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

NCT ID: NCT05382299

Last Updated: 2025-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

623 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-20

Study Completion Date

2028-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Triple Negative Breast Cancer PD-L1 Negative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sacituzumab Govitecan-hziy (SG)

Participants will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle.

Group Type EXPERIMENTAL

Sacituzumab Govitecan-hziy

Intervention Type DRUG

Administered intravenously

Treatment of Physician's Choice (TPC)

Participants 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

Group Type ACTIVE_COMPARATOR

Paclitaxel

Intervention Type DRUG

Administered intravenously

nab-Paclitaxel

Intervention Type DRUG

Administered intravenously

Gemcitabine

Intervention Type DRUG

Administered intravenously

Carboplatin

Intervention Type DRUG

Administered intravenously

Interventions

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Sacituzumab Govitecan-hziy

Administered intravenously

Intervention Type DRUG

Paclitaxel

Administered intravenously

Intervention Type DRUG

nab-Paclitaxel

Administered intravenously

Intervention Type DRUG

Gemcitabine

Administered intravenously

Intervention Type DRUG

Carboplatin

Administered intravenously

Intervention Type DRUG

Other Intervention Names

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IMMU-132 Trodelvy™ GS-0132 Abraxane®

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gilead Study Director

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

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

Tucson, Arizona, United States

Site Status

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

Tucson, Arizona, United States

Site Status

Arizona Oncology Associates, PC-Hope

Tucson, Arizona, United States

Site Status

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

Tucson, Arizona, United States

Site Status

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

Burbank, California, United States

Site Status

University of California San Diego Moores Cancer

La Jolla, California, United States

Site Status

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

Laguna Hills, California, United States

Site Status

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

San Luis Obispo, California, United States

Site Status

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

Santa Monica, California, United States

Site Status

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

Santa Monica, California, United States

Site Status

University of California Los Angeles - Jonsson Comprehensive Cancer Center

Santa Monica, California, United States

Site Status

Torrance Memorial Physician Network - Cancer Care

Torrance, California, United States

Site Status

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

Westlake Village, California, United States

Site Status

Rocky Mountain Cancer Centers,1700 South Potomac Street

Aurora, Colorado, United States

Site Status

Rocky Mountain Cancer Centers

Boulder, Colorado, United States

Site Status

Rocky Mountain Cancer Centers,2312 N. Nevada Avenue

Colorado Springs, Colorado, United States

Site Status

Rocky Mountain Cancer Centers,6031 E. Woodman Rd.

