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 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
2 other identifiers
interventional
1,514
11 countries
339
Brief 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 with triple negative breast cancer that still remains after surgery and pre-surgical treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2022
Longer than P75 for phase_3
339 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2022
CompletedFirst Posted
Study publicly available on registry
December 1, 2022
CompletedStudy Start
First participant enrolled
December 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2031
April 30, 2026
April 1, 2026
4.5 years
November 21, 2022
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Up to 60 months
Secondary Outcomes (6)
Overall Survival (OS)
Up to 96 months
Distant Disease-free Survival (dDFS)
Up to 60 months
Recurrence-free Survival (RFS)
Up to 60 months
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
First dose date up to 38 months plus 30 days
Percentage of Participants Experiencing Laboratory Abnormalities
First dose date up to 38 months plus 30 days
- +1 more secondary outcomes
Study Arms (2)
Sacituzumab govitecan-hziy (SG) + Pembrolizumab
EXPERIMENTALParticipants 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.
Treatment of Physician's Choice (TPC): Pembrolizumab or Pembrolizumab + Capecitabine
ACTIVE COMPARATORParticipants 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.
Interventions
Administered intravenously
Administered intravenously
Tablets administered orally
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GBG Forschungs GmbHcollaborator
- Gilead Scienceslead
- Alliance Foundation Trials, LLC.collaborator
- NSABP Foundation Inccollaborator
Study Sites (339)
Alabama Oncology
Birmingham, Alabama, 35243, United States
Clearview Cancer Institute
Huntsville, Alabama, 35805, United States
Palo Verde Hematology Oncology
Glendale, Arizona, 85304, United States
Mayo Clinic Hospital
Phoenix, Arizona, 85054, United States
Arizona Oncology Associates
Prescott Valley, Arizona, 86314, United States
Alta Bates Summit Medical Center
Berkeley, California, 94704, United States
Community Cancer Institute
Clovis, California, 93611, United States
PIH Health Whittier Hospital
Downey, California, 90241, United States
Compassionate Cancer Care Medical Group - Inc
Fountain Valley, California, 92708, United States
Los Angeles Cancer Network
Los Angeles, California, 90017, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Cedars-Sinai Cancer at Beverly Hills
Los Angeles, California, 90048, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663, United States
Emad Ibrahim, MD, INC
Redlands, California, 92373, United States
Sutter Institute for Medical Research
Sacramento, California, 95816, United States
City of Hope (Duarte)
San Francisco, California, 94143, United States
UCSF Medical Center
San Francisco, California, 94143, United States
Sansum Clinic
Santa Barbara, California, 93105, United States
Stockton Hematology Oncology Medical Group
Stockton, California, 95204, United States
University of Colorado Cancer Center
Aurora, Colorado, 80045, United States
Norwalk Hospital
Danbury, Connecticut, 06810, United States
Stamford Hospital
Stamford, Connecticut, 06902, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Morton Plant Hospital - Bay Care
Clearwater, Florida, 00337, United States
University of Florida
Gainesville, Florida, 32610, United States
Mayo Clinic Florida
Jacksonville, Florida, 32224, United States
Cancer Specialists of North Florida
Jacksonville, Florida, 32256, United States
Jupiter Medical Center
Jupiter, Florida, 33458, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140, United States
Midland Florida Clinical Research Center, L
Orange City, Florida, 32763, United States
Orlando Health
Orlando, Florida, 32806, United States
Cancer Care Centers of Brevard, Inc
Palm Bay, Florida, 32909, United States
Memorial Healthcare System
Pembroke Pines, Florida, 33028, United States
Sacred Heart Medical Oncology Group
Pensacola, Florida, 32504, United States
Sylvester Comprehensive Cancer Center
Plantation, Florida, 33324, United States
Cleveland Clinic Florida, Martin North Hospital
Stuart, Florida, 34994, United States
St. Joseph's Hospital
Tampa, Florida, 33614, United States
Weston Hospital
Weston, Florida, 33331, United States
University Cancer & Blood Center, LLC.
