Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Patients With Previously Untreated Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer
ASCENT-03
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1
6 other identifiers
interventional
623
29 countries
361
Brief Summary
The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) versus treatment of physician's choice (TPC) in participants with previously untreated, locally advanced, inoperable or metastatic triple-negative breast cancer whose tumors do not express programmed cell death ligand 1 (PD-L1) or in participants previously treated with anti-programmed cell death (ligand or protein) 1 (Anti-PD-(L)1) Agents in the early setting whose tumors do express PD-L1.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2022
Longer than P75 for phase_3
361 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
May 16, 2022
CompletedFirst Posted
Study publicly available on registry
May 19, 2022
CompletedStudy Start
First participant enrolled
July 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
September 5, 2025
September 1, 2025
6 years
May 16, 2022
September 3, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
PFS is defined as the time from the date of randomization until the date of objective progressive disease (PD), or death (whichever comes first).
Randomization up to approximately 57 months
Secondary Outcomes (8)
Overall Survival (OS)
Randomization up to approximately 57 months
Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1
Randomization up to approximately 57 months
Duration of Response (DOR) as Assessed by BICR per RECIST Version 1.1
Randomization up to approximately 57 months
Time to Response (TTR) as Assessed by BICR per RECIST Version 1.1
Randomization up to approximately 57 months
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
First dose date up to approximately 57 months plus 30 days
- +3 more secondary outcomes
Study Arms (2)
Sacituzumab Govitecan-hziy (SG)
EXPERIMENTALParticipants will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle.
Treatment of Physician's Choice (TPC)
ACTIVE COMPARATORParticipants will receive TPC determined prior to randomization from 1 of the 3 allowed regimens: * Paclitaxel 90 mg/m\^2 on Days 1, 8, and 15 of a 28-day cycle * Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 of a 28-day cycle * Gemcitabine 1000 mg/m\^2 + carboplatin area under the curve (AUC) 2 on Days 1 and 8 of a 21-day cycle
Interventions
Administered intravenously
Administered intravenously
Eligibility Criteria
You may qualify if:
- Individuals, regardless of race and ethnic group, with previously untreated locally advanced, inoperable or metastatic triple-negative breast cancer (TNBC)
- Individuals whose tumors are programmed cell death ligand 1 (PD-L1) negative at screening or individuals whose tumors are PD-L1 positive at screening if they have received an anti-PD-(L)1 inhibitor in the (neo) adjuvant setting or if they cannot be treated with a checkpoint inhibitor due to a comorbidity
- Centrally confirmed TNBC and PD-L1 status on fresh or archival tissue
- Individuals must have completed treatment for Stage I-III breast cancer, if indicated, and ≥ 6 months must have elapsed (with the exception of endocrine therapy) between completion of treatment with curative intent and first documented local or distant disease recurrence
- Individuals presenting with de novo metastatic TNBC are eligible
- Measurable disease based on computed tomography (CT) or magnetic resonance imaging (MRI) in accordance with per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. as evaluated locally
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Demonstrates adequate organ function
- Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception
- Individuals with human immunodeficiency virus (HIV) must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease
You may not qualify if:
- Positive serum pregnancy test or women who are lactating
- Received systemic anticancer treatment within the previous 6 months or radiation therapy within 2 weeks prior to enrollment
- Have not recovered from adverse events (AEs) due to a previously administered agent at the time study entry
- May not be participating in a study with an investigational agent or investigational device within 4 weeks prior to randomization. Individuals participating in observational studies are eligible
- Previously received topoisomerase 1 inhibitors or antibody drug conjugates containing a topoisomerase inhibitor
- Active second malignancy
- Active serious infection requiring antibiotics
- Positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (363)
Arizona Oncology Associates, PC-Hope,1845 W Orange Grove Rd
Tucson, Arizona, 85704, United States
Arizona Oncology Associates, PC-Hope,2070 W. Rudasill Rd.