Colorado Springs, Colorado, United States

Site Status

Rocky Mountain Cancer Centers,4700 E. Hale Parkway

Denver, Colorado, United States

Site Status

Rocky Mountain Cancer Centers,11750 West 2nd Place

Lakewood, Colorado, United States

Site Status

Rocky Mountain Cancer Centers,22 West Dry Creek Circle

Littleton, Colorado, United States

Site Status

Rocky Mountain Cancer Centers,10107 Ridge Gate Parkway

Lone Tree, Colorado, United States

Site Status

Rocky Mountain Cancer Centers,2030 Mountain View Ave Ste 210

Longmont, Colorado, United States

Site Status

Rocky Mountain Cancer Centers,3676 Parker Blvd

Pueblo, Colorado, United States

Site Status

Rocky Mountain Cancer Centers,525 W. 15th Street

Pueblo, Colorado, United States

Site Status

Rocky Mountain Cancer Centers,8820 Huron Street

Thornton, Colorado, United States

Site Status

AdventHealth Medical Group

Altamonte Springs, Florida, United States

Site Status

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

Altamonte Springs, Florida, United States

Site Status

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

Bonita Springs, Florida, United States

Site Status

Florida Cancer Specialists,3630 Manatee Avenue West

Bradenton, Florida, United States

Site Status

Florida Cancer Specialists,5985 Silver Falls Run

Bradenton, Florida, United States

Site Status

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

Brandon, Florida, United States

Site Status

Florida Cancer Specialists,1030 Commerce Creek Blvd

Cape Coral, Florida, United States

Site Status

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

Clearwater, Florida, United States

Site Status

Florida Cancer Specialists

Fort Myers, Florida, United States

Site Status

Florida Cancer Specialists,8981 Colonial Center Drive

Fort Myers, Florida, United States

Site Status

Florida Cancer Specialists,8260 Gladiolus Dr

Fort Myers, Florida, United States

Site Status

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

Gainesville, Florida, United States

Site Status

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

Largo, Florida, United States

Site Status

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

Lecanto, Florida, United States

Site Status

Florida Cancer Specialists,1100 Goodlette Road

Naples, Florida, United States

Site Status

Florida Cancer Specialists,681 4th Avenue North

Naples, Florida, United States

Site Status

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

Ocala, Florida, United States

Site Status

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

Orange City, Florida, United States

Site Status

AdventHealth Medical Group,2501 North Orange Ave

Orlando, Florida, United States

Site Status

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

Orlando, Florida, United States

Site Status

Florida Cancer Specialists,22395 Edgewater Drive

Port Charlotte, Florida, United States

Site Status

Florida Cancer Specialists,600 North Cattlemen Road

Sarasota, Florida, United States

Site Status

Florida Cancer Specialists,1970 Golf Street

Sarasota, Florida, United States

Site Status

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

Spring Hill, Florida, United States

Site Status

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

St. Petersburg, Florida, United States

Site Status

Florida Cancer Specialists - North Region Research Office

St. Petersburg, Florida, United States

Site Status

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

Tampa, Florida, United States

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

Tavares, Florida, United States

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

The Villages, Florida, United States

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

Trinity, Florida, United States

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Florida Cancer Specialists,901 South Tamiami Trail

Venice, Florida, United States

Site Status

Florida Cancer Specialists,836 Sunset Lake Blvd

Venice, Florida, United States

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

Winter Park, Florida, United States

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Northside Hospital,125 King Avenue

Athens, Georgia, United States

Site Status

Northside Hospital,5670 Peachtree Dunwoody Rd.

Atlanta, Georgia, United States

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Northside Hospital

Atlanta, Georgia, United States

Site Status

Northside Hospital,308 Deep South Farm Rd, Suite 200

Blairsville, Georgia, United States

Site Status

Northside Hospital,228 Riverstone Dr.

Canton, Georgia, United States

Site Status

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

Carrollton, Georgia, United States

Site Status

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

Cartersville, Georgia, United States

Site Status

Northside Hospital,1505 Northside Blvd, Suite 4600

Cumming, Georgia, United States

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Northside Hospital,3855 Pleasant Hill Rd., Suite 480

Duluth, Georgia, United States

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Northside Hospital,308 Coliseum Dr.

Macon, Georgia, United States

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Northwest Georgia Oncology Northwest Georgia Oncology Centers, PCCenters, PC

Marietta, Georgia, United States

Site Status

Robert H. Lurie Comprehensive Cancer Center of Northwestern University

Chicago, Illinois, United States

Site Status

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

DeKalb, Illinois, United States

Site Status

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

DeKalb, Illinois, United States

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

Geneva, Illinois, United States

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

Geneva, Illinois, United States

Site Status

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

Lake Forest, Illinois, United States

Site Status

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

Warrenville, Illinois, United States

Site Status

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

Warrenville, Illinois, United States

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

Winfield, Illinois, United States

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University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

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

Louisville, Kentucky, United States

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

Louisville, Kentucky, United States

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Norton Cancer Institute - Saint Matthews

Louisville, Kentucky, United States

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Norton Cancer Institute - Saint Matthews,4955 Norton Healthcare Blvd

Louisville, Kentucky, United States

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Cancer Institute Ascension Saint Agnes

Baltimore, Maryland, United States

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Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

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Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

