Study Details

OVERVIEW

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 (ASCENT-03)

PROTOCOL 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.

Participation Requirements

Age

18 Years +

Sex

ALL

Healthy Volunteers

Medical Condition

Triple Negative Breast Cancer, PD-L1 Negative

Gender

N/A

Date

July 2022 - July 2028

Study Type

INTERVENTIONAL

Study Phase

PHASE3

Product

Sacituzumab Govitecan-hziy, Paclitaxel, nab-Paclitaxel, Gemcitabine, Carboplatin

Eligibility Information

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

Locations

Locations (363)

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

Tucson, Arizona, United States, 85704

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

Tucson, Arizona, United States, 85704

Arizona Oncology Associates, PC-Hope

Tucson, Arizona, United States, 85711

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

Tucson, Arizona, United States, 85745

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

Burbank, California, United States, 91505

University of California San Diego Moores Cancer

La Jolla, California, United States, 92093

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

Laguna Hills, California, United States, 91505

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

San Luis Obispo, California, United States, 93401

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

Santa Monica, California, United States, 90404

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

Santa Monica, California, United States, 90404

University of California Los Angeles - Jonsson Comprehensive Cancer Center

Santa Monica, California, United States, 90404

Torrance Memorial Physician Network - Cancer Care

Torrance, California, United States, 90505

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

Westlake Village, California, United States, 91361

Rocky Mountain Cancer Centers,1700 South Potomac Street

Aurora, Colorado, United States, 80012

Rocky Mountain Cancer Centers

Boulder, Colorado, United States, 80303

Rocky Mountain Cancer Centers,2312 N. Nevada Avenue

Colorado Springs, Colorado, United States, 80907

Rocky Mountain Cancer Centers,6031 E. Woodman Rd.

