Trust
Edgbaston, B152TH
- Recruiting
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, L7 8YA
- Recruiting
Barts Health NHS Trust
London, EC1M 6QB
- Recruiting
Guy's Hospital
London, SE1 9RT
- Recruiting
Royal Marsden Hospital
London, SW10 9NH
- Recruiting
The Christie NHS Foundation Trust
Manchester, M20 4BX
- Recruiting
East and North Hertfordshire NHS Trust
Northwood, HA6 2RN
- Recruiting
Taunton and Somerset NHS Foundation Trust
Taunton, TA1 5DA
- Not yet recruiting
York Teaching Hospital NHS Foundation Trust
York, YO31 8HE
Ireland5 sites, 5 recruiting
- Recruiting
Mater Misericordiae University Hospital
Dublin, D07 R2WY
- Recruiting
St James's Hospital
Dublin, D08NH41
- Recruiting
Beaumont Hospital
Dublin, D09V2N0
- Not yet recruiting
University Hospital Limerick
Limerick, V94 F858
- Recruiting
Cork University Hospital
Wilton, T12 DC4A
Japan2 sites, 2 recruiting
- Recruiting
Chiba Cancer Center
Chiba, 260-8717
- Recruiting
The Cancer Institute Hospital of JFCR
Tokyo, 135-8550
About this study
Official title: 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.
- Conditions
- Triple Negative Breast Cancer
- Being tested
- Sacituzumab govitecan-hziy (SG), Pembrolizumab, Capecitabine
- Keywords
- AFT-65, GBG 119, NSABP B-63, OptimICE-RD
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab govitecan-hziy (SG)Drug
Also called GS-0132, IMMU-132, Trodelvy™
Administered intravenously
PembrolizumabDrug
Also called KEYTRUDA®
Administered intravenously
CapecitabineDrug
Also called Xeloda
Tablets administered orally
| Study group | Role | What they receive |
|---|---|---|
| Sacituzumab govitecan-hziy (SG) + Pembrolizumab | Experimental | 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. Receives: Drug: Sacituzumab govitecan-hziy (SG); Drug: Pembrolizumab |
| Treatment of Physician's Choice (TPC): Pembrolizumab or Pembrolizumab + Capecitabine | Active comparator | 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. Receives: Drug: Pembrolizumab; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasive Disease-free Survival (iDFS)
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.
Measured: Up to 60 months
Secondary outcomes (6)
Overall Survival (OS)
OS is defined as the time from the date of randomization until death due to any cause.
Measured: Up to 96 months
Distant Disease-free Survival (dDFS)
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.
Measured: Up to 60 months
Recurrence-free Survival (RFS)
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.
Measured: Up to 60 months
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Measured: First dose date up to 38 months plus 30 days
Percentage of Participants Experiencing Laboratory Abnormalities
Measured: 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
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.
Measured: Up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start12 Dec 2022
- Primary completionJun 2027 (estimated)
- Study completionAug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,514 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alliance Foundation Trials, LLC., NSABP Foundation Inc, GBG Forschungs GmbH
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05633654
- Sponsor's protocol ID
- GS-US-595-6184
- Other IDs
- 2024-512279-10
- Status last verified
- Oct 2026
- First submitted
- 21 Nov 2022
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 38922307