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

Southaven, Mississippi, United States

Site Status

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

Babylon, New York, United States

Site Status

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

New Hyde Park, New York, United States

Site Status

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

Patchogue, New York, United States

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

Port Jefferson, New York, United States

Site Status

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

Port Jefferson Station, New York, United States

Site Status

New York Cancer & Blood Specialists - Port Jeffers

Port Jefferson Station, New York, United States

Site Status

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

Riverhead, New York, United States

Site Status

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

The Bronx, New York, United States

Site Status

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

The Bronx, New York, United States

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

Charlotte, North Carolina, United States

Site Status

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

Wilmington, North Carolina, United States

Site Status

Novant Health Cancer Institute - Forsyth

Winston-Salem, North Carolina, United States

Site Status

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

Erie, Pennsylvania, United States

Site Status

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

Erie, Pennsylvania, United States

Site Status

Magee-Womens Hospital of UPMC,4300 Londonberry Road

Harrisburg, Pennsylvania, United States

Site Status

Magee-Womens Hospital of UPMC,2035 Technology Parkway

Mechanicsburg, Pennsylvania, United States

Site Status

University of Pennsylvania Abramson Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, United States

Site Status

Magee-Womens Hospital of UPMC,5115 Centre Avenue

Pittsburgh, Pennsylvania, United States

Site Status

Magee-Womens Hospital of UPMC,1703 Innovation Drive

York, Pennsylvania, United States

Site Status

Tennessee Oncology, PLLC,103 Natchez Park Drive

Dickson, Tennessee, United States

Site Status

Tennessee Oncology, PLLC,4488 Carothers Parkway

Franklin, Tennessee, United States

Site Status

Tennessee Oncology, PLLC,225 Big Station Camp Blvd

Gallatin, Tennessee, United States

Site Status

The West Clinic, PLLC dba West Cancer Center

Germantown, Tennessee, United States

Site Status

Tennessee Oncology, PLLC,353 New Shackle Island Road

Hendersonville, Tennessee, United States

Site Status

Tennessee Oncology, PLLC,5653 First Blvd.

Hermitage, Tennessee, United States

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Tennessee Oncology, PLLC,103 Physicians Way

Lebanon, Tennessee, United States

Site Status

Tennessee Oncology, PLLC,1840 Medical Center Parkway

Murfreesboro, Tennessee, United States

Site Status

Tennessee Oncology, PLLC,2004 Hayes Street

Nashville, Tennessee, United States

Site Status

Tennessee Oncology, PLLC,SCRI Oncology Partners

Nashville, Tennessee, United States

Site Status

Tennessee Oncology, PLLC

Nashville, Tennessee, United States

Site Status

Tennessee Oncology, PLLC,4220 Harding Rd

Nashville, Tennessee, United States

Site Status

Tennessee Oncology, PLLC,3443 Dickerson Road

Nashville, Tennessee, United States

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Tennessee Oncology, PLLC,397 Wallace Road

Nashville, Tennessee, United States

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Tennessee Oncology, PLLC,120 Frank Martin Road