Tucson, Arizona, 85704, United States
Arizona Oncology Associates, PC-Hope
Tucson, Arizona, 85711, United States
Arizona Oncology Associates, PC-Hope,1620 West St. Mary's Road
Tucson, Arizona, 85745, United States
University of California Los Angeles - Jonsson Comprehensive Cancer Center,201 S. Buena Vista Street, Suite 200
Burbank, California, 91505, United States
University of California San Diego Moores Cancer
La Jolla, California, 92093, United States
University of California Los Angeles - Jonsson Comprehensive Cancer Center,24302 Paseo de Valencia, Suite 200
Laguna Hills, California, 91505, United States
University of California Los Angeles - Jonsson Comprehensive Cancer Center,892 Aerovista Place, Suite 240
San Luis Obispo, California, 93401, United States
University of California Los Angeles - Jonsson Comprehensive Cancer Center,2020 Santa Monica Blvd, Suite 600
Santa Monica, California, 90404, United States
University of California Los Angeles - Jonsson Comprehensive Cancer Center,2336 Santa Monica, Suites 302 and 304
Santa Monica, California, 90404, United States
University of California Los Angeles - Jonsson Comprehensive Cancer Center
Santa Monica, California, 90404, United States
Torrance Memorial Physician Network - Cancer Care
Torrance, California, 90505, United States
University of California Los Angeles - Jonsson Comprehensive Cancer Center,1250 La Venta Dr, Suite 100
Westlake Village, California, 91361, United States
Rocky Mountain Cancer Centers,1700 South Potomac Street
Aurora, Colorado, 80012, United States
Rocky Mountain Cancer Centers
Boulder, Colorado, 80303, United States
Rocky Mountain Cancer Centers,2312 N. Nevada Avenue
Colorado Springs, Colorado, 80907, United States
Rocky Mountain Cancer Centers,6031 E. Woodman Rd.
Colorado Springs, Colorado, 80923, United States
Rocky Mountain Cancer Centers,4700 E. Hale Parkway
Denver, Colorado, 80220, United States
Rocky Mountain Cancer Centers,11750 West 2nd Place
Lakewood, Colorado, 80228, United States
Rocky Mountain Cancer Centers,22 West Dry Creek Circle
Littleton, Colorado, 80120, United States
Rocky Mountain Cancer Centers,10107 Ridge Gate Parkway
Lone Tree, Colorado, 80124, United States
Rocky Mountain Cancer Centers,2030 Mountain View Ave Ste 210
Longmont, Colorado, 80124, United States
Rocky Mountain Cancer Centers,3676 Parker Blvd
Pueblo, Colorado, 81008, United States
Rocky Mountain Cancer Centers,525 W. 15th Street
Pueblo, Colorado, 81008, United States
Rocky Mountain Cancer Centers,8820 Huron Street
Thornton, Colorado, 80260, United States
AdventHealth Medical Group
Altamonte Springs, Florida, 32701, United States
Florida Cancer Specialists - North Region Research Office,750 Orienta Ave
Altamonte Springs, Florida, 32701, United States
Florida Cancer Specialists,9776 Bonita Beach Road Southeast Suite 201 A
Bonita Springs, Florida, 34135, United States
Florida Cancer Specialists,3630 Manatee Avenue West
Bradenton, Florida, 34205, United States
Florida Cancer Specialists,5985 Silver Falls Run
Bradenton, Florida, 34211, United States
Florida Cancer Specialists - North Region Research Office,403 S. Kings Ave.
Brandon, Florida, 33511, United States
Florida Cancer Specialists,1030 Commerce Creek Blvd
Cape Coral, Florida, 33909, United States
Florida Cancer Specialists - North Region Research Office,3280 McMullen Booth Road
Clearwater, Florida, 33761, United States
Florida Cancer Specialists
Fort Myers, Florida, 33901, United States
Florida Cancer Specialists,8981 Colonial Center Drive
Fort Myers, Florida, 33905, United States
Florida Cancer Specialists,8260 Gladiolus Dr
Fort Myers, Florida, 33908, United States
Florida Cancer Specialists - North Region Research Office,6420 W. Newberry Road
Gainesville, Florida, 32605, United States
Florida Cancer Specialists - North Region Research Office,100 Highland Avenue
Largo, Florida, 33770, United States
Florida Cancer Specialists - North Region Research Office,521 North Lecanto Highway
Lecanto, Florida, 34461, United States
Florida Cancer Specialists,1100 Goodlette Road
Naples, Florida, 34102, United States
Florida Cancer Specialists,681 4th Avenue North
Naples, Florida, 34102, United States
Florida Cancer Specialists - North Region Research Office,4945 SW 49th Place
Ocala, Florida, 34474, United States
Florida Cancer Specialists - North Region Research Office,2824 Enterprise Rd
Orange City, Florida, 32763, United States
AdventHealth Medical Group,2501 North Orange Ave
Orlando, Florida, 32804, United States
