AzTrials
AzTrials

Triple Negative Breast CancerPhase 3ASCENT-03NCT05382299

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

A Phase 3 study testing Sacituzumab Govitecan-hziy, Paclitaxel and nab-Paclitaxel in people with Triple Negative Breast Cancer and PD-L1 Negative, run by Gilead Sciences at 363 sites in 30 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Triple Negative Breast Cancer, PD-L1 Negative
What is being tested?
Sacituzumab Govitecan-hziy, Paclitaxel and nab-Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
623 participants
Where
363 sitesin 30 countries
Study dates
20 Jul 2022to Jul 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

363 sites in 30 countries.

363 sites in 30 countries

United States130 sites

  • AdventHealth Medical Group

    Altamonte Springs, Florida, 32701

  • Florida Cancer Specialists - North Region Research Office,750 Orienta Ave

    Altamonte Springs, Florida, 32701

  • Northside Hospital,125 King Avenue

    Athens, Georgia, 30606

  • Northside Hospital,5670 Peachtree Dunwoody Rd.

    Atlanta, Georgia, 30342

  • Northside Hospital

    Atlanta, Georgia, 30342

  • Rocky Mountain Cancer Centers,1700 South Potomac Street

    Aurora, Colorado, 80012

  • Texas Oncology PA,901 West 38th Street

    Austin, Texas, 78705

  • Texas Oncology PA

    Austin, Texas, 78731

  • Texas Oncology PA,4101 James Casey, Suite 100

    Austin, Texas, 78745

  • New York Cancer & Blood Specialists - Port Jeffers,72 East Main St.

    Babylon, New York, 11702

  • Cancer Institute Ascension Saint Agnes

    Baltimore, Maryland, 21229

  • Northside Hospital,308 Deep South Farm Rd, Suite 200

    Blairsville, Georgia, 30512

  • Florida Cancer Specialists,9776 Bonita Beach Road Southeast Suite 201 A

    Bonita Springs, Florida, 34135

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Rocky Mountain Cancer Centers

    Boulder, Colorado, 80303

  • Florida Cancer Specialists,3630 Manatee Avenue West

    Bradenton, Florida, 34205

  • Florida Cancer Specialists,5985 Silver Falls Run

    Bradenton, Florida, 34211

  • Florida Cancer Specialists - North Region Research Office,403 S. Kings Ave.

    Brandon, Florida, 33511

  • University of California Los Angeles - Jonsson Comprehensive Cancer Center,201 S. Buena Vista Street, Suite 200

    Burbank, California, 91505

  • Northside Hospital,228 Riverstone Dr.

    Canton, Georgia, 30114

  • Florida Cancer Specialists,1030 Commerce Creek Blvd

    Cape Coral, Florida, 33909

  • Northwest Georgia Oncology Northwest Georgia Oncology Centers, PCCenters, PC,157 Clinic Avenue

    Carrollton, Georgia, 30117

  • Northwest Georgia Oncology Northwest Georgia Oncology Centers, PCCenters, PC,100 Market Place Blvd

    Cartersville, Georgia, 30121

  • Novant Health Cancer Institute - Forsyth,125 Queens Road, Suite 650

    Charlotte, North Carolina, 28204

  • Virginia Oncology Associates,744 N. Battlefield Blvd

    Chesapeake, Virginia, 23320

  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University

    Chicago, Illinois, 60611

  • Florida Cancer Specialists - North Region Research Office,3280 McMullen Booth Road

    Clearwater, Florida, 33761

  • Rocky Mountain Cancer Centers,2312 N. Nevada Avenue

    Colorado Springs, Colorado, 80907

  • Rocky Mountain Cancer Centers,6031 E. Woodman Rd.

    Colorado Springs, Colorado, 80923

  • Northside Hospital,1505 Northside Blvd, Suite 4600

    Cumming, Georgia, 30041

  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University,1 Kish Hospital Drive

    DeKalb, Illinois, 60115

  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University,10 Health Services Drive

    DeKalb, Illinois, 60115

  • Rocky Mountain Cancer Centers,4700 E. Hale Parkway

    Denver, Colorado, 80220

  • Tennessee Oncology, PLLC,103 Natchez Park Drive

    Dickson, Tennessee, 37055

  • Northside Hospital,3855 Pleasant Hill Rd., Suite 480

    Duluth, Georgia, 30096

  • Magee-Womens Hospital of UPMC,2500 West 12th Street

    Erie, Pennsylvania, 16505

  • Magee-Womens Hospital of UPMC,201 State Street, 6 Main

    Erie, Pennsylvania, 16550

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901

  • Florida Cancer Specialists,8981 Colonial Center Drive

    Fort Myers, Florida, 33905

  • Florida Cancer Specialists,8260 Gladiolus Dr

    Fort Myers, Florida, 33908

  • Tennessee Oncology, PLLC,4488 Carothers Parkway

    Franklin, Tennessee, 37067

  • Florida Cancer Specialists - North Region Research Office,6420 W. Newberry Road