Athens, Georgia, 30607, United States
Piedmont Cancer Institute
Atlanta, Georgia, 30318, United States
Northside Hospital
Atlanta, Georgia, 30342, United States
Northwest Georgia Oncology Centers, PC
Marietta, Georgia, 30060, United States
Southeastern Regional Medical Center, Inc. dba City of Hope Atlanta
Newnan, Georgia, 30265, United States
Pearlman Cancer Center
Valdosta, Georgia, 31602, United States
St Lukes Mountain States Tumor Institute
Boise, Idaho, 83712, United States
Kootenai Health
Coeur d'Alene, Idaho, 83814, United States
Northwestern Medicine
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Illinois
Chicago, Illinois, 60612, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
NorthShore University Healthsystem
Evanston, Illinois, 60201, United States
Edward Hospital
Naperville, Illinois, 60540, United States
West Suburban Medical Center- River Forest
River Forest, Illinois, 60305, United States
Edward H. Kaplan MD & Associates - Hematology/Oncology of the North Shore
Skokie, Illinois, 60076, United States
Springfield Clinic LLP
Springfield, Illinois, 62702, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
Franciscan Health Indianapolis
Indianapolis, Indiana, 46237, United States
Investigative Clinical Research of Indiana, LLC
Indianapolis, Indiana, 46260, United States
IU Health Arnett Hospital
Lafayette, Indiana, 47904, United States
Franciscan Health Munster
Munster, Indiana, 46321, United States
Mercy Medical Center
Cedar Rapids, Iowa, 52403, United States
Mission Cancer & Blood - John Stoddard Cancer Center
Des Moines, Iowa, 50309, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Norton Healthcare, Inc.
Louisville, Kentucky, 40207, United States
Mercy Health
Paducah, Kentucky, 42003, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809, United States
University Medical Center New Orleans
New Orleans, Louisiana, 70112, United States
New England Cancer Specialists
Scarborough, Maine, 04074, United States
Sinai Hospital of Baltimore, Inc.
Baltimore, Maryland, 21215, United States
St. Agnes Hospital
Baltimore, Maryland, 21229, United States
Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231, United States
American Oncology Partners of Maryland, PA
Bethesda, Maryland, 20817, United States
James M Stockman Cancer Institute
Frederick, Maryland, 21702, United States
Greater Baltimore Medical Center
Towson, Maryland, 21204, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Massachusetts General Hospital
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute @Foxborough
Foxborough, Massachusetts, 02035, United States
Dana-Farber Cancer Institude at Merrimack Valley
Methuen, Massachusetts, 01844, United States
Dana Farber Cancer Institute @ Milford Regional Hospital
Milford, Massachusetts, 01757, United States
Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) in Clinical Affiliation with South Shore Hospital
South Weymouth, Massachusetts, 02190, United States
Baystate Medical Center Inc.
Springfield, Massachusetts, 01199, United States
University of Massachusetts Worcester
Worcester, Massachusetts, 01655, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49503, United States
Ascension
Grosse Pointe Woods, Michigan, 48236, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Ascension Providence Hospital Southfield Cancer Center
Southfield, Michigan, 48075, United States
Trinity Health St. Joseph Mercy Ann Arbor
Ypsilanti, Michigan, 48197, United States
Minnesota Oncology Hematology, PA
Maplewood, Minnesota, 55109, United States
Virginia Piper Cancer Center (Allina Health)
Minneapolis, Minnesota, 55407, United States
University of Minnesota Medical Center, Fairview
Minneapolis, Minnesota, 55455, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Metro Minnesota Community Oncology
Saint Louis Park, Minnesota, 55426, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Baptist Clinical Research Institute
St Louis, Missouri, 63131, United States
Mercy Hospital
St Louis, Missouri, 63141, United States
Mary Lanning Healthcare - Morrison Cancer Center
Hastings, Nebraska, 68901, United States
Oncology Hematology West - Methodist
Omaha, Nebraska, 68114, United States
Nebraska Methodist Hospital (change from Chi Health Bergan Mercy)
Omaha, Nebraska, 68124, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169, United States
Cancer Care & Hematology Specialists
Reno, Nevada, 89511, United States
Regional Cancer Care Associates LLC
East Brunswick, New Jersey, 08816, United States
Hunterdon Medical Center
Flemington, New Jersey, 08822, United States
Summit Medical Group, P.A.