Florida Cancer Specialists - North Region Research Office,70 W. Gore Street
Orlando, Florida, 32806, United States
Florida Cancer Specialists,22395 Edgewater Drive
Port Charlotte, Florida, 33980, United States
Florida Cancer Specialists,600 North Cattlemen Road
Sarasota, Florida, 34232, United States
Florida Cancer Specialists,1970 Golf Street
Sarasota, Florida, 34236, United States
Florida Cancer Specialists - North Region Research Office,7154 Medical Center Drive
Spring Hill, Florida, 34608, United States
Florida Cancer Specialists - North Region Research Office,1201 Fifth Avenue North
St. Petersburg, Florida, 33705, United States
Florida Cancer Specialists - North Region Research Office
St. Petersburg, Florida, 33705, United States
Florida Cancer Specialists - North Region Research Office,3402 West Dr. Martin Luther King Jr. Boulevard
Tampa, Florida, 33607, United States
Florida Cancer Specialists - North Region Research Office,4100 Waterman Way
Tavares, Florida, 32778, United States
Florida Cancer Specialists - North Region Research Office,1400 US Highway 441 N
The Villages, Florida, 32159, United States
Florida Cancer Specialists - North Region Research Office,9320 State Road 54
Trinity, Florida, 34655, United States
Florida Cancer Specialists,901 South Tamiami Trail
Venice, Florida, 34285, United States
Florida Cancer Specialists,836 Sunset Lake Blvd
Venice, Florida, 34292, United States
Florida Cancer Specialists - North Region Research Office,460 N Orlando Ave
Winter Park, Florida, 32789, United States
Northside Hospital,125 King Avenue
Athens, Georgia, 30606, United States
Northside Hospital,5670 Peachtree Dunwoody Rd.
Atlanta, Georgia, 30342, United States
Northside Hospital
Atlanta, Georgia, 30342, United States
Northside Hospital,308 Deep South Farm Rd, Suite 200
Blairsville, Georgia, 30512, United States
Northside Hospital,228 Riverstone Dr.
Canton, Georgia, 30114, United States
Northwest Georgia Oncology Northwest Georgia Oncology Centers, PCCenters, PC,157 Clinic Avenue
Carrollton, Georgia, 30117, United States
Northwest Georgia Oncology Northwest Georgia Oncology Centers, PCCenters, PC,100 Market Place Blvd
Cartersville, Georgia, 30121, United States
Northside Hospital,1505 Northside Blvd, Suite 4600
Cumming, Georgia, 30041, United States
Northside Hospital,3855 Pleasant Hill Rd., Suite 480
Duluth, Georgia, 30096, United States
Northside Hospital,308 Coliseum Dr.
Macon, Georgia, 31217, United States
Northwest Georgia Oncology Northwest Georgia Oncology Centers, PCCenters, PC
Marietta, Georgia, 30060, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, 60611, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University,1 Kish Hospital Drive
DeKalb, Illinois, 60115, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University,10 Health Services Drive
DeKalb, Illinois, 60115, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University,300 Randall Road
Geneva, Illinois, 60134, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University,304 Randall Road
Geneva, Illinois, 60134, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University,1000 N. Westmoreland Road
Lake Forest, Illinois, 60045, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University,4405 Weaver Parkway
Warrenville, Illinois, 25731, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University,4455 Weaver Parkway
Warrenville, Illinois, 60555, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University,25 N Winfield Road
Winfield, Illinois, 60190, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Norton Cancer Institute - Saint Matthews,234 E. Gray Strret
Louisville, Kentucky, 40202, United States
Norton Cancer Institute - Saint Matthews,676 S. Floyd Street
Louisville, Kentucky, 40202, United States
Norton Cancer Institute - Saint Matthews
Louisville, Kentucky, 40207, United States
Norton Cancer Institute - Saint Matthews,4955 Norton Healthcare Blvd
Louisville, Kentucky, 40241, United States
Cancer Institute Ascension Saint Agnes
Baltimore, Maryland, 21229, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
The West Clinic, PLLC dba West Cancer Center,7668 Airways Blvd
Southaven, Mississippi, 38671, United States
New York Cancer & Blood Specialists - Port Jeffers,72 East Main St.
Babylon, New York, 11702, United States
New York Cancer & Blood Specialists - Port Jeffers,1 Delaware Dr.
New Hyde Park, New York, 11042, United States
New York Cancer & Blood Specialists - Port Jeffers,365 East Main St.