    Gainesville, Florida, 32605

  • Tennessee Oncology, PLLC,225 Big Station Camp Blvd

    Gallatin, Tennessee, 37066

  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University,300 Randall Road

    Geneva, Illinois, 60134

  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University,304 Randall Road

    Geneva, Illinois, 60134

  • The West Clinic, PLLC dba West Cancer Center

    Germantown, Tennessee, 38138

  • Magee-Womens Hospital of UPMC,4300 Londonberry Road

    Harrisburg, Pennsylvania, 17109

  • Tennessee Oncology, PLLC,353 New Shackle Island Road

    Hendersonville, Tennessee, 37075

  • Tennessee Oncology, PLLC,5653 First Blvd.

    Hermitage, Tennessee, 37076

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • University of California San Diego Moores Cancer

    La Jolla, California, 92093

  • University of California Los Angeles - Jonsson Comprehensive Cancer Center,24302 Paseo de Valencia, Suite 200

    Laguna Hills, California, 91505

  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University,1000 N. Westmoreland Road

    Lake Forest, Illinois, 60045

  • Rocky Mountain Cancer Centers,11750 West 2nd Place

    Lakewood, Colorado, 80228

  • Florida Cancer Specialists - North Region Research Office,100 Highland Avenue

    Largo, Florida, 33770

  • Tennessee Oncology, PLLC,103 Physicians Way

    Lebanon, Tennessee, 37090

  • Florida Cancer Specialists - North Region Research Office,521 North Lecanto Highway

    Lecanto, Florida, 34461

  • Rocky Mountain Cancer Centers,22 West Dry Creek Circle

    Littleton, Colorado, 80120

  • Rocky Mountain Cancer Centers,10107 Ridge Gate Parkway

    Lone Tree, Colorado, 80124

  • Rocky Mountain Cancer Centers,2030 Mountain View Ave Ste 210

    Longmont, Colorado, 80124

  • Norton Cancer Institute - Saint Matthews,234 E. Gray Strret

    Louisville, Kentucky, 40202

  • Norton Cancer Institute - Saint Matthews,676 S. Floyd Street

    Louisville, Kentucky, 40202

  • Norton Cancer Institute - Saint Matthews

    Louisville, Kentucky, 40207

  • Norton Cancer Institute - Saint Matthews,4955 Norton Healthcare Blvd

    Louisville, Kentucky, 40241

  • Northside Hospital,308 Coliseum Dr.

    Macon, Georgia, 31217

  • Northwest Georgia Oncology Northwest Georgia Oncology Centers, PCCenters, PC

    Marietta, Georgia, 30060

  • Magee-Womens Hospital of UPMC,2035 Technology Parkway

    Mechanicsburg, Pennsylvania, 17050

  • Tennessee Oncology, PLLC,1840 Medical Center Parkway

    Murfreesboro, Tennessee, 37129

  • Florida Cancer Specialists,1100 Goodlette Road

    Naples, Florida, 34102

  • Florida Cancer Specialists,681 4th Avenue North

    Naples, Florida, 34102

  • Tennessee Oncology, PLLC,2004 Hayes Street

    Nashville, Tennessee, 37203

  • Tennessee Oncology, PLLC,SCRI Oncology Partners

    Nashville, Tennessee, 37203

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203

  • Tennessee Oncology, PLLC,4220 Harding Rd

    Nashville, Tennessee, 37205

  • Tennessee Oncology, PLLC,3443 Dickerson Road

    Nashville, Tennessee, 37207

  • Tennessee Oncology, PLLC,397 Wallace Road

    Nashville, Tennessee, 37211

  • New York Cancer & Blood Specialists - Port Jeffers,1 Delaware Dr.