Shelbyville, Tennessee, United States

Site Status

Tennessee Oncology, PLLC,300 Stonecrest Blvd

Smyrna, Tennessee, United States

Site Status

Texas Oncology PA,901 West 38th Street

Austin, Texas, United States

Site Status

Texas Oncology PA

Austin, Texas, United States

Site Status

Texas Oncology PA,4101 James Casey, Suite 100

Austin, Texas, United States

Site Status

Virginia Oncology Associates,744 N. Battlefield Blvd

Chesapeake, Virginia, United States

Site Status

Virginia Oncology Associates,1051 Loftis Blvd Suite 100

Newport News, Virginia, United States

Site Status

Virginia Oncology Associates

Norfolk, Virginia, United States

Site Status

Virginia Oncology Associates,1950 Glenn Mitchell Drive

Virginia Beach, Virginia, United States

Site Status

Hospital Británico de Buenos Aires

Buenos Aires, , Argentina

Site Status

Instituto de Oncologia Angel H.Roffo

CABA, , Argentina

Site Status

Fundacion CORI para la Investigacion y Prevencion del Cancer

Capital, , Argentina

Site Status

Instituto de Oncología de Rosario

Rosario, , Argentina

Site Status

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

San Miguel de Tucumán, , Argentina

Site Status

Clinica Viedma

Viedma, , Argentina

Site Status

Saint George Hospital - Australia

Kogarah, New South Wales, Australia

Site Status

Mater Misericordiae Limited and Mater Research Limited

South Brisbane, Queensland, Australia

Site Status

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Site Status

Cancer Research SA (CRSA)

Adelaide, South Australia, Australia

Site Status

Monash Medical Centre

Clayton, Victoria, Australia

Site Status

Austin Hospital

Melbourne, Victoria, Australia

Site Status

Breast Cancer Research Center - Western Australia

Nedlands, Western Australia, Australia

Site Status

Medizinische Universität Innsbruck

Innsbruck, , Austria

Site Status

Ordensklinikum Linz GmbH Barmherzige Schwestern

Linz, , Austria

Site Status

Algemeen Ziekenhuis Klina

Brasschaat, , Belgium

Site Status

Cliniques Universitaires Saint-Luc

Brussels, , Belgium

Site Status

Universitair Ziekenhuis Brussel

Brussels, , Belgium

Site Status

Grand Hopital de Charleroi - Notre Dame

Charleroi, , Belgium

Site Status

Universitair Ziekenhuis Gent

Ghent, , Belgium

Site Status

UZ Leuven

Leuven, , Belgium

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Centre Hospitalier Universitaire Université Cathol

Namur, , Belgium

Site Status

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

Goiânia, , Brazil

Site Status

ONCOSITE - Centro de Pesquisa Clinica em Oncologia

Ijuí, , Brazil

Site Status

Catarina Pesquisa Clínica

Itajaí, , Brazil

Site Status

Hospital Moinhos de Vento

Porto Alegre, , Brazil

Site Status

Hospital de Clinicas de Porto Alegre - HCPA

Porto Alegre, , Brazil

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Hospital Sao Lucas da PUCRS

Porto Alegre, , Brazil

Site Status

Instituto Nacional de Câncer - INCA - HCIII

Rio de Janeiro, , Brazil

Site Status

Núcleo de Oncologia da Bahia

Salvador, , Brazil

Site Status

CEPHO - Centro de Estudos e PesquisaS de Hematologia e Oncologia

Santo André, , Brazil

Site Status

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

São Paulo, , Brazil

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Clinica de Pesquisas e Centro de Estudos em Oncolo

São Paulo, , Brazil

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Fundação Pio XII - Hospital de Amor de Barretos

São Paulo, , Brazil

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Hospital Amaral Carvalho

São Paulo, , Brazil

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Nucleo de Pesquisa Clinica da Rede Sao Camilo

São Paulo, , Brazil

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Cross Cancer Institute

Edmonton, , Canada

Site Status

QEII Health Sciences Centre

Halifax, , Canada

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Grand River Regional Cancer Centre at Grand River Hospital

Kitchener, , Canada

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London Health Sciences Centre

London, , Canada

Site Status

Jewish General Hospital Department of Medical Oncology

Montreal, , Canada

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McGill University Health Centre

Montreal, , Canada

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Ottawa Hospital - General Campus

Ottawa, , Canada

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Sunnybrook Research Institute

Toronto, , Canada

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Mount Sinai Hospital

Toronto, , Canada

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Oncovida - Santiago

Providencia, , Chile

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Clínica Alemana

Santiago, , Chile

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Clínica IRAM

Santiago, , Chile

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Centro de Oncología de Precisión

Santiago Region, , Chile

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James Lind Centro de Investigacion del Cancer