Patchogue, New York, 11772, United States
New York Cancer & Blood Specialists - Port Jeffers,1500 Rte, 112, Building 4
Port Jefferson, New York, 11776, United States
New York Cancer & Blood Specialists - Port Jeffers,49 Rte. 347, Newconset Hwy
Port Jefferson Station, New York, 11776, United States
New York Cancer & Blood Specialists - Port Jeffers
Port Jefferson Station, New York, 11776, United States
New York Cancer & Blood Specialists - Port Jeffers,750 Old County Rd. Suite 4
Riverhead, New York, 11901, United States
New York Cancer & Blood Specialists - Port Jeffers,12 East 86th St, Suite 4
The Bronx, New York, 10028, United States
New York Cancer & Blood Specialists - Port Jeffers,2330 Eastchester Road, Suite 360
The Bronx, New York, 10469, United States
Novant Health Cancer Institute - Forsyth,125 Queens Road, Suite 650
Charlotte, North Carolina, 28204, United States
Novant Health Cancer Institute - Forsyth,2131 S. 17th Street
Wilmington, North Carolina, 28401, United States
Novant Health Cancer Institute - Forsyth
Winston-Salem, North Carolina, 27103, United States
Magee-Womens Hospital of UPMC,2500 West 12th Street
Erie, Pennsylvania, 16505, United States
Magee-Womens Hospital of UPMC,201 State Street, 6 Main
Erie, Pennsylvania, 16550, United States
Magee-Womens Hospital of UPMC,4300 Londonberry Road
Harrisburg, Pennsylvania, 17109, United States
Magee-Womens Hospital of UPMC,2035 Technology Parkway
Mechanicsburg, Pennsylvania, 17050, United States
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213, United States
Magee-Womens Hospital of UPMC,5115 Centre Avenue
Pittsburgh, Pennsylvania, 15232, United States
Magee-Womens Hospital of UPMC,1703 Innovation Drive
York, Pennsylvania, 17408, United States
Tennessee Oncology, PLLC,103 Natchez Park Drive
Dickson, Tennessee, 37055, United States
Tennessee Oncology, PLLC,4488 Carothers Parkway
Franklin, Tennessee, 37067, United States
Tennessee Oncology, PLLC,225 Big Station Camp Blvd
Gallatin, Tennessee, 37066, United States
The West Clinic, PLLC dba West Cancer Center
Germantown, Tennessee, 38138, United States
Tennessee Oncology, PLLC,353 New Shackle Island Road
Hendersonville, Tennessee, 37075, United States
Tennessee Oncology, PLLC,5653 First Blvd.
Hermitage, Tennessee, 37076, United States
Tennessee Oncology, PLLC,103 Physicians Way
Lebanon, Tennessee, 37090, United States
Tennessee Oncology, PLLC,1840 Medical Center Parkway
Murfreesboro, Tennessee, 37129, United States
Tennessee Oncology, PLLC,2004 Hayes Street
Nashville, Tennessee, 37203, United States
Tennessee Oncology, PLLC,SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203, United States
Tennessee Oncology, PLLC,4220 Harding Rd
Nashville, Tennessee, 37205, United States
Tennessee Oncology, PLLC,3443 Dickerson Road
Nashville, Tennessee, 37207, United States
Tennessee Oncology, PLLC,397 Wallace Road
Nashville, Tennessee, 37211, United States
Tennessee Oncology, PLLC,120 Frank Martin Road
Shelbyville, Tennessee, 37160, United States
Tennessee Oncology, PLLC,300 Stonecrest Blvd
Smyrna, Tennessee, 37167, United States
Texas Oncology PA,901 West 38th Street
Austin, Texas, 78705, United States
Texas Oncology PA
Austin, Texas, 78731, United States
Texas Oncology PA,4101 James Casey, Suite 100
Austin, Texas, 78745, United States
Virginia Oncology Associates,744 N. Battlefield Blvd
Chesapeake, Virginia, 23320, United States
Virginia Oncology Associates,1051 Loftis Blvd Suite 100