    New Hyde Park, New York, 11042

  • Virginia Oncology Associates,1051 Loftis Blvd Suite 100

    Newport News, Virginia, 23606

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Florida Cancer Specialists - North Region Research Office,4945 SW 49th Place

    Ocala, Florida, 34474

  • Florida Cancer Specialists - North Region Research Office,2824 Enterprise Rd

    Orange City, Florida, 32763

  • AdventHealth Medical Group,2501 North Orange Ave

    Orlando, Florida, 32804

  • Florida Cancer Specialists - North Region Research Office,70 W. Gore Street

    Orlando, Florida, 32806

  • New York Cancer & Blood Specialists - Port Jeffers,365 East Main St.

    Patchogue, New York, 11772

  • University of Pennsylvania Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Magee-Womens Hospital of UPMC

    Pittsburgh, Pennsylvania, 15213

  • Magee-Womens Hospital of UPMC,5115 Centre Avenue

    Pittsburgh, Pennsylvania, 15232

  • Florida Cancer Specialists,22395 Edgewater Drive

    Port Charlotte, Florida, 33980

  • New York Cancer & Blood Specialists - Port Jeffers,1500 Rte, 112, Building 4

    Port Jefferson, New York, 11776

  • New York Cancer & Blood Specialists - Port Jeffers,49 Rte. 347, Newconset Hwy

    Port Jefferson Station, New York, 11776

  • New York Cancer & Blood Specialists - Port Jeffers

    Port Jefferson Station, New York, 11776

  • Rocky Mountain Cancer Centers,3676 Parker Blvd

    Pueblo, Colorado, 81008

  • Rocky Mountain Cancer Centers,525 W. 15th Street

    Pueblo, Colorado, 81008

  • New York Cancer & Blood Specialists - Port Jeffers,750 Old County Rd. Suite 4

    Riverhead, New York, 11901

  • University of California Los Angeles - Jonsson Comprehensive Cancer Center,892 Aerovista Place, Suite 240

    San Luis Obispo, California, 93401

  • University of California Los Angeles - Jonsson Comprehensive Cancer Center,2020 Santa Monica Blvd, Suite 600

    Santa Monica, California, 90404

  • University of California Los Angeles - Jonsson Comprehensive Cancer Center,2336 Santa Monica, Suites 302 and 304

    Santa Monica, California, 90404

  • University of California Los Angeles - Jonsson Comprehensive Cancer Center

    Santa Monica, California, 90404

  • Florida Cancer Specialists,600 North Cattlemen Road

    Sarasota, Florida, 34232

  • Florida Cancer Specialists,1970 Golf Street

    Sarasota, Florida, 34236

  • Tennessee Oncology, PLLC,120 Frank Martin Road

    Shelbyville, Tennessee, 37160

  • Tennessee Oncology, PLLC,300 Stonecrest Blvd

    Smyrna, Tennessee, 37167

  • The West Clinic, PLLC dba West Cancer Center,7668 Airways Blvd

    Southaven, Mississippi, 38671

  • Florida Cancer Specialists - North Region Research Office,7154 Medical Center Drive

    Spring Hill, Florida, 34608

  • Florida Cancer Specialists - North Region Research Office,1201 Fifth Avenue North

    St. Petersburg, Florida, 33705

  • Florida Cancer Specialists - North Region Research Office

    St. Petersburg, Florida, 33705

  • Florida Cancer Specialists - North Region Research Office,3402 West Dr. Martin Luther King Jr. Boulevard

    Tampa, Florida, 33607

  • Florida Cancer Specialists - North Region Research Office,4100 Waterman Way

    Tavares, Florida, 32778

  • New York Cancer & Blood Specialists - Port Jeffers,12 East 86th St, Suite 4

    The Bronx, New York, 10028

  • New York Cancer & Blood Specialists - Port Jeffers,2330 Eastchester Road, Suite 360

    The Bronx, New York, 10469

  • Florida Cancer Specialists - North Region Research Office,1400 US Highway 441 N

    The Villages, Florida, 32159

  • Rocky Mountain Cancer Centers,8820 Huron Street

    Thornton, Colorado, 80260

  • Torrance Memorial Physician Network - Cancer Care

    Torrance, California, 90505

  • Florida Cancer Specialists - North Region Research Office,9320 State Road 54

    Trinity, Florida, 34655

  • Arizona Oncology Associates, PC-Hope,1845 W Orange Grove Rd

    Tucson, Arizona, 85704

  • Arizona Oncology Associates, PC-Hope,2070 W. Rudasill Rd.