Temuco, , Chile

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Cancer Hospital Chinese Academy of Medical Sciences

Beijing, , China

Site Status

Peking University People's Hospital

Beijing, , China

Site Status

Beijing Cancer Hospital

Beijing, , China

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The First Medical Center of Chinese PLA General Hospital

Beijing, , China

Site Status

The Second Xiangya Hospital of Central South University

Changsha, , China

Site Status

Sichuan Cancer Hospital

Chengdu, , China

Site Status

West China Hospital, Sichuan University

Chengdu, , China

Site Status

The First Affiliated Hospital of Chongqing Medical University

Chongqing, , China

Site Status

Chongqing University Cancer Hospital

Chongqing, , China

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Deyang People's Hospital

Deyang, , China

Site Status

Sun Yat-Sen University Cancer Center

Guangzhou, , China

Site Status

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, , China

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Harbin Medical University Cancer Hospital

Harbin, , China

Site Status

Anhui Provincial Cancer Hospital

Hefei, , China

Site Status

The Second Hospital of Anhui Medical University

Hefei, , China

Site Status

The Second Hospital of Jilin University

Jilin Sheng, , China

Site Status

The Second Hospital of Shandong University

Jinan, , China

Site Status

Shandong Cancer Hospital

Jinan, , China

Site Status

Nanchang People's hospital

Nanchang, , China

Site Status

The First Affiliated Hospital of Guangxi Medical University

Nanning, , China

Site Status

Tianjin Medical University Cancer Institute& Hospital

Tianjin, , China

Site Status

Weihai Municipal Hospital

Weihai, , China

Site Status

Hubei Cancer Hospital

Wuhan, , China

Site Status

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

Wuhan, , China

Site Status

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

Wuhan, , China

Site Status

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, , China

Site Status

The Second Affiliated Hospital of Zhejiang University School of Medicine

Zhejiang, , China

Site Status

The First Affiliated Hospital of Wenzhou Medical University

Zhejiang, , China

Site Status

Masarykuv onkologicky ustav, klinika komplexni onkologickie pece

Brno, , Czechia

Site Status

Fakultni nemocnice Hradec Kravlove, Klinika onkologie a radioterapie

Hradec Králové, , Czechia

Site Status

Fakultní Thomayerova nemocnice

Hradec Králové, , Czechia

Site Status

Fakultni nemocnice Olomouc, Onkologicka klinika

Olomouc, , Czechia

Site Status

Fakultni nemocnice Karlovske Vinohrady, Radioterapeuticka a onkologicka klinika

Prague, , Czechia

Site Status

Vseobecna Fakultni Nemocnice v Praze

Prague, , Czechia

Site Status

Sainte Catherine Institut du Cancer Avignon Provence

Avignon, , France

Site Status

Centre Hospitalier Régional et Universitaire de Be

Besançon, , France

Site Status

Hôpital Morvan, Institut de cancérologie