Florham Park, New Jersey, 07932, United States
Rutgers Health
New Brunswick, New Jersey, 08901, United States
Overlook Medical Center
Summit, New Jersey, 07901, United States
University of New Mexico
Albuquerque, New Mexico, 87131, United States
San Juan Oncology Associates
Farmington, New Mexico, 87401, United States
New York Oncology Hematology (NYOH)
Amsterdam, New York, 12010, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Hematology Oncology Associates of Central New York, PC
East Syracuse, New York, 13057, United States
Northwell Health
Lake Success, New York, 11042, United States
Laura and Isaac Perlmutter Cancer Canter
New York, New York, 10016, United States
Lipson Cancer Institute - Linden Oaks
Rochester, New York, 14618, United States
New York Cancer and Blood Specialists
Shirley, New York, 11967, United States
Stony Brook Medicine
Stony Brook, New York, 11794, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Clinical Research Alliance
Westbury, New York, 11590, United States
White Plains Hospital Physician Associates
White Plains, New York, 10601, United States
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27514, United States
Duke Cancer Institute
Durham, North Carolina, 27710, United States
Cone Health Medical Group (Moses Cone Health System)
Greensboro, North Carolina, 27403, United States
East Carolina University Health Medical Center
Greenville, North Carolina, 27834, United States
FirstHealth Outpatient Cancer Center
Pinehurst, North Carolina, 28374, United States
UNC Rex Cancer Center
Raleigh, North Carolina, 27607, United States
UNC Nash Cancer Center
Rocky Mount, North Carolina, 27804, United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157, United States
Good Samaritan Hospital
Cincinnati, Ohio, 45220, United States
Oncology Hematology Care, Inc.
Cincinnati, Ohio, 45242, United States
Ohio State University CRS
Columbus, Ohio, 43212, United States
Ohio Health Research Institute
Columbus, Ohio, 43214, United States
Columbus NCORP
Columbus, Ohio, 43215, United States
Anita Stewart Oncology Center
Columbus, Ohio, 43221, United States
Toledo Clinic Cancer Center
Toledo, Ohio, 43623, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
St. Charles Health System, Inc. DBA St. Charles Medical Center
Bend, Oregon, 97701, United States
Samaritan Hospital
Corvallis, Oregon, 97330, United States
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, 97401, United States
Asante Rogue Regional Medical Center
Medford, Oregon, 97504, United States
Providence Cancer Institute - Oncology Clinical Trials
Portland, Oregon, 97213, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Saint Luke's University Hospital
Bethlehem, Pennsylvania, 18015, United States
Lancaster General Health
Lancaster, Pennsylvania, 17601, United States
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
UPMC Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213, United States
Guthrie Clinical Research
Sayre, Pennsylvania, 18840, United States
Reading Hospital and Medical Center
West Reading, Pennsylvania, 19611, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, 19106, United States
Cancer Care Associates of York
York, Pennsylvania, 17403, United States
Providence Health
Providence, Rhode Island, 02905, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
Monument Health Cancer Care Institute
Rapid City, South Dakota, 57701, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
Ballad Health Cancer Care - Kingsport
Kingsport, Tennessee, 37660, United States
Center for Biomedical Research, LLC
Knoxville, Tennessee, 37909, United States