    Tucson, Arizona, 85704

  • Arizona Oncology Associates, PC-Hope

    Tucson, Arizona, 85711

  • Arizona Oncology Associates, PC-Hope,1620 West St. Mary's Road

    Tucson, Arizona, 85745

  • Florida Cancer Specialists,901 South Tamiami Trail

    Venice, Florida, 34285

  • Florida Cancer Specialists,836 Sunset Lake Blvd

    Venice, Florida, 34292

  • Virginia Oncology Associates,1950 Glenn Mitchell Drive

    Virginia Beach, Virginia, 23456

  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University,4405 Weaver Parkway

    Warrenville, Illinois, 25731

  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University,4455 Weaver Parkway

    Warrenville, Illinois, 60555

  • University of California Los Angeles - Jonsson Comprehensive Cancer Center,1250 La Venta Dr, Suite 100

    Westlake Village, California, 91361

  • Novant Health Cancer Institute - Forsyth,2131 S. 17th Street

    Wilmington, North Carolina, 28401

  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University,25 N Winfield Road

    Winfield, Illinois, 60190

  • Novant Health Cancer Institute - Forsyth

    Winston-Salem, North Carolina, 27103

  • Florida Cancer Specialists - North Region Research Office,460 N Orlando Ave

    Winter Park, Florida, 32789

  • Magee-Womens Hospital of UPMC,1703 Innovation Drive

    York, Pennsylvania, 17408

Other trials in United States

China28 sites

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, 100021

  • Peking University People's Hospital

    Beijing, 100044

  • Beijing Cancer Hospital

    Beijing, 100142

  • The First Medical Center of Chinese PLA General Hospital

    Beijing, 100853

  • The Second Xiangya Hospital of Central South University

    Changsha, 410011

  • Sichuan Cancer Hospital

    Chengdu, 610041

  • West China Hospital, Sichuan University

    Chengdu, 610041

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, 400016

  • Chongqing University Cancer Hospital

    Chongqing, 404100

  • Deyang People's Hospital

    Deyang, 618000

  • Sun Yat-Sen University Cancer Center

    Guangzhou, 510000

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, 31006

  • Harbin Medical University Cancer Hospital

    Harbin, 150081

  • Anhui Provincial Cancer Hospital

    Hefei, 230031

  • The Second Hospital of Anhui Medical University

    Hefei, 230601

  • The Second Hospital of Jilin University

    Jilin Sheng, 130041

  • The Second Hospital of Shandong University

    Jinan, 250033

  • Shandong Cancer Hospital

    Jinan, 250117

  • Nanchang People's hospital

    Nanchang, 330200

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, 530021

  • Tianjin Medical University Cancer Institute& Hospital

    Tianjin, 453000

  • Weihai Municipal Hospital

    Weihai, 264299

  • Hubei Cancer Hospital

    Wuhan, 430000

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, 430022

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, 430030

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, 710061

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Zhejiang, 310009

  • The First Affiliated Hospital of Wenzhou Medical University

    Zhejiang, 325000

Other trials in China

Japan20 sites

  • Aichi Cancer Center Hospital

    Aichi, 464-8681

  • Juntendo University Hospital

    Bunkyō City, 113-8431

  • Chiba Cancer Center

    Chūōku, 260-8717

  • Shikoku Cancer Center

    Ehime, 791-0280

  • Hakuaikai Sagara Hospital

    Kagoshima, 892-0833

  • National Cancer Center Hospital East

    Kashiwa, 277-8577

  • Cancer Institute Hospital of JFCR

    Kōtoku, 135-8550

  • Kumamoto University Hospital

    Kumamoto, 860-8556

  • Kure Medical Center And Chugoku Cancer Center

    Kure, 737-0023

  • National Hospital Organization Kyushu Cancer Center

    Minamiku, 811-1395

  • Nagoya University Hospital

    Nagoya, 466-8560

  • Hiroshima City Hiroshima Citizens Hospital

    Nakaku, 730-8518

  • Okayama University Hospital

    Okayama, 700-8558

  • Kyoto University Hospital

    Sakyo-ku, 606-8507

  • Hokkaido Cancer Center

    Sapporo, 003-0804

  • Shizuoka Cancer Center

    Shizuoka, 411-8777

  • Shizuoka General Hospital

    Shizuoka, 420-8527

  • Osaka University Hospital

    Suita, 565-0871

  • Showa University Hospital

    Tokyo, 142-8555

  • Kanagawa Cancer Center

    Yokohama, 241-8515

Other trials in Japan

Italy15 sites

  • IRCCS Istituto Tumori "G.Paolo II"

    Bari, 70124

  • SSD Oncologia Medica Addarii-Zamagni, IRCSS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola

