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)

PHASE3RecruitingINTERVENTIONAL
Enrollment

1,514

Participants

Timeline

Start Date

December 12, 2022

Primary Completion Date

June 30, 2027

Study Completion Date

August 31, 2031

Conditions
Triple Negative Breast Cancer
Interventions
DRUG

Sacituzumab govitecan-hziy (SG)

Administered intravenously

DRUG

Pembrolizumab

Administered intravenously

DRUG

Capecitabine

Tablets administered orally

Trial Locations (225)

2290

RECRUITING

Lake Macquarie Private Hospital, Gateshead

2560

NOT_YET_RECRUITING

Macarthur Cancer Therapy Centre, Campbelltown Hospital, Campbelltown

3168

RECRUITING

Monash Medical Centre, Clayton

4102

RECRUITING

Princess Alexandra Hospital, Woolloongabba

8041

RECRUITING

Hospital de la Santa Creu i Sant Pau, Barcelona

10003

RECRUITING

Hospital Universitario San Pedro de Alcántara, Cáceres

10016

RECRUITING

Laura and Isaac Perlmutter Cancer Canter, New York

10467

WITHDRAWN

Montefiore Medical Center, The Bronx

10601

RECRUITING

White Plains Hospital Physician Associates, White Plains

11042

WITHDRAWN

Northwell Health, Lake Success

11590

WITHDRAWN

Clinical Research Alliance, Westbury

11794

RECRUITING

Stony Brook Medicine, Stony Brook

11967

RECRUITING

New York Cancer and Blood Specialists, Shirley

12002

RECRUITING

Consorcio Hospitalario Provincial de Castellón, Castellon

12010

WITHDRAWN

New York Oncology Hematology (NYOH), Amsterdam

13057

RECRUITING

Hematology Oncology Associates of Central New York, PC, East Syracuse

13125

ACTIVE_NOT_RECRUITING

Schwanebecker Chaussee 50, Berlin

13210

RECRUITING

SUNY Upstate Medical University, Syracuse

14263

RECRUITING

Roswell Park Cancer Institute, Buffalo

14618

RECRUITING

Lipson Cancer Institute - Linden Oaks, Rochester

15006

RECRUITING

Medical Oncology Unit. A Coruña University Hospital, A Coruña

17403

RECRUITING

Cancer Care Associates of York, York

17601

RECRUITING

Lancaster General Health, Lancaster

18014

RECRUITING

Hospital Universitario Virgen de las Nieves, Granada

18015

WITHDRAWN

Saint Luke's University Hospital, Bethlehem

18016

RECRUITING

Hospital Universitario Clínico San Cecilio, Granada

18840

RECRUITING

Guthrie Clinical Research, Sayre

19104

RECRUITING

University of Pennsylvania Abramson Cancer Center, Philadelphia

19106

RECRUITING

Lankenau Medical Center, Wynnewood

19611

WITHDRAWN

Reading Hospital and Medical Center, West Reading

20357

RECRUITING

Moorkamp 2-6, Hamburg

20817

WITHDRAWN

American Oncology Partners of Maryland, PA, Bethesda

21204

RECRUITING

Greater Baltimore Medical Center, Towson

21215

RECRUITING

Sinai Hospital of Baltimore, Inc., Baltimore

21229

RECRUITING

St. Agnes Hospital, Baltimore

21231

RECRUITING

Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center, Baltimore

21237

RECRUITING

Medstar Franklin Square Medical Center, Baltimore

21680

ACTIVE_NOT_RECRUITING

Harsefelderstraße 8, Stade

21702

RECRUITING

James M Stockman Cancer Institute, Frederick

22031

RECRUITING

Inova Fairfax Hospital, Fairfax

22190

RECRUITING

Hopital Privé des Côtes d'Armor - Centre CARIO-HPCA, Plérin

22908

RECRUITING

University of Virginia, Charlottesville

23007

RECRUITING

Hospital Universitario de Jaen, Jaén

23298

WITHDRAWN

Virginia Commonwealth University Medical Center, Richmond

24382

RECRUITING

Oncology and Hematology Associates of Southwest Virginia, Inc, Wytheville

26505

RECRUITING

West Virginia University Hospital, Morgantown

27157

RECRUITING

Atrium Health Wake Forest Baptist, Winston-Salem

27403

RECRUITING

Cone Health Medical Group (Moses Cone Health System), Greensboro

27514

RECRUITING

Lineberger Comprehensive Cancer Center, Chapel Hill

27607

RECRUITING

UNC Rex Cancer Center, Raleigh

27710

RECRUITING

Duke Cancer Institute, Durham

27804

WITHDRAWN

UNC Nash Cancer Center, Rocky Mount

27834

RECRUITING

East Carolina University Health Medical Center, Greenville

28209

RECRUITING

Hämato-Onkologische Praxis im Medicum, Bremen

28374

WITHDRAWN

FirstHealth Outpatient Cancer Center, Pinehurst

29010

RECRUITING

Hospital Universitario Virgen de la Victoria, Málaga

29303

RECRUITING

Spartanburg Medical Center, Spartanburg

29425

RECRUITING

Medical University of South Carolina, Charleston

30008

RECRUITING

Hospital Universitario Morales Meseguer, Murcia

30060

RECRUITING

Northwest Georgia Oncology Centers, PC, Marietta

30318

RECRUITING

Piedmont Cancer Institute, Atlanta

30342

RECRUITING

Northside Hospital, Atlanta

30607

RECRUITING

University Cancer & Blood Center, LLC., Athens

31008

RECRUITING

Clínica Universidad de Navarra - Madrid, Pamplona

31059

RECRUITING