University of Tennessee
Knoxville, Tennessee, 37920, United States
Hendrick Health System
Abilene, Texas, 79601, United States
Texas Oncology
Austin, Texas, 78731, United States
Texas Oncology
El Paso, Texas, 79902, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410, United States
Texas Oncology
San Antonio, Texas, 78240, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Inova Fairfax Hospital
Fairfax, Virginia, 22031, United States
Bon Secours Cancer Institute at St. Francis
Midlothian, Virginia, 23114, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298, United States
Oncology and Hematology Associates of Southwest Virginia, Inc
Wytheville, Virginia, 24382, United States
Providence Regional Cancer System
Lacey, Washington, 98503, United States
MultiCare Regional Cancer Center - Tacoma
Puyallup, Washington, 98372, United States
Northwest Medical Specialties, PLLC
Puyallup, Washington, 98373, United States
University of Washington
Renton, Washington, 98055, United States
Medical Oncology Associates
Spokane, Washington, 99208, United States
West Virginia University Hospital
Morgantown, West Virginia, 26505, United States
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911, United States
Ascension St. Francis Reiman Cancer Center
Franklin, Wisconsin, 53132, United States
HSHS Saint Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, 54303, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Macarthur Cancer Therapy Centre, Campbelltown Hospital
Campbelltown, New South Wales, 2560, Australia
Kinghorn Cancer Centre
Darlinghurst, New South Wales, 2010, Australia
Lake Macquarie Private Hospital
Gateshead, New South Wales, 2290, Australia
Port Macquarie Base Hospital
Port Macquarie, New South Wales, 2444, Australia
Cairns Hospital
Cairns, Queensland, 4870, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Cancer Research SA
Adelaide, South Australia, 5000, Australia
Bendigo Health
Bendigo, Victoria, 3551, Australia
Monash Medical Centre
Clayton, Victoria, 3168, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
Chirec Delta Hospital
Brussels, 1160, Belgium
UZ Leuven
Leuven, 3000, Belgium
AZ Delta vzw
Roeselare, 8800, Belgium
Ziekenhuls aan de Stroom vzw (ZAS vzw), ZAS Augustinus
Wilrijk, 2610, Belgium
St. de Habitações Individuais Sul QI 15 - Lago Sul, Brasília - DF, Brasil
Brasília, 71681-603, Brazil
Rua Myltho Anselmo da Silva, 870 - Mercês, Curitiba - PR, CEP 80510-130
Curitiba, 80510-130, Brazil
R. Aderbal Ramos da Silva, 148 - Centro, Itajaí - SC, 88300-000, Brasil
Itajaí, 88300-000, Brazil
Av. Miguel Castro, 1355, Nossa Senhora de Nazaré, Natal/RN
Natal, 59062-200, Brazil
Rua Professor Annes Dias, 295 - Centro Histórico, Porto Alegre - RS, , Brasil
Porto Alegre, 90020-090, Brazil
Av. Soledad, 569, sala 1103, Três Figueiras, CEP 90470-340
Porto Alegre, 90470-340, Brazil
Av. Ipiranga 6690
Porto Alegre, 90610-000, Brazil
Av. Milton Santos, 123 - Ondina, Salvador - BA, , Brasil
Salvador, 40170-110, Brazil
Av. Brigadeiro Luís Antônio 733, loja 8
São Paulo, 01317-000, Brazil
Martiiano de Carvalho 965
São Paulo, 01323-001, Brazil
CIPE Centro Internacional de Pesquisa; A.C. Camargo Cancer Center
São Paulo, 01509-010, Brazil
Rua Gardênia, 710, Edifício Prime, 4º andar, Bairro Jóquei, Teresina - PI, CEP 60449-200
Teresina, 60449-200, Brazil
CHU Amiens Picardie
Amiens, 80000, France
Pôle Santé Léonard De Vinci - ROC37
Chambray-lès-Tours, 37170, France
Clinique Victor Hugo
Le Mans, 72000, France
chu de Limoges
Limoges, 87042, France
Institut de Cancérologie de l'Ouest (ICO) - St Herblain
Loire Atlantique, 44 805, France