    Bologna

  • UO Oncologia, ASST degli Spedali Civili di Brescia

    Brescia, 25123

  • IRCSS Ospedale Policlinico San Martino

    Genova GE, 16132

  • S.C. Oncologia medica, ASST di Lecco

    Lecco, 23900

  • Presidio Ospedaliero di Lucca

    Lucca, 55100

  • Istituto Europeo di Oncologia

    Milan, 20141

  • Fondazione IRCCS - Istituto Nazionale dei Tumori

    Milan, 20133

  • Azienda Socio Sanitaria Territoriale

    Monza, 20090

  • Oncologia Medica Senologica Sperimentale - Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

    Naples, 80131

  • Azienda Ospedaliero-Universitaria Maggiore della C

    Novara, 28100

  • Istituto Oncologico Veneto - IRCCS

    Padova, 35128

  • Ospedale Generale Provinciale - Macerata

    Province of Macerata, 62100

  • AOU Policlinico Umberto I

    Roma, 00161

  • Fondazione Policlinico Universitario Agostino Geme

    Rome, 00168

Other trials in Italy

Brazil14 sites

  • Hospital Araújo Jorge - Associação de Combate ao Câncer em Goiás - ACCG

    Goiânia, 74605-070

  • ONCOSITE - Centro de Pesquisa Clinica em Oncologia

    Ijuí, 98700-000

  • Catarina Pesquisa Clínica

    Itajaí, 88301-220

  • Hospital Moinhos de Vento

    Porto Alegre, 90035-00

  • Hospital de Clinicas de Porto Alegre - HCPA

    Porto Alegre, 90035-903

  • Hospital Sao Lucas da PUCRS

    Porto Alegre, 90610001

  • Instituto Nacional de Câncer - INCA - HCIII

    Rio de Janeiro

  • Núcleo de Oncologia da Bahia

    Salvador, 40170170

  • CEPHO - Centro de Estudos e PesquisaS de Hematologia e Oncologia

    Santo André, 09060-650

  • Real e Portuguesa de Beneficéncia - Hospital Beneficéncia Portuguesa (BP) - Unidade Paulista

    São Paulo, 01323-001

  • Clinica de Pesquisas e Centro de Estudos em Oncolo

    São Paulo, 1317000

  • Fundação Pio XII - Hospital de Amor de Barretos

    São Paulo, 14784400

  • Hospital Amaral Carvalho

    São Paulo, 17210080

  • Nucleo de Pesquisa Clinica da Rede Sao Camilo

    São Paulo, 4014002

Other trials in Brazil

Spain13 sites

  • Hospital Teresa Herrera - Materno Infantil

    A Coruña, 15006

  • Hospital Universitari Dexeus

    Barcelona, 08028

  • Hospital Universitari Vall d'Hebrón

    Barcelona, 8035

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 8041

  • Hospital Universitario de Basurto

    Bilbao, 48013

  • Hospital Universitari Arnau de Vilanova

    Lleida, 25198

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

  • MD Anderson Cancer Center Madrid

    Madrid, 28033

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040

  • Hospital General Universitario Morales Meseguer

    Murcia, 30008

  • Hospital Unviersitario Virgen del Rocio

    Seville, 41013

  • Hospital Universitario Virgen Macarena

    Seville, 41071

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

France12 sites

  • Sainte Catherine Institut du Cancer Avignon Provence

    Avignon, 84918

  • Centre Hospitalier Régional et Universitaire de Be

    Besançon, 25030

  • Hôpital Morvan, Institut de cancérologie

    Brest, 29200

  • Centre francois Baclesse

    Caen, 14000

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Centre de Cancérologie du Grand Montpellier

    Montpellier, 34070

  • Hôpital Privé du Confluent

    Nantes, 44202

  • Hospices Civils de Lyon Hôpital Lyon Sud

    Pierre-Bénite, 69310

  • Centre Armoricain de Radiothérapie, dImagerie Méd

    Plérin, 22190

  • Centre Eugène Marquis

    Rennes, 35042

  • Institut Claudius Regaud - IUCT-O

    Toulouse

  • Institut Gustave Roussy

    Villejuif, 94800

Other trials in France

Turkey (Türkiye)11 sites

  • Baskent Uni. Dr Turgut Noyan Uyg. ve Aras. Merkezi

    Adana, 1120

  • Memorial Ankara Hastanesi

    Ankara, 06520

  • Ankara Il Saglik Mudurlugu SBU Gulhane Egitim Ve A

    Ankara, 6010

  • Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

    Ankara, 6200

  • Hacettepe Üniversitesi Hastanesi

    Ankara

  • Trakya Universitesi Tip Fakultesi Hastanesi

    Edirne, 22030

  • Istanbul Il Saglik Mudurlugu Goztepe Prof. Dr. Sul

    Istanbul, 34000

  • Medipol Mega Universite Hastanesi

    Istanbul, 34214

  • Ege Universitesi Hastanesi

    Izmir, 35100

  • Medicana International Izmir Hastanesi

    Izmir, 35575

  • Acibadem Maslak Hastanesi

    Sariyer

Other trials in Turkey (Türkiye)

