Taking people in United StatesPhase 3
Tests a drug combination after surgery for triple negative breast cancer
Tests sacituzumab govitecan with pembrolizumab in adults with triple negative breast cancer left after surgery.
Plain-language title generated from the registry record
Registry title: 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)
Key facts
- Where
- Abilene, Albuquerque, Amsterdam, Appleton, Athens, Atlanta, Aurora, Austin, Baltimore, Baton Rouge, Bend, Berkeley, Bethesda, Bethlehem, Birmingham, Boise, Boston, Buffalo, Cedar Rapids, Chapel Hill, Charleston, Charlotte, Charlottesville, Chicago, Cincinnati, Clearwater, Clovis, Coeur d'Alene, Columbus, Corvallis, Danbury, Des Moines, Detroit, Downey, Durham, East Brunswick, East Syracuse, El Paso, Eugene, Evanston, Fairfax, Farmington, Flemington, Florham Park, Fountain Valley, Foxborough, Franklin, Frederick, Gainesville, Glendale, Grand Rapids, Green Bay, Greensboro, Greenville, Grosse Pointe Woods, Hastings, Houston, Huntsville, Indianapolis, Iowa City, Jacksonville, Jupiter, Kingsport, Knoxville, Lacey, Lafayette, Lake Success, Lancaster, Las Vegas, Lexington, Los Angeles, Louisville, Lubbock, Madison, Maplewood, Marietta, Medford, Methuen, Miami Beach, Midlothian, Milford, Minneapolis, Morgantown, Munster, Naperville, New Brunswick, New Orleans, New York, Newnan, Newport Beach, Oklahoma City, Omaha, Orange City, Orlando, Paducah, Palm Bay, Pembroke Pines, Pensacola, Philadelphia, Phoenix, Pinehurst, Pittsburgh, Plantation, Portland, Prescott Valley, Providence, Puyallup, Raleigh, Rapid City, Redlands, Reno, Renton, Richmond, River Forest, Rochester, Rocky Mount, Royal Oak, Sacramento, Saint Louis Park, Salt Lake City, San Antonio, San Francisco, Santa Barbara, Sayre, Scarborough, Shirley, Sioux Falls, Skokie, South Weymouth, Southfield, Spartanburg, Spokane, Springfield, St Louis, Stamford, Stockton, Stony Brook, Stuart, Summit, Syracuse, Tampa, The Bronx, Toledo, Towson, Urbana, Valdosta, Washington D.C., West Reading, Westbury, Weston, White Plains, Wichita, Winston-Salem, Worcester, Wynnewood, Wytheville, York, and Ypsilanti, United StatesSee the 187 sites
- Phase
- Phase 3
Where in United States
- Hendrick Health SystemAbilene, United StatesNo longer taking part
- University of New MexicoAlbuquerque, United StatesTaking people
- New York Oncology Hematology (NYOH)Amsterdam, United StatesNo longer taking part
- ThedaCare Regional Cancer CenterAppleton, United StatesNo longer taking part
- University Cancer & Blood Center, LLCAthens, United StatesTaking people
- Northside HospitalAtlanta, United StatesTaking people
- Piedmont Cancer InstituteAtlanta, United StatesTaking people
- University of Colorado Cancer CenterAurora, United StatesNo longer taking part
- Texas OncologyAustin, United StatesTaking people
- Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer CenterBaltimore, United StatesTaking people
- Sinai Hospital of Baltimore, Inc.Baltimore, United StatesTaking people
- St. Agnes HospitalBaltimore, United StatesTaking people
- Mary Bird Perkins Cancer CenterBaton Rouge, United StatesTaking people
- St. Charles Health System, Inc. DBA St. Charles Medical CenterBend, United StatesTaking people
- Alta Bates Summit Medical CenterBerkeley, United StatesTaking people
- American Oncology Partners of Maryland, PABethesda, United StatesNo longer taking part
- Saint Luke's University HospitalBethlehem, United StatesNo longer taking part
- Alabama OncologyBirmingham, United StatesTaking people
- St Lukes Mountain States Tumor InstituteBoise, United StatesNo longer taking part
- Beth Israel Deaconess Medical CenterBoston, United StatesTaking people
- Dana-Farber Cancer InstituteBoston, United StatesTaking people
- Massachusetts General HospitalBoston, United StatesTaking people
- Tufts Medical CenterBoston, United StatesTaking people
- Roswell Park Cancer InstituteBuffalo, United StatesNo longer taking part
- Mercy Medical CenterCedar Rapids, United StatesNo longer taking part
- Lineberger Comprehensive Cancer CenterChapel Hill, United StatesTaking people
- Medical University of South CarolinaCharleston, United StatesTaking people
- Novant Health Cancer Institute - Elizabeth (Breast)Charlotte, United StatesTaking people