Colorado Springs, Colorado, United States, 80923

Rocky Mountain Cancer Centers,4700 E. Hale Parkway

Denver, Colorado, United States, 80220

Rocky Mountain Cancer Centers,11750 West 2nd Place

Lakewood, Colorado, United States, 80228

Rocky Mountain Cancer Centers,22 West Dry Creek Circle

Littleton, Colorado, United States, 80120

Rocky Mountain Cancer Centers,10107 Ridge Gate Parkway

Lone Tree, Colorado, United States, 80124

Rocky Mountain Cancer Centers,2030 Mountain View Ave Ste 210

Longmont, Colorado, United States, 80124

Rocky Mountain Cancer Centers,3676 Parker Blvd

Pueblo, Colorado, United States, 81008

Rocky Mountain Cancer Centers,525 W. 15th Street

Pueblo, Colorado, United States, 81008

Rocky Mountain Cancer Centers,8820 Huron Street

Thornton, Colorado, United States, 80260

AdventHealth Medical Group

Altamonte Springs, Florida, United States, 32701

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

Altamonte Springs, Florida, United States, 32701

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

Bonita Springs, Florida, United States, 34135

Florida Cancer Specialists,3630 Manatee Avenue West

Bradenton, Florida, United States, 34205

Florida Cancer Specialists,5985 Silver Falls Run

Bradenton, Florida, United States, 34211

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

Brandon, Florida, United States, 33511

Florida Cancer Specialists,1030 Commerce Creek Blvd

Cape Coral, Florida, United States, 33909

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

Clearwater, Florida, United States, 33761

Florida Cancer Specialists

Fort Myers, Florida, United States, 33901

Florida Cancer Specialists,8981 Colonial Center Drive

Fort Myers, Florida, United States, 33905

Florida Cancer Specialists,8260 Gladiolus Dr

Fort Myers, Florida, United States, 33908

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

Gainesville, Florida, United States, 32605

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

Largo, Florida, United States, 33770

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

Lecanto, Florida, United States, 34461

Florida Cancer Specialists,1100 Goodlette Road

Naples, Florida, United States, 34102

Florida Cancer Specialists,681 4th Avenue North

Naples, Florida, United States, 34102

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

Ocala, Florida, United States, 34474

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

Orange City, Florida, United States, 32763

AdventHealth Medical Group,2501 North Orange Ave

Orlando, Florida, United States, 32804

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

Orlando, Florida, United States, 32806

Florida Cancer Specialists,22395 Edgewater Drive

Port Charlotte, Florida, United States, 33980

Florida Cancer Specialists,600 North Cattlemen Road

Sarasota, Florida, United States, 34232

Florida Cancer Specialists,1970 Golf Street

Sarasota, Florida, United States, 34236

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

Spring Hill, Florida, United States, 34608

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

St. Petersburg, Florida, United States, 33705

Florida Cancer Specialists - North Region Research Office

St. Petersburg, Florida, United States, 33705

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

Tampa, Florida, United States, 33607

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

Tavares, Florida, United States, 32778

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

The Villages, Florida, United States, 32159

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

Trinity, Florida, United States, 34655

Florida Cancer Specialists,901 South Tamiami Trail

Venice, Florida, United States, 34285

Florida Cancer Specialists,836 Sunset Lake Blvd

Venice, Florida, United States, 34292

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

Winter Park, Florida, United States, 32789

Northside Hospital,125 King Avenue

Athens, Georgia, United States, 30606

Northside Hospital,5670 Peachtree Dunwoody Rd.

Atlanta, Georgia, United States, 30342

Northside Hospital

Atlanta, Georgia, United States, 30342

Northside Hospital,308 Deep South Farm Rd, Suite 200

Blairsville, Georgia, United States, 30512

Northside Hospital,228 Riverstone Dr.

Canton, Georgia, United States, 30114

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

Carrollton, Georgia, United States, 30117

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

Cartersville, Georgia, United States, 30121

Northside Hospital,1505 Northside Blvd, Suite 4600

Cumming, Georgia, United States, 30041

Northside Hospital,3855 Pleasant Hill Rd., Suite 480

Duluth, Georgia, United States, 30096

Northside Hospital,308 Coliseum Dr.