Mexico10 sites

  • Icaro Investigaciones en Medicina

    Chihuahua City, 31000

  • Sinacor - Centro para el Desarrollo de la Medicina

    Culiacán, 80230

  • Panamerican Clinical Research Mexico - Guadalajara

    Guadalajara, 44670

  • Medical Care and Research S.A. de C.V.

    Mérida, 97070

  • Fucam A.C.

    México, 4980

  • Cryptex Investigación Clínica

    Mexico City, 06100

  • Avix Investigacion Clinica S.C.

    Monterrey, 64710

  • Oncológico Potosino

    San Luis Potosí City, 78209

  • FAICIC Clínical Research

    Veracruz, 91900

  • iBiomed - Investigacion Biomedica para el Desarrol

    Zapopan, 45070

Other trials in Mexico

Canada9 sites

  • Cross Cancer Institute

    Edmonton, T6G 1Z2

  • QEII Health Sciences Centre

    Halifax, B3H 1V7

  • Grand River Regional Cancer Centre at Grand River Hospital

    Kitchener, N2G 1G3

  • London Health Sciences Centre

    London, N6A 5W9

  • Jewish General Hospital Department of Medical Oncology

    Montreal, H3T 1E2

  • McGill University Health Centre

    Montreal, H4A 3J1

  • Ottawa Hospital - General Campus

    Ottawa, K1H 8L6

  • Sunnybrook Research Institute

    Toronto, M4N 3M5

  • Mount Sinai Hospital

    Toronto, M5G 1X5

Other trials in Canada

Germany9 sites

  • Helios Klinikum Berlin-Buch

    Berlin, 13125

  • Gynakologisches Zentrum Bonn, Schwerpunkt Gyn. Onkologie,

    Bonn, 53111

  • Klinik Frauenheilkunde, Uniklinik ClO, Studienzentrale

    Cologne, 50937

  • Kliniken Essen-Mitte - Evangelische Huyssens-Stift Breast Unit

    Essen, 45136

  • Universitatsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Nationales Centrum für Tumorerkrankungen - Heidelb

    Heidelberg, 69120

  • Universitätsklinikum Schleswig-Holstein Institut fur Klinische Chermie

    Lübeck, 23538

  • Universitatsklinikum Mannheim GmBH, Frauenklinik

    Mannheim, 68167

  • Universitätsklinikum Tübingen

    Tübingen, 72076

Other trials in Germany

South Korea8 sites

  • National Cancer Center

    Goyang-si Gyeonggi-do, 10408

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 06591

  • Korea University Anam Hospital

    Seoul, 2841

  • Seoul National University Hospital

    Seoul, 3080

Other trials in South Korea

Australia7 sites

  • Cancer Research SA (CRSA)

    Adelaide, South Australia, 5000

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • Saint George Hospital - Australia

    Kogarah, New South Wales, 2217

  • Austin Hospital

    Melbourne, Victoria, 3084

  • Breast Cancer Research Center - Western Australia

    Nedlands, Western Australia, 6009

  • Mater Misericordiae Limited and Mater Research Limited

    South Brisbane, Queensland, 4101

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Belgium7 sites

  • Algemeen Ziekenhuis Klina

    Brasschaat, 2930

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Universitair Ziekenhuis Brussel

    Brussels

  • Grand Hopital de Charleroi - Notre Dame

    Charleroi, 6000

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • UZ Leuven

    Leuven, 3000

  • Centre Hospitalier Universitaire Université Cathol

    Namur, 5000

Other trials in Belgium

Israel7 sites

  • Rambam Health Care Campus

    Haifa, 3109601

  • Hadassah - Hebrew University Medical Center

    Jerusalem

  • Meir Medical Center

    Kfar Saba, 4428164

  • Rabin Medical Center

    Petah Tikva, 4941492

  • Kaplan Medical Center

    Rehovot, 7661041

  • Sheba Medical Center Hospital - Tel Hashomer

    Tel Aviv, 52621

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

Malaysia7 sites

  • Hospital Pulau Pinang

    George Town, 10450

  • Hospital Sultan Ismail

    Johor Bahru, 81100

  • Hospital Kuala Lumpur

    Kuala Lumpur, 47500

  • Pantai Hospital Kuala Lumpur

    Kuala Lumpur, 59100

  • University Malaya Medical Centre (UMMC)