Oncopole Claudius Regaud - IUCT-O, Toulouse

31602

RECRUITING

Pearlman Cancer Center, Valdosta

32224

RECRUITING

Mayo Clinic Florida, Jacksonville

32256

RECRUITING

Cancer Specialists of North Florida, Jacksonville

32504

WITHDRAWN

Sacred Heart Medical Oncology Group, Pensacola

32610

WITHDRAWN

University of Florida, Gainesville

32763

WITHDRAWN

Midland Florida Clinical Research Center, L, Orange City

32806

RECRUITING

Orlando Health, Orlando

32909

WITHDRAWN

Cancer Care Centers of Brevard, Inc, Palm Bay

33028

RECRUITING

Memorial Healthcare System, Pembroke Pines

33140

RECRUITING

Mount Sinai Comprehensive Cancer Center, Miami Beach

33324

RECRUITING

Sylvester Comprehensive Cancer Center, Plantation

33331

WITHDRAWN

Weston Hospital, Weston

33458

RECRUITING

Jupiter Medical Center, Jupiter

33604

RECRUITING

Teutoburger Str. 60, Bielefeld

33614

WITHDRAWN

St. Joseph's Hospital, Tampa

34117

RECRUITING

Elisabeth Krankenhaus Brustzentrum, Kassel

34994

WITHDRAWN

Cleveland Clinic Florida, Martin North Hospital, Stuart

35042

RECRUITING

Centre Eugène Marquis, Rennes

35243

RECRUITING

Alabama Oncology, Birmingham

35805

RECRUITING

Clearview Cancer Institute, Huntsville

37170

RECRUITING

Pôle Santé Léonard De Vinci - ROC37, Chambray-lès-Tours

37660

WITHDRAWN

Ballad Health Cancer Care - Kingsport, Kingsport

37909

WITHDRAWN

Center for Biomedical Research, LLC, Knoxville

37920

RECRUITING

University of Tennessee, Knoxville

38100

RECRUITING

Studien GbR Braunschweig, Braunschweig

39008

RECRUITING

HU Marqués de Valdecilla, Santander

40207

RECRUITING

Norton Healthcare, Inc., Louisville

40536

WITHDRAWN

University of Kentucky, Lexington

41009

RECRUITING

Hospital Universitario Virgen Macarena, Seville

41010

RECRUITING

Hospital Quironsalud Sagrado Corazón, Seville

42003

RECRUITING

Mercy Health, Paducah

42283

RECRUITING

Helios University Hospital University Witten/Herdecke, Wuppertal

43212

RECRUITING

Ohio State University CRS, Columbus

43214

RECRUITING

Ohio Health Research Institute, Columbus

43221

RECRUITING

Anita Stewart Oncology Center, Columbus

43623

NOT_YET_RECRUITING

Toledo Clinic Cancer Center, Toledo

44137

RECRUITING

St. Johannes Hospital, Dortmund

45220

RECRUITING

Good Samaritan Hospital, Cincinnati

45242

RECRUITING

Oncology Hematology Care, Inc., Cincinnati

46010

RECRUITING

Hospital Clínico Universitario de Valencia, Valencia

46236

RECRUITING

Josef-Albers-Str.70, Bottrop

46237

RECRUITING

Franciscan Health Indianapolis, Indianapolis

46260

WITHDRAWN

Investigative Clinical Research of Indiana, LLC, Indianapolis

46321

WITHDRAWN

Franciscan Health Munster, Munster

47003

RECRUITING

Hospital Clinico Universitario de Valladolid, Valladolid

47904

WITHDRAWN

IU Health Arnett Hospital, Lafayette

48073

RECRUITING

William Beaumont Hospital, Royal Oak

48075

RECRUITING

Ascension Providence Hospital Southfield Cancer Center, Southfield

48197

WITHDRAWN

Trinity Health St. Joseph Mercy Ann Arbor, Ypsilanti

48202

RECRUITING

Henry Ford Health System, Detroit

48236

WITHDRAWN

Ascension, Grosse Pointe Woods

48903

RECRUITING

Hospital Universitary of Cruces, Barakaldo

48960

RECRUITING

Hospital Galdakao, Galdakao

49124

RECRUITING

MVZ II der Niels Stensen Kliniken, Georgsmarienhütte

49503

RECRUITING

Cancer and Hematology Centers of Western Michigan, Grand Rapids

50009

RECRUITING

Isabel la Catolica nº 1-3, Zaragoza

50309

RECRUITING

Mission Cancer & Blood - John Stoddard Cancer Center, Des Moines

50935

RECRUITING

St. Elisabeth Krankenhaus GmbH, Cologne

52403

RECRUITING

Mercy Medical Center, Cedar Rapids

52556

RECRUITING

University of Iowa Hospitals and Clinics, Fairfield

53132

RECRUITING

Ascension St. Francis Reiman Cancer Center, Franklin

53792

WITHDRAWN

University of Wisconsin, Madison

54303

RECRUITING

HSHS Saint Mary's Hospital Medical Center - Green Bay, Green Bay

54911

WITHDRAWN

ThedaCare Regional Cancer Center, Appleton

55109

RECRUITING

Minnesota Oncology Hematology, PA, Maplewood

55407

RECRUITING

Virginia Piper Cancer Center (Allina Health), Minneapolis

55426

RECRUITING

Metro Minnesota Community Oncology, Saint Louis Park

55455

RECRUITING

University of Minnesota Medical Center, Fairview, Minneapolis

55905

RECRUITING

Mayo Clinic Rochester, Rochester

56068

RECRUITING

InVO - Institut für Versorgungsforschung in der Onkologie GbR / Praxis für Hämatologie und Onkologie, Koblenz

57105

RECRUITING

Avera Cancer Institute, Sioux Falls

57701

RECRUITING

Monument Health Cancer Care Institute, Rapid City

60076

WITHDRAWN

Edward H. Kaplan MD & Associates - Hematology/Oncology of the North Shore, Skokie