Hôpital Privé Jean Mermoz
Lyon, 69008, France
Centre D'Oncologie de Gentilly
Nancy, 54000, France
L'Hôpital Privé du Confluent
Nantes, 44277, France
CHU de Nimes
Nîmes, 30029, France
Hopital Privé des Côtes d'Armor - Centre CARIO-HPCA
Plérin, 22190, France
CHU de Poitiers, 2 Rue de la Milétrie
Poitiers, 86021, France
Centre Eugène Marquis
Rennes, 35042, France
Oncopole Claudius Regaud - IUCT-O
Toulouse, 31059, France
Hämatologie-Onkologie im Zentrum MVZ GmbH
Augsburg, 86150, Germany
Schwanebecker Chaussee 50
Berlin, 13125, Germany
Möllendorffstr. 52, 10367 Berlin 2. Behandlungsstandort: Markt 2-3, 13597 Berlin
Berlin, 13597, Germany
Teutoburger Str. 60
Bielefeld, 33604, Germany
Josef-Albers-Str.70
Bottrop, 46236, Germany
Studien GbR Braunschweig
Braunschweig, 38100, Germany
St.-Juergen-Str. 1
Bremen, 28205, Germany
Hämato-Onkologische Praxis im Medicum
Bremen, 28209, Germany
St. Elisabeth Krankenhaus GmbH
Cologne, 50935, Germany
St. Johannes Hospital
Dortmund, 44137, Germany
Fetscherstraße ,74
Dresden, 01307, Germany
Kostara Gyn. Oncology Clinic Research UG
Düsseldorf, 40235, Germany
Universitätsstraße, 21-23
Erlangen, 91054, Germany
Henricistraße 92, 45136 Essen, Germany
Essen, 45136, Germany
Klinikum Esslingen
Esslingen am Neckar, 73730, Germany
Wilhelm-Epstein-Str. 4
Frankfurt, 60431, Germany
Gotenstraße 6-8
Frankfurt am Main, 65929, Germany
Hugstetter Str. 55
Freiburg im Breisgau, 79106, Germany
Munckelstrasse 27
Gelsenkirchen, 45879, Germany
MVZ II der Niels Stensen Kliniken
Georgsmarienhütte, 49124, Germany
Straße des Friedens 122
Gera, 7548, Germany
Hohe Weide 17b
Hamburg, 20259, Germany
Moorkamp 2-6
Hamburg, 20357, Germany
Am Klinikum 1
Jena, 07447, Germany
Edgar-von-Gierke-Straße 2
Karlsruhe, 76137, Germany
Elisabeth Krankenhaus Brustzentrum
Kassel, 34117, Germany
Arnold-Heller-Str. 3 Haus C
Kiel, 24105, Germany
InVO - Institut für Versorgungsforschung in der Onkologie GbR / Praxis für Hämatologie und Onkologie
Koblenz, 56068, Germany
Fachärztezentrum Langen
Langen, 63225, Germany
Liebigstraße 20
Leipzig, 04103, Germany
Biedermannstrasse 84
Leipzig, 4277, Germany
Universitätsklinikum Mannheim
Mannheim, 68167, Germany
Taxisstrasse 3
Munich, 80637, Germany
Bei der Marienkirche 6
Mühlhausen, 99974, Germany
Albert-Schweitzer-Campus 1, Building A1,
Münster, 48149, Germany
Starkenburgring 66, 63069 Offenbach
Offenbach, 63069, Germany
Husenerstr. 81
Paderborn, 33098, Germany
Charlottenstraße 72
Potsdam, 14467, Germany
Elisabethenstr. 19, 88212 Ravensburg
Ravensburg, 88212, Germany
Südring 81
Rostock, 18059, Germany
Harsefelderstraße 8
Stade, 21680, Germany
Böheimstr. 37
Stuttgart, 70199, Germany
Schierghoferstrasse 1
Traunstrein, 83278, Germany
Calwerstrasse 7
Tübingen, 72076, Germany
Prittwitzstr. 43
Ulm, 89075, Germany
Beethovenstrasse 20
Wiesbaden, 65189, Germany
Klinikum Worms Frauenklinik
Worms, 67550, Germany
Helios University Hospital University Witten/Herdecke
Wuppertal, 42283, Germany
Mater Misericordiae University Hospital
Dublin, D07 R2WY, Ireland
St James's Hospital
Dublin, D08NH41, Ireland
Beaumont Hospital
Dublin, D09V2N0, Ireland
University Hospital Limerick
Limerick, V94 F858, Ireland
Cork University Hospital
Wilton, T12 DC4A, Ireland
IRCCS Istituto Tumori "Giovanni Paolo II"
Bari, 70124, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, 50134, Italy
Humanitas Istituto Clinico Catanese
Misterbianco, 95125, Italy
AOU Modena
Modena, 41125, Italy
IRCCS Fondazione G. Pascale
Naples, 80131, Italy
Istituto Romagnolo Per Lo Studio Dei Tumori (IRST) 'Dino Amadori? IRCCS