- University of VirginiaCharlottesville, United StatesTaking people
- Northwestern MedicineChicago, United StatesTaking people
- Rush University Medical CenterChicago, United StatesTaking people
- University of Chicago Medical CenterChicago, United StatesTaking people
- University of IllinoisChicago, United StatesNo longer taking part
- Good Samaritan HospitalCincinnati, United StatesTaking people
- Oncology Hematology Care, IncCincinnati, United StatesTaking people
- Morton Plant Hospital - Bay CareClearwater, United StatesNo longer taking part
- Community Cancer InstituteClovis, United StatesNo longer taking part
- Kootenai HealthCoeur d'Alene, United StatesTaking people
- Anita Stewart Oncology CenterColumbus, United StatesTaking people
- Ohio Health Research InstituteColumbus, United StatesTaking people
- Ohio State University CRSColumbus, United StatesTaking people
- Columbus NCORPColumbus, United StatesNo longer taking part
- Samaritan HospitalCorvallis, United StatesTaking people
- Norwalk HospitalDanbury, United StatesNo longer taking part
- Mission Cancer & Blood - John Stoddard Cancer CenterDes Moines, United StatesTaking people
- Henry Ford Health SystemDetroit, United StatesNo longer taking part
- PIH Health Whittier HospitalDowney, United StatesTaking people
- Duke Cancer InstituteDurham, United StatesTaking people
- Regional Cancer Care Associates LLCEast Brunswick, United StatesTaking people
- Hematology-Oncology Associates of Central New York, PCEast Syracuse, United StatesTaking people
- Texas OncologyEl Paso, United StatesTaking people
- Willamette Valley Cancer Institute and Research CenterEugene, United StatesTaking people
- NorthShore University HealthSystemEvanston, United StatesTaking people
- Inova Fairfax HospitalFairfax, United StatesTaking people
- San Juan Oncology AssociatesFarmington, United StatesTaking people
- Hunterdon Medical CenterFlemington, United StatesTaking people
- Summit Medical Group, P.A.Florham Park, United StatesNo longer taking part
- Compassionate Cancer Care Medical Group, IncFountain Valley, United StatesNo longer taking part
- Dana Farber Cancer Institute - FoxboroughFoxborough, United StatesTaking people
- Ascension St. Francis Reiman Cancer CenterFranklin, United StatesTaking people
- James M Stockman Cancer InstituteFrederick, United StatesTaking people
- University of FloridaGainesville, United StatesNo longer taking part
- Palo Verde Hematology OncologyGlendale, United StatesTaking people
- Cancer and Hematology Centers of Western MichiganGrand Rapids, United StatesTaking people
- HSHS Saint Mary's Hospital Medical Center - Green BayGreen Bay, United StatesNo longer taking part
- Cone Health Medical Group (Moses Cone Health System)Greensboro, United StatesTaking people
- St Francis Cancer CenterGreenville, United StatesTaking people
- East Carolina University Health Medical CenterGreenville, United StatesNo longer taking part
- AscensionGrosse Pointe Woods, United StatesNo longer taking part
- Mary Lanning Healthcare, Morrison Cancer CenterHastings, United StatesNo longer taking part
- MD Anderson Cancer CenterHouston, United StatesTaking people
- Clearview Cancer InstituteHuntsville, United StatesTaking people
- Franciscan Health IndianapolisIndianapolis, United StatesTaking people
- Investigative Clinical Research of Indiana, LLCIndianapolis, United StatesNo longer taking part
- University of Iowa Hospitals and ClinicsIowa City, United StatesTaking people
- Cancer Specialists of North FloridaJacksonville, United StatesTaking people
- Mayo Clinic FloridaJacksonville, United StatesTaking people
- Jupiter Medical CenterJupiter, United StatesTaking people
- Ballad Health Cancer Care - KingsportKingsport, United StatesNo longer taking part
- University of TennesseeKnoxville, United StatesTaking people
- Center for Biomedical Research, LLCKnoxville, United StatesNo longer taking part
- Providence Regional Cancer SystemLacey, United StatesTaking people
- IU Health Arnett HospitalLafayette, United StatesNo longer taking part
- Northwell HealthLake Success, United StatesTaking people
- Lancaster General HealthLancaster, United StatesTaking people
- Comprehensive Cancer Centers of NevadaLas Vegas, United StatesNo longer taking part