Newport News, Virginia, 23606, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Virginia Oncology Associates,1950 Glenn Mitchell Drive
Virginia Beach, Virginia, 23456, United States
Hospital Británico de Buenos Aires
Buenos Aires, 1426, Argentina
Instituto de Oncologia Angel H.Roffo
CABA, 1417, Argentina
Fundacion CORI para la Investigacion y Prevencion del Cancer
Capital, F5300COE, Argentina
Instituto de Oncología de Rosario
Rosario, 2000, Argentina
Centro para la Atencion Integral del Paciente Oncologico Centro Médico C.A.I.P.O
San Miguel de Tucumán, 4000, Argentina
Clinica Viedma
Viedma, 8500, Argentina
Saint George Hospital - Australia
Kogarah, New South Wales, 2217, Australia
Mater Misericordiae Limited and Mater Research Limited
South Brisbane, Queensland, 4101, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Cancer Research SA (CRSA)
Adelaide, South Australia, 5000, Australia
Monash Medical Centre
Clayton, Victoria, 3168, Australia
Austin Hospital
Melbourne, Victoria, 3084, Australia
Breast Cancer Research Center - Western Australia
Nedlands, Western Australia, 6009, Australia
Medizinische Universität Innsbruck
Innsbruck, 06020, Austria
Ordensklinikum Linz GmbH Barmherzige Schwestern
Linz, 4010, Austria
Algemeen Ziekenhuis Klina
Brasschaat, 2930, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
Universitair Ziekenhuis Brussel
Brussels, Belgium
Grand Hopital de Charleroi - Notre Dame
Charleroi, 6000, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
UZ Leuven
Leuven, 3000, Belgium
Centre Hospitalier Universitaire Université Cathol
Namur, 5000, Belgium
Hospital Araújo Jorge - Associação de Combate ao Câncer em Goiás - ACCG
Goiânia, 74605-070, Brazil
ONCOSITE - Centro de Pesquisa Clinica em Oncologia
Ijuí, 98700-000, Brazil
Catarina Pesquisa Clínica
Itajaí, 88301-220, Brazil
Hospital Moinhos de Vento
Porto Alegre, 90035-00, Brazil
Hospital de Clinicas de Porto Alegre - HCPA
Porto Alegre, 90035-903, Brazil
Hospital Sao Lucas da PUCRS
Porto Alegre, 90610001, Brazil
Instituto Nacional de Câncer - INCA - HCIII
Rio de Janeiro, Brazil
Núcleo de Oncologia da Bahia
Salvador, 40170170, Brazil
CEPHO - Centro de Estudos e PesquisaS de Hematologia e Oncologia
Santo André, 09060-650, Brazil
Real e Portuguesa de Beneficéncia - Hospital Beneficéncia Portuguesa (BP) - Unidade Paulista
São Paulo, 01323-001, Brazil
Clinica de Pesquisas e Centro de Estudos em Oncolo
São Paulo, 1317000, Brazil
Fundação Pio XII - Hospital de Amor de Barretos
São Paulo, 14784400, Brazil
Hospital Amaral Carvalho
São Paulo, 17210080, Brazil
Nucleo de Pesquisa Clinica da Rede Sao Camilo
São Paulo, 4014002, Brazil
Cross Cancer Institute
Edmonton, T6G 1Z2, Canada
QEII Health Sciences Centre
Halifax, B3H 1V7, Canada
Grand River Regional Cancer Centre at Grand River Hospital
Kitchener, N2G 1G3, Canada
London Health Sciences Centre
London, N6A 5W9, Canada
Jewish General Hospital Department of Medical Oncology
Montreal, H3T 1E2, Canada
McGill University Health Centre
Montreal, H4A 3J1, Canada
Ottawa Hospital - General Campus
Ottawa, K1H 8L6, Canada
Sunnybrook Research Institute
Toronto, M4N 3M5, Canada
Mount Sinai Hospital
Toronto, M5G 1X5, Canada
Oncovida - Santiago
Providencia, 7510035, Chile
Clínica Alemana
Santiago, 7630000, Chile
Clínica IRAM
Santiago, Chile
Centro de Oncología de Precisión
Santiago Region, 8330032, Chile
James Lind Centro de Investigacion del Cancer
Temuco, Chile
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, 100021, China
Peking University People's Hospital
Beijing, 100044, China
Beijing Cancer Hospital