60201

RECRUITING

NorthShore University Healthsystem, Evanston

60305

WITHDRAWN

West Suburban Medical Center- River Forest, River Forest

60540

RECRUITING

Edward Hospital, Naperville

60611

RECRUITING

Northwestern Medicine, Chicago

60612

RECRUITING

Rush University Medical Center, Chicago

WITHDRAWN

University of Illinois, Chicago

60637

RECRUITING

University of Chicago Medical Center, Chicago

61801

RECRUITING

Carle Cancer Center, Urbana

62702

WITHDRAWN

Springfield Clinic LLP, Springfield

63131

RECRUITING

Baptist Clinical Research Institute, St Louis

63141

WITHDRAWN

Mercy Hospital, St Louis

67550

RECRUITING

Klinikum Worms Frauenklinik, Worms

68114

RECRUITING

Oncology Hematology West - Methodist, Omaha

68124

RECRUITING

Nebraska Methodist Hospital (change from Chi Health Bergan Mercy), Omaha

68167

RECRUITING

Universitätsklinikum Mannheim, Mannheim

68901

RECRUITING

Mary Lanning Healthcare - Morrison Cancer Center, Hastings

69008

RECRUITING

Hôpital Privé Jean Mermoz, Lyon

70112

WITHDRAWN

University Medical Center New Orleans, New Orleans

70199

ACTIVE_NOT_RECRUITING

Böheimstr. 37, Stuttgart

70809

RECRUITING

Mary Bird Perkins Cancer Center, Baton Rouge

72000

RECRUITING

Clinique Victor Hugo, Le Mans

72076

ACTIVE_NOT_RECRUITING

Calwerstrasse 7, Tübingen

73104

WITHDRAWN

University of Oklahoma Health Sciences Center, Oklahoma City

73730

RECRUITING

Klinikum Esslingen, Esslingen am Neckar

76137

ACTIVE_NOT_RECRUITING

Edgar-von-Gierke-Straße 2, Karlsruhe

77030

RECRUITING

MD Anderson Cancer Center, Houston

78240

RECRUITING

Texas Oncology, San Antonio

78731

RECRUITING

Texas Oncology, Austin

79410

RECRUITING

Joe Arrington Cancer Research and Treatment Center, Lubbock

79601

WITHDRAWN

Hendrick Health System, Abilene

79902

RECRUITING

Texas Oncology, El Paso

80045

WITHDRAWN

University of Colorado Cancer Center, Aurora

83712

WITHDRAWN

St Lukes Mountain States Tumor Institute, Boise

83814

RECRUITING

Kootenai Health, Coeur d'Alene

84112

RECRUITING

Huntsman Cancer Institute, Salt Lake City

85054

RECRUITING

Mayo Clinic Hospital, Phoenix

85304

RECRUITING

Palo Verde Hematology Oncology, Glendale

86150

RECRUITING

Hämatologie-Onkologie im Zentrum MVZ GmbH, Augsburg

86314

WITHDRAWN

Arizona Oncology Associates, Prescott Valley

87131

RECRUITING

University of New Mexico, Albuquerque

87401

RECRUITING

San Juan Oncology Associates, Farmington

88212

RECRUITING

Elisabethenstr. 19, 88212 Ravensburg, Ravensburg

89169

WITHDRAWN

Comprehensive Cancer Centers of Nevada, Las Vegas

89511

WITHDRAWN

Cancer Care & Hematology Specialists, Reno

90017

RECRUITING

Los Angeles Cancer Network, Los Angeles

90033

WITHDRAWN

USC Norris Comprehensive Cancer Center, Los Angeles

90048

RECRUITING