Parma, 43100, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 168, Italy
Fondazione Policlinico Universitario Campus Bio-Medico di Roma
Rome, 00128, Italy
AOU Città della Salute e della Scienza di Torino
Torino, 10123, Italy
Ospedale Santa Chiara
Trento, 38122, Italy
Soonchunhyang University Cheonan Hospital
Chungcheongnam-do, 31151, South Korea
Kyungpook National University Chilgok Hospital
Daegu, 41404, South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, 13620, South Korea
Severance Hospital
Seodaemun-gu, 3722, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Gangnam Severance Hospital
Seoul, 06273, South Korea
Seoul National University Hospital
Seoul, 3080, South Korea
Samsung Medical Center
Seoul, 6351, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea
Medical Oncology Unit. A Coruña University Hospital
A Coruña, 15006, Spain
ICO Badalona - Hospital Germans Trias I Pujol
Badalona, 08916, Spain
Hospital Universitary of Cruces
Barakaldo, 48903, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital del Mar
Barcelona, 8003, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 8041, Spain
Consorcio Hospitalario Provincial de Castellón
Castellon, 12002, Spain
Hospital Universitario San Pedro de Alcántara
Cáceres, 10003, Spain
Hospital Reina Sofia
Córdoba, 14004, Spain
Hospital Donostia
Donostia / San Sebastian, 20014, Spain
Hospital General Universitario De Elche
Elche, 03203, Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada, 28942, Spain
Hospital Galdakao
Galdakao, 48960, Spain
Hospital Universitario Virgen de las Nieves
Granada, 18014, Spain
Hospital Universitario Clínico San Cecilio
Granada, 18016, Spain
Hospital Universitario de Jaen
Jaén, 23007, Spain
H. León
León, 24008, Spain
Hospital Arnau de Vilanova
Lleida, 25198, Spain
Hospital Beata María Ana
Madrid, 28007, Spain
Hospital General Universitario Gregorio Maranon
Madrid, 28007, Spain
Althaia Xarxa Assistencial de Manresa
Manresa, 08242, Spain
Hospital Universitario Virgen de la Victoria
Málaga, 29010, Spain
Hosp. Mat-Inf. Carlos Haya
Málaga, 29011, Spain
Hospital General Univers
Murcia, 30008, Spain
Hospital Universitario Morales Meseguer
Murcia, 30008, Spain
Clínica Universidad de Navarra - Madrid
Pamplona, 31008, Spain
Hospital Universitari Sant Joan de Reus
Reus, 43204, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, 38320, Spain
HU Marqués de Valdecilla
Santander, 39008, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Hospital Quironsalud Sagrado Corazón
Seville, 41010, Spain
Hospital de Toledo
Toledo, 45007, Spain
Hospital Clínico Universitario de Valencia
Valencia, 46010, Spain
Hospital Clínico Universitario de Valencia
Valencia, 46014, Spain
Hospital Clinico Universitario de Valladolid
Valladolid, 47003, Spain
Isabel la Catolica nº 1-3
Zaragoza, 50009, Spain
Hull University Teaching Hospitals NHS Trust
Cottingham, HU165JQ, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, L7 8YA, United Kingdom
Barts Health NHS Trust
London, EC1M 6QB, United Kingdom
Royal Marsden Hospital
London, SW10 9NH, United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Taunton and Somerset NHS Foundation Trust
Taunton, TA1 5DA, United Kingdom
Related Publications (1)
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.
PMID: 38922307DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Central Study Contacts
Gilead Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2022
First Posted
December 1, 2022
Study Start
December 12, 2022
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
August 1, 2031
Last Updated
April 30, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share