Macon, Georgia, United States, 31217

Northwest Georgia Oncology Northwest Georgia Oncology Centers, PCCenters, PC

Marietta, Georgia, United States, 30060

Robert H. Lurie Comprehensive Cancer Center of Northwestern University

Chicago, Illinois, United States, 60611

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

DeKalb, Illinois, United States, 60115

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

DeKalb, Illinois, United States, 60115

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

Geneva, Illinois, United States, 60134

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

Geneva, Illinois, United States, 60134

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

Lake Forest, Illinois, United States, 60045

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

Warrenville, Illinois, United States, 25731

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

Warrenville, Illinois, United States, 60555

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

Winfield, Illinois, United States, 60190

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States, 52242

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

Louisville, Kentucky, United States, 40202

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

Louisville, Kentucky, United States, 40202

Norton Cancer Institute - Saint Matthews

Louisville, Kentucky, United States, 40207

Norton Cancer Institute - Saint Matthews,4955 Norton Healthcare Blvd

Louisville, Kentucky, United States, 40241

Cancer Institute Ascension Saint Agnes

Baltimore, Maryland, United States, 21229

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

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

Southaven, Mississippi, United States, 38671

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

Babylon, New York, United States, 11702

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

New Hyde Park, New York, United States, 11042

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

Patchogue, New York, United States, 11772

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

Port Jefferson, New York, United States, 11776

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

Port Jefferson Station, New York, United States, 11776

New York Cancer & Blood Specialists - Port Jeffers

Port Jefferson Station, New York, United States, 11776

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

Riverhead, New York, United States, 11901

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

The Bronx, New York, United States, 10028

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

The Bronx, New York, United States, 10469

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

Charlotte, North Carolina, United States, 28204

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

Wilmington, North Carolina, United States, 28401

Novant Health Cancer Institute - Forsyth

Winston-Salem, North Carolina, United States, 27103

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

Erie, Pennsylvania, United States, 16505

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

Erie, Pennsylvania, United States, 16550

Magee-Womens Hospital of UPMC,4300 Londonberry Road

Harrisburg, Pennsylvania, United States, 17109

Magee-Womens Hospital of UPMC,2035 Technology Parkway

Mechanicsburg, Pennsylvania, United States, 17050

University of Pennsylvania Abramson Cancer Center

Philadelphia, Pennsylvania, United States, 19104

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, United States, 15213

Magee-Womens Hospital of UPMC,5115 Centre Avenue

Pittsburgh, Pennsylvania, United States, 15232

Magee-Womens Hospital of UPMC,1703 Innovation Drive

York, Pennsylvania, United States, 17408

Tennessee Oncology, PLLC,103 Natchez Park Drive

Dickson, Tennessee, United States, 37055

Tennessee Oncology, PLLC,4488 Carothers Parkway

Franklin, Tennessee, United States, 37067

Tennessee Oncology, PLLC,225 Big Station Camp Blvd

Gallatin, Tennessee, United States, 37066

The West Clinic, PLLC dba West Cancer Center

Germantown, Tennessee, United States, 38138

Tennessee Oncology, PLLC,353 New Shackle Island Road

Hendersonville, Tennessee, United States, 37075

Tennessee Oncology, PLLC,5653 First Blvd.

Hermitage, Tennessee, United States, 37076

Tennessee Oncology, PLLC,103 Physicians Way

Lebanon, Tennessee, United States, 37090

Tennessee Oncology, PLLC,1840 Medical Center Parkway

Murfreesboro, Tennessee, United States, 37129

Tennessee Oncology, PLLC,2004 Hayes Street

Nashville, Tennessee, United States, 37203

Tennessee Oncology, PLLC,SCRI Oncology Partners

Nashville, Tennessee, United States, 37203

Tennessee Oncology, PLLC

Nashville, Tennessee, United States, 37203

Tennessee Oncology, PLLC,4220 Harding Rd

Nashville, Tennessee, United States, 37205

Tennessee Oncology, PLLC,3443 Dickerson Road

Nashville, Tennessee, United States, 37207

Tennessee Oncology, PLLC,397 Wallace Road

Nashville, Tennessee, United States, 37211

Tennessee Oncology, PLLC,120 Frank Martin Road

Shelbyville, Tennessee, United States, 37160

Tennessee Oncology, PLLC,300 Stonecrest Blvd

Smyrna, Tennessee, United States, 37167

Texas Oncology PA,901 West 38th Street

Austin, Texas, United States, 78705

Texas Oncology PA

Austin, Texas, United States, 78731

Texas Oncology PA,4101 James Casey, Suite 100

Austin, Texas, United States, 78745

Virginia Oncology Associates,744 N. Battlefield Blvd

Chesapeake, Virginia, United States, 23320

Virginia Oncology Associates,1051 Loftis Blvd Suite 100

Newport News, Virginia, United States, 23606

Virginia Oncology Associates

Norfolk, Virginia, United States, 23502

Virginia Oncology Associates,1950 Glenn Mitchell Drive

Virginia Beach, Virginia, United States, 23456

Hospital Británico de Buenos Aires

Buenos Aires, Argentina, 1426

Instituto de Oncologia Angel H.Roffo

CABA, Argentina, 1417

Fundacion CORI para la Investigacion y Prevencion del Cancer

Capital, Argentina, F5300COE

Instituto de Oncología de Rosario

Rosario, Argentina, 2000

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

San Miguel de Tucumán, Argentina, 4000

Clinica Viedma

Viedma, Argentina, 8500

Saint George Hospital - Australia

Kogarah, New South Wales, Australia, 2217

Mater Misericordiae Limited and Mater Research Limited

South Brisbane, Queensland, Australia, 4101

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia, 4102

Cancer Research SA (CRSA)