- University of KentuckyLexington, United StatesNo longer taking part
- Cedars-Sinai Cancer at Beverly HillsLos Angeles, United StatesTaking people
- Los Angeles Cancer NetworkLos Angeles, United StatesNo longer taking part
- USC / Norris Comprehensive Cancer CenterLos Angeles, United StatesNo longer taking part
- Norton Healthcare, Inc.Louisville, United StatesTaking people
- Joe Arrington Cancer Research and Treatment CenterLubbock, United StatesNo longer taking part
- University of WisconsinMadison, United StatesNo longer taking part
- Minnesota Oncology Hematology PAMaplewood, United StatesTaking people
- Northwest Georgia Oncology Centers PCMarietta, United StatesTaking people
- Asante Rogue Regional Medical CenterMedford, United StatesNo longer taking part
- Dana-Farber Cancer Institude at Merrimack ValleyMethuen, United StatesTaking people
- Mount Sinai Comprehensive Cancer CenterMiami Beach, United StatesTaking people
- Bon Secours Cancer Institute at St. FrancisMidlothian, United StatesTaking people
- Dana Farber Cancer Institute @ Milford Regional HospitalMilford, United StatesTaking people
- University of Minnesota Medical Center, FairviewMinneapolis, United StatesTaking people
- Virginia Piper Cancer Center (Allina Health)Minneapolis, United StatesTaking people
- West Virginia University HospitalMorgantown, United StatesTaking people
- Franciscan Health MunsterMunster, United StatesNo longer taking part
- Edward HospitalNaperville, United StatesTaking people
- Rutgers HealthNew Brunswick, United StatesTaking people
- University Medical Center New OrleansNew Orleans, United StatesNo longer taking part
- Laura and Isaac Perlmutter Cancer CanterNew York, United StatesTaking people
- Southeastern Regional Medical Center, Inc. dba City of Hope AtlantaNewnan, United StatesTaking people
- Hoag Memorial Hospital PresbyterianNewport Beach, United StatesTaking people
- University of Oklahoma Health Sciences CenterOklahoma City, United StatesNo longer taking part
- Nebraska Methodist Hospital (change from Chi Health Bergan Mercy)Omaha, United StatesTaking people
- Oncology Hematology West - MethodistOmaha, United StatesTaking people
- Midland Florida Clinical Research Center, LOrange City, United StatesNo longer taking part
- Orlando HealthOrlando, United StatesNo longer taking part
- Mercy HealthPaducah, United StatesTaking people
- Cancer Care Centers of Brevard, Inc.Palm Bay, United StatesTaking people
- Memorial Healthcare SystemPembroke Pines, United StatesTaking people
- Sacred Heart Medical Oncology GroupPensacola, United StatesNo longer taking part
- University of Pennsylvania/Abramson Cancer CenterPhiladelphia, United StatesTaking people
- Mayo Clinic HospitalPhoenix, United StatesNo longer taking part
- FirstHealth Outpatient Cancer CenterPinehurst, United StatesNo longer taking part
- UPMC-Magee Womens HospitalPittsburgh, United StatesTaking people
- Sylvester Comprehensive Cancer CenterPlantation, United StatesTaking people
- Oregon Health Science UniversityPortland, United StatesTaking people
- Providence Cancer Institute - Oncology Clinical TrialsPortland, United StatesNo longer taking part
- Arizona Oncology AssociatesPrescott Valley, United StatesNo longer taking part
- Providence HealthProvidence, United StatesTaking people
- MultiCare Regional Cancer Center - TacomaPuyallup, United StatesTaking people
- NorthWest Medical Specialties, PLLCPuyallup, United StatesTaking people
- UNC Rex Cancer CenterRaleigh, United StatesNo longer taking part
- Monument Health Cancer Care InstituteRapid City, United StatesTaking people
- Emad Ibrahim, MD, Inc.Redlands, United StatesNo longer taking part
- Cancer Care & Hematology SpecialistsReno, United StatesNo longer taking part
- University of WashingtonRenton, United StatesNo longer taking part
- Virginia Commonwealth University Medical CenterRichmond, United StatesNo longer taking part
- West Suburban Medical Center- River ForestRiver Forest, United StatesNo longer taking part
- Lipson Cancer Institute - Linden OaksRochester, United StatesTaking people
- Mayo Clinic - RochesterRochester, United StatesTaking people
- UNC Nash Cancer CenterRocky Mount, United StatesNo longer taking part
- William Beaumont HospitalRoyal Oak, United StatesTaking people