    Kuala Lumpur, 59100

  • Institut Kanser Negara

    Putrajaya, 62250

  • Sarawak General Hospital

    Sarawak, 93586

Other trials in Malaysia

Taiwan7 sites

  • Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

    Hualien City, 970

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Cheng Kung University Hospital

    Tainan, 704

  • Chi Mei Hospital, Lioying

    Tainan, 73657

  • National Taiwan University Hospital

    Taipei, 10048

  • MacKay Medical Foundation The Presbyterian Church in Taiwan MacKay Memorial Hospital

    Taipei, 104217

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan City, 33305

Other trials in Taiwan

Argentina6 sites

  • Hospital Británico de Buenos Aires

    Buenos Aires, 1426

  • Instituto de Oncologia Angel H.Roffo

    CABA, 1417

  • Fundacion CORI para la Investigacion y Prevencion del Cancer

    Capital, F5300COE

  • Instituto de Oncología de Rosario

    Rosario, 2000

  • Centro para la Atencion Integral del Paciente Oncologico Centro Médico C.A.I.P.O

    San Miguel de Tucumán, 4000

  • Clinica Viedma

    Viedma, 8500

Other trials in Argentina

Czechia6 sites

  • Masarykuv onkologicky ustav, klinika komplexni onkologickie pece

    Brno, 65653

  • Fakultni nemocnice Hradec Kravlove, Klinika onkologie a radioterapie

    Hradec Králové, 500 05

  • Fakultní Thomayerova nemocnice

    Hradec Králové, 50005

  • Fakultni nemocnice Olomouc, Onkologicka klinika

    Olomouc, 77520

  • Fakultni nemocnice Karlovske Vinohrady, Radioterapeuticka a onkologicka klinika