Beijing, 100142, China
The First Medical Center of Chinese PLA General Hospital
Beijing, 100853, China
The Second Xiangya Hospital of Central South University
Changsha, 410011, China
Sichuan Cancer Hospital
Chengdu, 610041, China
West China Hospital, Sichuan University
Chengdu, 610041, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, 400016, China
Chongqing University Cancer Hospital
Chongqing, 404100, China
Deyang People's Hospital
Deyang, 618000, China
Sun Yat-Sen University Cancer Center
Guangzhou, 510000, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, 31006, China
Harbin Medical University Cancer Hospital
Harbin, 150081, China
Anhui Provincial Cancer Hospital
Hefei, 230031, China
The Second Hospital of Anhui Medical University
Hefei, 230601, China
The Second Hospital of Jilin University
Jilin Sheng, 130041, China
The Second Hospital of Shandong University
Jinan, 250033, China
Shandong Cancer Hospital
Jinan, 250117, China
Nanchang People's hospital
Nanchang, 330200, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, 530021, China
Tianjin Medical University Cancer Institute& Hospital
Tianjin, 453000, China
Weihai Municipal Hospital
Weihai, 264299, China
Hubei Cancer Hospital
Wuhan, 430000, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, 430022, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, 430030, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, 710061, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Zhejiang, 310009, China
The First Affiliated Hospital of Wenzhou Medical University
Zhejiang, 325000, China
Masarykuv onkologicky ustav, klinika komplexni onkologickie pece
Brno, 65653, Czechia
Fakultni nemocnice Hradec Kravlove, Klinika onkologie a radioterapie
Hradec Králové, 500 05, Czechia
Fakultní Thomayerova nemocnice
Hradec Králové, 50005, Czechia
Fakultni nemocnice Olomouc, Onkologicka klinika
Olomouc, 77520, Czechia
Fakultni nemocnice Karlovske Vinohrady, Radioterapeuticka a onkologicka klinika
Prague, 100 34, Czechia
Vseobecna Fakultni Nemocnice v Praze
Prague, 12808, Czechia
Sainte Catherine Institut du Cancer Avignon Provence
Avignon, 84918, France
Centre Hospitalier Régional et Universitaire de Be
Besançon, 25030, France
Hôpital Morvan, Institut de cancérologie
Brest, 29200, France
Centre francois Baclesse
Caen, 14000, France
Centre Jean Perrin
Clermont-Ferrand, 63011, France
Centre de Cancérologie du Grand Montpellier
Montpellier, 34070, France
Hôpital Privé du Confluent
Nantes, 44202, France
Hospices Civils de Lyon Hôpital Lyon Sud
Pierre-Bénite, 69310, France
Centre Armoricain de Radiothérapie, dImagerie Méd
Plérin, 22190, France
Centre Eugène Marquis
Rennes, 35042, France
Institut Claudius Regaud - IUCT-O
Toulouse, France
Institut Gustave Roussy
Villejuif, 94800, France
Helios Klinikum Berlin-Buch
Berlin, 13125, Germany
Gynakologisches Zentrum Bonn, Schwerpunkt Gyn. Onkologie,
Bonn, 53111, Germany
Klinik Frauenheilkunde, Uniklinik ClO, Studienzentrale
Cologne, 50937, Germany
Kliniken Essen-Mitte - Evangelische Huyssens-Stift Breast Unit
Essen, 45136, Germany
Universitatsklinikum Hamburg-Eppendorf
Hamburg, 20246, Germany
Nationales Centrum für Tumorerkrankungen - Heidelb
Heidelberg, 69120, Germany
Universitätsklinikum Schleswig-Holstein Institut fur Klinische Chermie
Lübeck, 23538, Germany
Universitatsklinikum Mannheim GmBH, Frauenklinik
Mannheim, 68167, Germany
Universitätsklinikum Tübingen
Tübingen, 72076, Germany
Queen Mary Hospital
Hong Kong, Hong Kong
Tuen Mun Hospital
Hong Kong, Hong Kong