Adelaide, South Australia, Australia, 5000

Monash Medical Centre

Clayton, Victoria, Australia, 3168

Austin Hospital

Melbourne, Victoria, Australia, 3084

Breast Cancer Research Center - Western Australia

Nedlands, Western Australia, Australia, 6009

Medizinische Universität Innsbruck

Innsbruck, Austria, 06020

Ordensklinikum Linz GmbH Barmherzige Schwestern

Linz, Austria, 4010

Algemeen Ziekenhuis Klina

Brasschaat, Belgium, 2930

Cliniques Universitaires Saint-Luc

Brussels, Belgium, 1200

Universitair Ziekenhuis Brussel

Brussels, Belgium

Grand Hopital de Charleroi - Notre Dame

Charleroi, Belgium, 6000

Universitair Ziekenhuis Gent

Ghent, Belgium, 9000

UZ Leuven

Leuven, Belgium, 3000

Centre Hospitalier Universitaire Université Cathol

Namur, Belgium, 5000

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

Goiânia, Brazil, 74605-070

ONCOSITE - Centro de Pesquisa Clinica em Oncologia

Ijuí, Brazil, 98700-000

Catarina Pesquisa Clínica

Itajaí, Brazil, 88301-220

Hospital Moinhos de Vento

Porto Alegre, Brazil, 90035-00

Hospital de Clinicas de Porto Alegre - HCPA

Porto Alegre, Brazil, 90035-903

Hospital Sao Lucas da PUCRS

Porto Alegre, Brazil, 90610001

Instituto Nacional de Câncer - INCA - HCIII

Rio de Janeiro, Brazil

Núcleo de Oncologia da Bahia

Salvador, Brazil, 40170170

CEPHO - Centro de Estudos e PesquisaS de Hematologia e Oncologia

Santo André, Brazil, 09060-650

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

São Paulo, Brazil, 01323-001

Clinica de Pesquisas e Centro de Estudos em Oncolo

São Paulo, Brazil, 1317000

Fundação Pio XII - Hospital de Amor de Barretos

São Paulo, Brazil, 14784400

Hospital Amaral Carvalho

São Paulo, Brazil, 17210080

Nucleo de Pesquisa Clinica da Rede Sao Camilo

São Paulo, Brazil, 4014002

Cross Cancer Institute

Edmonton, Canada, T6G 1Z2

QEII Health Sciences Centre

Halifax, Canada, B3H 1V7

Grand River Regional Cancer Centre at Grand River Hospital

Kitchener, Canada, N2G 1G3

London Health Sciences Centre

London, Canada, N6A 5W9

Jewish General Hospital Department of Medical Oncology

Montreal, Canada, H3T 1E2

McGill University Health Centre

Montreal, Canada, H4A 3J1

Ottawa Hospital - General Campus

Ottawa, Canada, K1H 8L6

Sunnybrook Research Institute

Toronto, Canada, M4N 3M5

Mount Sinai Hospital

Toronto, Canada, M5G 1X5

Oncovida - Santiago

Providencia, Chile, 7510035

Clínica Alemana

Santiago, Chile, 7630000

Clínica IRAM

Santiago, Chile

Centro de Oncología de Precisión

Santiago Region, Chile, 8330032

James Lind Centro de Investigacion del Cancer

Temuco, Chile

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China, 100021

Peking University People's Hospital

Beijing, China, 100044

Beijing Cancer Hospital

Beijing, China, 100142

The First Medical Center of Chinese PLA General Hospital

Beijing, China, 100853

The Second Xiangya Hospital of Central South University

Changsha, China, 410011

Sichuan Cancer Hospital

Chengdu, China, 610041

West China Hospital, Sichuan University

Chengdu, China, 610041

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China, 400016

Chongqing University Cancer Hospital

Chongqing, China, 404100

Deyang People's Hospital

Deyang, China, 618000

Sun Yat-Sen University Cancer Center

Guangzhou, China, 510000

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, China, 31006

Harbin Medical University Cancer Hospital

Harbin, China, 150081

Anhui Provincial Cancer Hospital

Hefei, China, 230031

The Second Hospital of Anhui Medical University