Cedars-Sinai Cancer at Beverly Hills, Los Angeles

90241

RECRUITING

PIH Health Whittier Hospital, Downey

92373

WITHDRAWN

Emad Ibrahim, MD, INC, Redlands

92663

RECRUITING

Hoag Memorial Hospital Presbyterian, Newport Beach

92708

RECRUITING

Compassionate Cancer Care Medical Group - Inc, Fountain Valley

93105

RECRUITING

Sansum Clinic, Santa Barbara

93611

WITHDRAWN

Community Cancer Institute, Clovis

94143

RECRUITING

UCSF Medical Center, San Francisco

94704

RECRUITING

Alta Bates Summit Medical Center, Berkeley

95204

RECRUITING

Stockton Hematology Oncology Medical Group, Stockton

95816

RECRUITING

Sutter Institute for Medical Research, Sacramento

97213

WITHDRAWN

Providence Cancer Institute - Oncology Clinical Trials, Portland

97239

RECRUITING

Oregon Health & Science University, Portland

97330

RECRUITING

Samaritan Hospital, Corvallis

97401

RECRUITING

Willamette Valley Cancer Institute and Research Center, Eugene

97504

WITHDRAWN

Asante Rogue Regional Medical Center, Medford

97701

RECRUITING

St. Charles Health System, Inc. DBA St. Charles Medical Center, Bend

98055

WITHDRAWN

University of Washington, Renton

98372

RECRUITING

MultiCare Regional Cancer Center - Tacoma, Puyallup

98373

RECRUITING

Northwest Medical Specialties, PLLC, Puyallup

98503

RECRUITING

Providence Regional Cancer System, Lacey

99208

WITHDRAWN

Medical Oncology Associates, Spokane

06810

WITHDRAWN

Norwalk Hospital, Danbury

06902

WITHDRAWN

Stamford Hospital, Stamford

00337

WITHDRAWN

Morton Plant Hospital - Bay Care, Clearwater

04074

RECRUITING

New England Cancer Specialists, Scarborough

02215

RECRUITING

Beth Israel Deaconess Medical Center, Boston

RECRUITING

Dana Farber Cancer Institute, Boston

01199

WITHDRAWN

Baystate Medical Center Inc., Springfield

01655

RECRUITING

University of Massachusetts Worcester, Worcester

08816

RECRUITING

Regional Cancer Care Associates LLC, East Brunswick

08822

RECRUITING

Hunterdon Medical Center, Flemington

07932

WITHDRAWN

Summit Medical Group, P.A., Florham Park

08901

RECRUITING

Rutgers Health, New Brunswick

07901

RECRUITING

Overlook Medical Center, Summit

02905

RECRUITING

Providence Health, Providence

D08NH41

RECRUITING

St James's Hospital, Dublin

08916

RECRUITING

ICO Badalona - Hospital Germans Trias I Pujol, Badalona

08036

RECRUITING

Hospital Clinic de Barcelona, Barcelona

03203

RECRUITING

Hospital General Universitario De Elche, Elche

08242

RECRUITING

Althaia Xarxa Assistencial de Manresa, Manresa

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Alliance Foundation Trials, LLC.

OTHER

collaborator

NSABP Foundation Inc

NETWORK

collaborator

GBG Forschungs GmbH

OTHER

lead

Gilead Sciences

INDUSTRY

NCT05633654 - 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) | Biotech Hunter | Biotech Hunter