Queen Mary Hospital
Pok Fu Lam, 0, Hong Kong
Uzsoki Utcai Kornaz, Onkoradiologiai Osztaly
Budapest, 1145, Hungary
Debreceni Egyetem Klinikai Központ
Debrecen, 4032, Hungary
Petz Aladar Egyetemi Oktaté Kérhaz - Osztaly
Győr, 9024, Hungary
Rambam Health Care Campus
Haifa, 3109601, Israel
Hadassah - Hebrew University Medical Center
Jerusalem, Israel
Meir Medical Center
Kfar Saba, 4428164, Israel
Rabin Medical Center
Petah Tikva, 4941492, Israel
Kaplan Medical Center
Rehovot, 7661041, Israel
Sheba Medical Center Hospital - Tel Hashomer
Tel Aviv, 52621, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
IRCCS Istituto Tumori "G.Paolo II"
Bari, 70124, Italy
SSD Oncologia Medica Addarii-Zamagni, IRCSS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola
Bologna, Italy
UO Oncologia, ASST degli Spedali Civili di Brescia
Brescia, 25123, Italy
IRCSS Ospedale Policlinico San Martino
Genova GE, 16132, Italy
S.C. Oncologia medica, ASST di Lecco
Lecco, 23900, Italy
Presidio Ospedaliero di Lucca
Lucca, 55100, Italy
Ospedale Generale Provinciale - Macerata
Macerata, 62100, Italy
Istituto Europeo di Oncologia
Milan, 20141, Italy
Fondazione IRCCS - Istituto Nazionale dei Tumori
Milan, 20133, Italy
Azienda Socio Sanitaria Territoriale
Monza, 20090, Italy
Oncologia Medica Senologica Sperimentale - Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Napoli, 80131, Italy
Azienda Ospedaliero-Universitaria Maggiore della C
Novara, 28100, Italy
Istituto Oncologico Veneto - IRCCS
Padua, 35128, Italy
AOU Policlinico Umberto I
Roma, 00161, Italy
Fondazione Policlinico Universitario Agostino Geme
Rome, 00168, Italy
Aichi Cancer Center Hospital
Aichi, 464-8681, Japan
Juntendo University Hospital
Bunkyō City, 113-8431, Japan
Chiba Cancer Center
Chūōku, 260-8717, Japan
Shikoku Cancer Center
Ehime, 791-0280, Japan
Hakuaikai Sagara Hospital
Kagoshima, 892-0833, Japan
National Cancer Center Hospital East
Kashiwa, 277-8577, Japan
Cancer Institute Hospital of JFCR
Kōtoku, 135-8550, Japan
Kumamoto University Hospital
Kumamoto, 860-8556, Japan
Kure Medical Center And Chugoku Cancer Center
Kure, 737-0023, Japan
National Hospital Organization Kyushu Cancer Center
Minamiku, 811-1395, Japan
Nagoya University Hospital
Nagoya, 466-8560, Japan
Hiroshima City Hiroshima Citizens Hospital
Nakaku, 730-8518, Japan
Okayama University Hospital
Okayama, 700-8558, Japan
Kyoto University Hospital
Sakyo-ku, 606-8507, Japan
Hokkaido Cancer Center
Sapporo, 003-0804, Japan
Shizuoka Cancer Center
Shizuoka, 411-8777, Japan
Shizuoka General Hospital
Shizuoka, 420-8527, Japan
Osaka University Hospital
Suita, 565-0871, Japan
Showa University Hospital
Tokyo, 142-8555, Japan
Kanagawa Cancer Center
Yokohama, 241-8515, Japan
Hospital Pulau Pinang
George Town, 10450, Malaysia
Hospital Sultan Ismail
Johor Bahru, 81100, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, 47500, Malaysia
Pantai Hospital Kuala Lumpur
Kuala Lumpur, 59100, Malaysia
University Malaya Medical Centre (UMMC)
Kuala Lumpur, 59100, Malaysia
Institut Kanser Negara
Putrajaya, 62250, Malaysia
Sarawak General Hospital
Sarawak, 93586, Malaysia
Icaro Investigaciones en Medicina
Chihuahua City, 31000, Mexico
Sinacor - Centro para el Desarrollo de la Medicina
Culiacán, 80230, Mexico
Panamerican Clinical Research Mexico - Guadalajara
Guadalajara, 44670, Mexico
Cryptex Investigación Clínica
Mexico City, 06100, Mexico
Medical Care and Research S.A. de C.V.
Mérida, 97070, Mexico
Fucam A.C.
México, 4980, Mexico
Avix Investigacion Clinica S.C.