Brest, , France

Site Status

Centre francois Baclesse

Caen, , France

Site Status

Centre Jean Perrin

Clermont-Ferrand, , France

Site Status

Centre de Cancérologie du Grand Montpellier

Montpellier, , France

Site Status

Hôpital Privé du Confluent

Nantes, , France

Site Status

Hospices Civils de Lyon Hôpital Lyon Sud

Pierre-Bénite, , France

Site Status

Centre Armoricain de Radiothérapie, dImagerie Méd

Plérin, , France

Site Status

Centre Eugène Marquis

Rennes, , France

Site Status

Institut Claudius Regaud - IUCT-O

Toulouse, , France

Site Status

Institut Gustave Roussy

Villejuif, , France

Site Status

Helios Klinikum Berlin-Buch

Berlin, , Germany

Site Status

Gynakologisches Zentrum Bonn, Schwerpunkt Gyn. Onkologie,

Bonn, , Germany

Site Status

Klinik Frauenheilkunde, Uniklinik ClO, Studienzentrale

Cologne, , Germany

Site Status

Kliniken Essen-Mitte - Evangelische Huyssens-Stift Breast Unit

Essen, , Germany

Site Status

Universitatsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Site Status

Nationales Centrum für Tumorerkrankungen - Heidelb

Heidelberg, , Germany

Site Status

Universitätsklinikum Schleswig-Holstein Institut fur Klinische Chermie

Lübeck, , Germany

Site Status

Universitatsklinikum Mannheim GmBH, Frauenklinik

Mannheim, , Germany

Site Status

Universitätsklinikum Tübingen

Tübingen, , Germany

Site Status

Queen Mary Hospital

Hong Kong, , Hong Kong

Site Status

Tuen Mun Hospital

Hong Kong, , Hong Kong

Site Status

Queen Mary Hospital

Pok Fu Lam, , Hong Kong

Site Status

Uzsoki Utcai Kornaz, Onkoradiologiai Osztaly

Budapest, , Hungary

Site Status

Debreceni Egyetem Klinikai Központ

Debrecen, , Hungary

Site Status

Petz Aladar Egyetemi Oktaté Kérhaz - Osztaly

Győr, , Hungary

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Rambam Health Care Campus

Haifa, , Israel

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Hadassah - Hebrew University Medical Center

Jerusalem, , Israel

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Meir Medical Center

Kfar Saba, , Israel

Site Status

Rabin Medical Center

Petah Tikva, , Israel

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Kaplan Medical Center

Rehovot, , Israel

Site Status

Sheba Medical Center Hospital - Tel Hashomer

Tel Aviv, , Israel

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Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status

IRCCS Istituto Tumori "G.Paolo II"

Bari, , Italy

Site Status

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

Bologna, , Italy

Site Status

UO Oncologia, ASST degli Spedali Civili di Brescia

Brescia, , Italy

Site Status

IRCSS Ospedale Policlinico San Martino

Genova GE, , Italy

Site Status

S.C. Oncologia medica, ASST di Lecco

Lecco, , Italy

Site Status

Presidio Ospedaliero di Lucca

Lucca, , Italy

Site Status

Ospedale Generale Provinciale - Macerata

Macerata, , Italy

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Istituto Europeo di Oncologia