    Prague, 100 34

  • Vseobecna Fakultni Nemocnice v Praze

    Prague, 12808

Other trials in Czechia

Chile5 sites

  • Oncovida - Santiago

    Providencia, 7510035

  • Clínica Alemana

    Santiago, 7630000

  • Clínica IRAM

    Santiago

  • Centro de Oncología de Precisión

    Santiago Region, 8330032

  • James Lind Centro de Investigacion del Cancer

    Temuco

Other trials in Chile

Netherlands5 sites

  • Amphia Ziekenhuis - Breda Langendijk

    Breda, 4818 CK

  • Universitair Medisch Centrum Groningen

    Groningen, 9700 RB

  • Medisch Centrum Leeuwarden

    Leeuwarden, 8934 AD

  • Maastricht Universitair Medisch Centrum

    Maastricht, 6229HX

  • Erasmus Medisch Centrum

    Rotterdam

Other trials in Netherlands

Poland5 sites

  • Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

    Gdansk, 80-952

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej

    Gliwice, 44-102

  • SP ZOZ Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego

    Opole, 45-061

  • Mazowiecki Szpital Wojewódzki im. w. Jana Pawa II

    Siedlce, 08-110

  • Narodowy Instytut Onkologii im.Marii Marii Sklodowskiej

    Warsaw, 02-781

Other trials in Poland

Romania4 sites

  • Spitalul Clinic Filantropia

    Bucharest, 11171

  • SC Medisprof SRL

    Cluj-Napoca, 400058

  • Institutal Oncologic, Prof. Dr Ion Chiricuta

    Cluj-Napoca, 400150

  • Centrul De Oncologie Sf Nectarie

    Craiova, 200642

Other trials in Romania

Hong Kong3 sites

  • Queen Mary Hospital

    Hong Kong

  • Tuen Mun Hospital

    Hong Kong

  • Queen Mary Hospital

    Pok Fu Lam, 0

Other trials in Hong Kong

Hungary3 sites

  • Uzsoki Utcai Kornaz, Onkoradiologiai Osztaly

    Budapest, 1145

  • Debreceni Egyetem Klinikai Központ

    Debrecen, 4032

  • Petz Aladar Egyetemi Oktaté Kérhaz - Osztaly

    Győr, 9024

Other trials in Hungary

Slovakia3 sites

  • Onkologicky Ustav Sv. Alzbety

    Bratislava, 81250

  • Národný onkologický ústav

    Bratislava, 83310

  • Nemocnica Partizánske

    Partizánske, 95801

Other trials in Slovakia

South Africa3 sites

  • Hopelands Cancer Centre

    Hilton, 3245

  • Wits Clinical Research

    Johannesburg, 2192

  • The Medical Oncology Centre of Rosebank

    Johannesburg, 2196

Other trials in South Africa

United Kingdom3 sites

  • Leeds Teaching Hospitals NHS Trust

    Leeds, LS9 7TF

  • Barts Health NHS Trust

    London, EC1M 6BQ

  • University College London Hospitals NHS Foundation

    London, WC1E 6BT

Other trials in United Kingdom

Austria2 sites

  • Medizinische Universität Innsbruck

    Innsbruck, 06020

  • Ordensklinikum Linz GmbH Barmherzige Schwestern

    Linz, 4010

Other trials in Austria

Switzerland1 site

  • Kantonsspital St.Gallen

    Sankt Gallen, 9007

Other trials in Switzerland

About this study

Official title: 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

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.

Being tested
Sacituzumab Govitecan-hziy, Paclitaxel, nab-Paclitaxel, Gemcitabine, Carboplatin
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sacituzumab Govitecan-hziyDrug

    Also called IMMU-132, Trodelvy™, GS-0132

    Administered intravenously

  • PaclitaxelDrug

    Administered intravenously

  • nab-PaclitaxelDrug

    Also called Abraxane®

    Administered intravenously

  • GemcitabineDrug

    Administered intravenously

  • CarboplatinDrug

    Administered intravenously

Study groups in NCT05382299
Study groupRoleWhat they receive
Sacituzumab Govitecan-hziy (SG)ExperimentalParticipants will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle.
Receives: Drug: Sacituzumab Govitecan-hziy
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
Receives: Drug: Paclitaxel; Drug: nab-Paclitaxel; Drug: Gemcitabine; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Randomization up to approximately 57 months

Secondary outcomes (8)

  1. Overall Survival (OS)

    OS is defined as the time from the date of randomization until death due to any cause.

    Measured: Randomization up to approximately 57 months

  2. Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1

    ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response.

    Measured: Randomization up to approximately 57 months

  3. Duration of Response (DOR) as Assessed by BICR per RECIST Version 1.1

    DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of definitive PD or death from any cause (whichever comes first).

    Measured: Randomization up to approximately 57 months

  4. Time to Response (TTR) as Assessed by BICR per RECIST Version 1.1

    TTR is defined as the time from the date of randomization until the first documentation of CR or PR.

    Measured: Randomization up to approximately 57 months

  5. Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

    Measured: First dose date up to approximately 57 months plus 30 days

  6. Percentage of Participants Experiencing Clinical Laboratory Abnormalities

    Measured: First dose date up to approximately 57 months plus 30 days

  7. Change from Baseline in the Physical Functioning Domain as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core Questionnaire, Version 3.0 (EORTC QLQ-C30).

    The EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients, it is composed of 30 questions (items) to assess 15 scales; 1 global health status/quality of life (QOL), 5 functional scales (physical, role, cognitive, emotional, and social), and 9 symptom/item scales(fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of function, a high score for the global health status/QOL represents a high QOL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.

    Measured: Randomization up to approximately 57 months

  8. Time to Deterioration (TTD) of Fatigue Scale of the EORTC QLQ-C30

    TTD is defined as the time between the date of randomization and the date of assessment at which a patient experienced a deterioration (≥ 10 points deterioration from baseline in the fatigue scale) or death.

    Measured: Randomization up to approximately 57 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2022
  2. Study start20 Jul 2022
  3. Primary completionJul 2028 (estimated)
  4. Study completionJul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
623 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05382299
Sponsor's protocol ID
GS-US-592-6238
Other IDs
2021-005743-79, DOH-27082022-7958, jRCT2041220122, CTR20234162, 2023-504195-14, 2023
Acronym
ASCENT-03
Status last verified
Apr 2026
First submitted
16 May 2022
Last updated
6 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 41124233

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sacituzumab Govitecan-hziy, Paclitaxel and nab-Paclitaxel in people with Triple Negative Breast Cancer and PD-L1 Negative, run by Gilead Sciences at 363 sites in 30 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 363 sites in United States, China, Japan, Italy, Brazil and 25 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (time frame: Randomization up to approximately 57 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05382299, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.

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