Monterrey, 64710, Mexico
Oncológico Potosino
San Luis Potosí City, 78209, Mexico
FAICIC Clínical Research
Veracruz, 91900, Mexico
iBiomed - Investigacion Biomedica para el Desarrol
Zapopan, 45070, Mexico
Amphia Ziekenhuis - Breda Langendijk
Breda, 4818 CK, Netherlands
Universitair Medisch Centrum Groningen
Groningen, 9700 RB, Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, 8934 AD, Netherlands
Maastricht Universitair Medisch Centrum
Maastricht, 6229HX, Netherlands
Erasmus Medisch Centrum
Rotterdam, Netherlands
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
Gdansk, 80-952, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej
Gliwice, 44-102, Poland
SP ZOZ Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego
Opole, 45-061, Poland
Mazowiecki Szpital Wojewódzki im. w. Jana Pawa II
Siedlce, 08-110, Poland
Narodowy Instytut Onkologii im.Marii Marii Sklodowskiej
Warsaw, 02-781, Poland
Spitalul Clinic Filantropia
Bucharest, 11171, Romania
SC Medisprof SRL
Cluj-Napoca, 400058, Romania
Institutal Oncologic, Prof. Dr Ion Chiricuta
Cluj-Napoca, 400150, Romania
Centrul De Oncologie Sf Nectarie
Craiova, 200642, Romania
Onkologicky Ustav Sv. Alzbety
Bratislava, 81250, Slovakia
Národný onkologický ústav
Bratislava, 83310, Slovakia
Nemocnica Partizánske
Partizánske, 95801, Slovakia
Hopelands Cancer Centre
Hilton, 3245, South Africa
Wits Clinical Research
Johannesburg, 2192, South Africa
The Medical Oncology Centre of Rosebank
Johannesburg, 2196, South Africa
National Cancer Center
Goyang-si Gyeonggi-do, 10408, South Korea
Seoul National University Bundang Hospital
Seongnam-si, 13620, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591, South Korea
Korea University Anam Hospital
Seoul, 2841, South Korea
Seoul National University Hospital
Seoul, 3080, South Korea
Hospital Teresa Herrera - Materno Infantil
A Coruña, 15006, Spain
Hospital Universitari Dexeus
Barcelona, 08028, Spain
Hospital Universitari Vall d'Hebrón
Barcelona, 8035, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 8041, Spain
Hospital Universitario de Basurto
Bilbao, 48013, Spain
Hospital Universitari Arnau de Vilanova
Lleida, 25198, Spain
Hospital General Universitario Gregorio Maranon
Madrid, 28007, Spain
MD Anderson Cancer Center Madrid
Madrid, 28033, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040, Spain
Hospital General Universitario Morales Meseguer
Murcia, 30008, Spain
Hospital Unviersitario Virgen del Rocio
Seville, 41013, Spain
Hospital Universitario Virgen Macarena
Seville, 41071, Spain
Hospital Clínico Universitario de Valencia
Valencia, 46010, Spain
Kantonsspital St.Gallen
Sankt Gallen, 9007, Switzerland
Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Hualien City, 970, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
Chi Mei Hospital, Lioying
Tainan, 73657, Taiwan
National Taiwan University Hospital
Taipei, 10048, Taiwan
MacKay Medical Foundation The Presbyterian Church in Taiwan MacKay Memorial Hospital
Taipei, 104217, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan, 33305, Taiwan
Baskent Uni. Dr Turgut Noyan Uyg. ve Aras. Merkezi
Adana, 1120, Turkey (Türkiye)
Memorial Ankara Hastanesi
Ankara, 06520, Turkey (Türkiye)
Ankara Il Saglik Mudurlugu SBU Gulhane Egitim Ve A
Ankara, 6010, Turkey (Türkiye)
Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
Ankara, 6200, Turkey (Türkiye)
Hacettepe Üniversitesi Hastanesi
Ankara, Turkey (Türkiye)
Trakya Universitesi Tip Fakultesi Hastanesi
Edirne, 22030, Turkey (Türkiye)
Istanbul Il Saglik Mudurlugu Goztepe Prof. Dr. Sul
Istanbul, 34000, Turkey (Türkiye)
Medipol Mega Universite Hastanesi
Istanbul, 34214, Turkey (Türkiye)
Ege Universitesi Hastanesi
Izmir, 35100, Turkey (Türkiye)
Medicana International Izmir Hastanesi
Izmir, 35575, Turkey (Türkiye)
Acibadem Maslak Hastanesi
Sarıyer, Turkey (Türkiye)
Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF, United Kingdom
Barts Health NHS Trust
London, EC1M 6BQ, United Kingdom
University College London Hospitals NHS Foundation
London, WC1E 6BT, United Kingdom
Related Publications (1)
Cortes J, Punie K, Barrios C, Hurvitz SA, Schneeweiss A, Sohn J, Tokunaga E, Brufsky A, Park YH, Xu B, Hegg R, Oliveira M, Fabi A, Vaksman N, Valdez T, Zhang X, Lai C, Tolaney SM; ASCENT-03 Clinical Trial Investigators. Sacituzumab Govitecan in Untreated, Advanced Triple-Negative Breast Cancer. N Engl J Med. 2025 Nov 13;393(19):1912-1925. doi: 10.1056/NEJMoa2511734. Epub 2025 Oct 19.
PMID: 41124233DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
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
May 16, 2022
First Posted
May 19, 2022
Study Start
July 20, 2022
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
July 1, 2028
Last Updated
September 5, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share