Milan, , Italy

Site Status

Fondazione IRCCS - Istituto Nazionale dei Tumori

Milan, , Italy

Site Status

Azienda Socio Sanitaria Territoriale

Monza, , Italy

Site Status

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

Napoli, , Italy

Site Status

Azienda Ospedaliero-Universitaria Maggiore della C

Novara, , Italy

Site Status

Istituto Oncologico Veneto - IRCCS

Padua, , Italy

Site Status

AOU Policlinico Umberto I

Roma, , Italy

Site Status

Fondazione Policlinico Universitario Agostino Geme

Rome, , Italy

Site Status

Aichi Cancer Center Hospital

Aichi, , Japan

Site Status

Juntendo University Hospital

Bunkyō City, , Japan

Site Status

Chiba Cancer Center

Chūōku, , Japan

Site Status

Shikoku Cancer Center

Ehime, , Japan

Site Status

Hakuaikai Sagara Hospital

Kagoshima, , Japan

Site Status

National Cancer Center Hospital East

Kashiwa, , Japan

Site Status

Cancer Institute Hospital of JFCR

Kōtoku, , Japan

Site Status

Kumamoto University Hospital

Kumamoto, , Japan

Site Status

Kure Medical Center And Chugoku Cancer Center

Kure, , Japan

Site Status

National Hospital Organization Kyushu Cancer Center

Minamiku, , Japan

Site Status

Nagoya University Hospital

Nagoya, , Japan

Site Status

Hiroshima City Hiroshima Citizens Hospital

Nakaku, , Japan

Site Status

Okayama University Hospital

Okayama, , Japan

Site Status

Kyoto University Hospital

Sakyo-ku, , Japan

Site Status

Hokkaido Cancer Center

Sapporo, , Japan

Site Status

Shizuoka Cancer Center

Shizuoka, , Japan

Site Status

Shizuoka General Hospital

Shizuoka, , Japan

Site Status

Osaka University Hospital

Suita, , Japan

Site Status

Showa University Hospital

Tokyo, , Japan

Site Status

Kanagawa Cancer Center

Yokohama, , Japan

Site Status

Hospital Pulau Pinang

George Town, , Malaysia

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Hospital Sultan Ismail

Johor Bahru, , Malaysia

Site Status

Hospital Kuala Lumpur

Kuala Lumpur, , Malaysia

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Pantai Hospital Kuala Lumpur

Kuala Lumpur, , Malaysia

Site Status

University Malaya Medical Centre (UMMC)

Kuala Lumpur, , Malaysia

Site Status

Institut Kanser Negara

Putrajaya, , Malaysia

Site Status

Sarawak General Hospital

Sarawak, , Malaysia

Site Status

Icaro Investigaciones en Medicina

Chihuahua City, , Mexico

Site Status

Sinacor - Centro para el Desarrollo de la Medicina

Culiacán, , Mexico

Site Status

Panamerican Clinical Research Mexico - Guadalajara

Guadalajara, , Mexico

Site Status

Cryptex Investigación Clínica

Mexico City, , Mexico

Site Status

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

Mérida, , Mexico

Site Status

Fucam A.C.

México, , Mexico

Site Status

Avix Investigacion Clinica S.C.

Monterrey, , Mexico

Site Status

Oncológico Potosino

San Luis Potosí City, , Mexico

Site Status

FAICIC Clínical Research

Veracruz, , Mexico

Site Status

iBiomed - Investigacion Biomedica para el Desarrol

Zapopan, , Mexico

Site Status

Amphia Ziekenhuis - Breda Langendijk

Breda, , Netherlands

Site Status

Universitair Medisch Centrum Groningen

Groningen, , Netherlands

Site Status

Medisch Centrum Leeuwarden

Leeuwarden, , Netherlands

Site Status

Maastricht Universitair Medisch Centrum

Maastricht, , Netherlands

Site Status

Erasmus Medisch Centrum

Rotterdam, , Netherlands

Site Status

Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

Gdansk, , Poland

Site Status

Narodowy Instytut Onkologii im. Marii Sklodowskiej

Gliwice, , Poland

Site Status

SP ZOZ Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego

Opole, , Poland

Site Status

Mazowiecki Szpital Wojewódzki im. w. Jana Pawa II

Siedlce, , Poland

Site Status

Narodowy Instytut Onkologii im.Marii Marii Sklodowskiej

Warsaw, , Poland

Site Status

Spitalul Clinic Filantropia

Bucharest, , Romania

Site Status

SC Medisprof SRL

Cluj-Napoca, , Romania

Site Status

Institutal Oncologic, Prof. Dr Ion Chiricuta

Cluj-Napoca, , Romania

Site Status

Centrul De Oncologie Sf Nectarie

Craiova, , Romania

Site Status

Onkologicky Ustav Sv. Alzbety

Bratislava, , Slovakia

Site Status

Národný onkologický ústav

Bratislava, , Slovakia

Site Status

Nemocnica Partizánske

Partizánske, , Slovakia

Site Status

Hopelands Cancer Centre

Hilton, , South Africa

Site Status

Wits Clinical Research

Johannesburg, , South Africa

Site Status

The Medical Oncology Centre of Rosebank

Johannesburg, , South Africa

Site Status

National Cancer Center

Goyang-si Gyeonggi-do, , South Korea

Site Status

Seoul National University Bundang Hospital

Seongnam-si, , South Korea

Site Status

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

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

Seoul, , South Korea

Site Status

Korea University Anam Hospital

Seoul, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Hospital Teresa Herrera - Materno Infantil