- Sutter Institute for Medical ResearchSacramento, United StatesTaking people
- Metro Minnesota Community OncologySaint Louis Park, United StatesTaking people
- Huntsman Cancer InstituteSalt Lake City, United StatesTaking people
- Texas OncologySan Antonio, United StatesTaking people
- City of Hope (Duarte)San Francisco, United StatesTaking people
- UCSF Medical CenterSan Francisco, United StatesTaking people
- Sansum ClinicSanta Barbara, United StatesTaking people
- Guthrie Clinical ResearchSayre, United StatesTaking people
- New England Cancer SpecialistsScarborough, United StatesTaking people
- New York Cancer and Blood SpecialistsShirley, United StatesTaking people
- Avera Cancer InstituteSioux Falls, United StatesTaking people
- Edward H. Kaplan MD & Associates - Hematology/Oncology of the North ShoreSkokie, United StatesNo longer taking part
- Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) in clinical affiliation with South Shore HospitalSouth Weymouth, United StatesTaking people
- Ascension Providence Hospital Southfield Cancer CenterSouthfield, United StatesNo longer taking part
- Spartanburg Medical CenterSpartanburg, United StatesTaking people
- Medical Oncology AssociatesSpokane, United StatesNo longer taking part
- Baystate Medical Center Inc.Springfield, United StatesNo longer taking part
- Springfield Clinic, LLPSpringfield, United StatesNo longer taking part
- Washington University School of MedicineSt Louis, United StatesTaking people
- Baptist Clinical Research InstituteSt Louis, United StatesNo longer taking part
- Mercy HospitalSt Louis, United StatesNo longer taking part
- Stamford HospitalStamford, United StatesTaking people
- Stockton Hematology Oncology Medical GroupStockton, United StatesTaking people
- Stony Brook MedicineStony Brook, United StatesTaking people
- Cleveland Clinic Florida - Martin North HospitalStuart, United StatesNo longer taking part
- Overlook Medical CenterSummit, United StatesTaking people
- SUNY Upstate Medical UniversitySyracuse, United StatesTaking people
- St. Joseph's HospitalTampa, United StatesNo longer taking part
- Montefiore Medical CenterThe Bronx, United StatesNo longer taking part
- Toledo Clinic Cancer CenterToledo, United StatesNo longer taking part
- Greater Baltimore Medical CenterTowson, United StatesTaking people
- Carle Cancer CenterUrbana, United StatesTaking people
- Pearlman Cancer CenterValdosta, United StatesTaking people
- MedStar Georgetown University HospitalWashington D.C., United StatesTaking people
- MedStar Washington Hospital CenterWashington D.C., United StatesTaking people
- Reading Hospital and Medical CenterWest Reading, United StatesNo longer taking part
- Clinical Research AllianceWestbury, United StatesNo longer taking part
- Weston HospitalWeston, United StatesNo longer taking part
- White Plains Hospital Physician AssociatesWhite Plains, United StatesTaking people
- Cancer Center of KansasWichita, United StatesTaking people
- Atrium Health Wake Forest BaptistWinston-Salem, United StatesTaking people
- University of Massachusetts WorcesterWorcester, United StatesNo longer taking part
- Lankenau Medical CenterWynnewood, United StatesTaking people
- Oncology and Hematology Associates of Southwest Virginia, IncWytheville, United StatesTaking people
- Cancer Care Associates of YorkYork, United StatesTaking people
- Trinity Health St Joseph Mercy Ann ArborYpsilanti, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Gilead Sciences
- Trial code
- NCT05633654EU 2024-512279-10-00
- Record updated
- 4 November 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Stage IV (metastatic) breast cancer as well as history of any prior (ipsi- or contralateral) invasive breast cancer; Prior treatment with topoisomerase 1 inhibitors or antibody-drug conjugates (ADCs) containing a topoisomerase inhibitor; Evidence of recurrent disease following preoperative therapy and surgery; Individuals with germline breast cancer gene (BRCA) mutations; Active serious infections requiring anti-microbial therapy; Note: Other protocol defined Inclusion/Exclusion criteria may apply; 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; 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%.