A Coruña, , Spain

Site Status

Hospital Universitari Dexeus

Barcelona, , Spain

Site Status

Hospital Universitari Vall d'Hebrón

Barcelona, , Spain

Site Status

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status

Hospital Universitario de Basurto

Bilbao, , Spain

Site Status

Hospital Universitari Arnau de Vilanova

Lleida, , Spain

Site Status

Hospital General Universitario Gregorio Maranon

Madrid, , Spain

Site Status

MD Anderson Cancer Center Madrid

Madrid, , Spain

Site Status

Hospital Universitario Fundación Jiménez Díaz

Madrid, , Spain

Site Status

Hospital General Universitario Morales Meseguer

Murcia, , Spain

Site Status

Hospital Unviersitario Virgen del Rocio

Seville, , Spain

Site Status

Hospital Universitario Virgen Macarena

Seville, , Spain

Site Status

Hospital Clínico Universitario de Valencia

Valencia, , Spain

Site Status

Kantonsspital St.Gallen

Sankt Gallen, , Switzerland

Site Status

Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Hualien City, , Taiwan

Site Status

Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status

National Cheng Kung University Hospital

Tainan City, , Taiwan

Site Status

Chi Mei Hospital, Lioying

Tainan City, , Taiwan

Site Status

National Taiwan University Hospital

Taipei, , Taiwan

Site Status

MacKay Medical Foundation The Presbyterian Church in Taiwan MacKay Memorial Hospital

Taipei, , Taiwan

Site Status

Chang Gung Memorial Hospital, Linkou

Taoyuan, , Taiwan

Site Status

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

Adana, , Turkey (Türkiye)

Site Status

Memorial Ankara Hastanesi

Ankara, , Turkey (Türkiye)

Site Status

Ankara Il Saglik Mudurlugu SBU Gulhane Egitim Ve A

Ankara, , Turkey (Türkiye)

Site Status

Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

Ankara, , Turkey (Türkiye)

Site Status

Hacettepe Üniversitesi Hastanesi

Ankara, , Turkey (Türkiye)

Site Status

Trakya Universitesi Tip Fakultesi Hastanesi

Edirne, , Turkey (Türkiye)

Site Status

Istanbul Il Saglik Mudurlugu Goztepe Prof. Dr. Sul

Istanbul, , Turkey (Türkiye)

Site Status

Medipol Mega Universite Hastanesi

Istanbul, , Turkey (Türkiye)

Site Status

Ege Universitesi Hastanesi

Izmir, , Turkey (Türkiye)

Site Status

Medicana International Izmir Hastanesi

Izmir, , Turkey (Türkiye)

Site Status

Acibadem Maslak Hastanesi

Sarıyer, , Turkey (Türkiye)

Site Status

Leeds Teaching Hospitals NHS Trust

Leeds, , United Kingdom

Site Status

Barts Health NHS Trust

London, , United Kingdom

Site Status

University College London Hospitals NHS Foundation

London, , United Kingdom

Site Status

Countries

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United States Argentina Australia Austria Belgium Brazil Canada Chile China Czechia France Germany Hong Kong Hungary Israel Italy Japan Malaysia Mexico Netherlands Poland Romania Slovakia South Africa South Korea Spain Switzerland Taiwan Turkey (Türkiye) United Kingdom

References

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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 Oct 19. doi: 10.1056/NEJMoa2511734. Online ahead of print.

Reference Type DERIVED
PMID: 41124233 (View on PubMed)

Related Links

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Other Identifiers

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2021-005743-79

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

DOH-27082022-7958

Identifier Type: REGISTRY

Identifier Source: secondary_id

jRCT2041220122

Identifier Type: REGISTRY

Identifier Source: secondary_id

CTR20234162

Identifier Type: REGISTRY

Identifier Source: secondary_id

2023-504195-14

Identifier Type: OTHER

Identifier Source: secondary_id

GS-US-592-6238

Identifier Type: -

Identifier Source: org_study_id

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