Hefei, China, 230601

The Second Hospital of Jilin University

Jilin Sheng, China, 130041

The Second Hospital of Shandong University

Jinan, China, 250033

Shandong Cancer Hospital

Jinan, China, 250117

Nanchang People's hospital

Nanchang, China, 330200

The First Affiliated Hospital of Guangxi Medical University

Nanning, China, 530021

Tianjin Medical University Cancer Institute& Hospital

Tianjin, China, 453000

Weihai Municipal Hospital

Weihai, China, 264299

Hubei Cancer Hospital

Wuhan, China, 430000

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

Wuhan, China, 430022

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

Wuhan, China, 430030

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China, 710061

The Second Affiliated Hospital of Zhejiang University School of Medicine

Zhejiang, China, 310009

The First Affiliated Hospital of Wenzhou Medical University

Zhejiang, China, 325000

Masarykuv onkologicky ustav, klinika komplexni onkologickie pece

Brno, Czechia, 65653

Fakultni nemocnice Hradec Kravlove, Klinika onkologie a radioterapie

Hradec Králové, Czechia, 500 05

Fakultní Thomayerova nemocnice

Hradec Králové, Czechia, 50005

Fakultni nemocnice Olomouc, Onkologicka klinika

Olomouc, Czechia, 77520

Fakultni nemocnice Karlovske Vinohrady, Radioterapeuticka a onkologicka klinika

Prague, Czechia, 100 34

Vseobecna Fakultni Nemocnice v Praze

Prague, Czechia, 12808

Sainte Catherine Institut du Cancer Avignon Provence

Avignon, France, 84918

Centre Hospitalier Régional et Universitaire de Be

Besançon, France, 25030

Hôpital Morvan, Institut de cancérologie

Brest, France, 29200

Centre francois Baclesse

Caen, France, 14000

Centre Jean Perrin

Clermont-Ferrand, France, 63011

Centre de Cancérologie du Grand Montpellier

Montpellier, France, 34070

Hôpital Privé du Confluent

Nantes, France, 44202

Hospices Civils de Lyon Hôpital Lyon Sud

Pierre-Bénite, France, 69310

Centre Armoricain de Radiothérapie, dImagerie Méd

Plérin, France, 22190

Centre Eugène Marquis

Rennes, France, 35042

Institut Claudius Regaud - IUCT-O

Toulouse, France

Institut Gustave Roussy

Villejuif, France, 94800

Helios Klinikum Berlin-Buch

Berlin, Germany, 13125

Gynakologisches Zentrum Bonn, Schwerpunkt Gyn. Onkologie,

Bonn, Germany, 53111

Klinik Frauenheilkunde, Uniklinik ClO, Studienzentrale

Cologne, Germany, 50937

Kliniken Essen-Mitte - Evangelische Huyssens-Stift Breast Unit

Essen, Germany, 45136

Universitatsklinikum Hamburg-Eppendorf

Hamburg, Germany, 20246

Nationales Centrum für Tumorerkrankungen - Heidelb

Heidelberg, Germany, 69120

Universitätsklinikum Schleswig-Holstein Institut fur Klinische Chermie

Lübeck, Germany, 23538

Universitatsklinikum Mannheim GmBH, Frauenklinik

Mannheim, Germany, 68167

Universitätsklinikum Tübingen

Tübingen, Germany, 72076

Queen Mary Hospital

Hong Kong, Hong Kong

Tuen Mun Hospital

Hong Kong, Hong Kong

Queen Mary Hospital

Pok Fu Lam, Hong Kong, 0

Uzsoki Utcai Kornaz, Onkoradiologiai Osztaly

Budapest, Hungary, 1145

Debreceni Egyetem Klinikai Központ

Debrecen, Hungary, 4032

Petz Aladar Egyetemi Oktaté Kérhaz - Osztaly

Győr, Hungary, 9024

Rambam Health Care Campus

Haifa, Israel, 3109601

Hadassah - Hebrew University Medical Center

Jerusalem, Israel

Meir Medical Center

Kfar Saba, Israel, 4428164

Rabin Medical Center

Petah Tikva, Israel, 4941492

Kaplan Medical Center

Rehovot, Israel, 7661041

Sheba Medical Center Hospital - Tel Hashomer

Tel Aviv, Israel, 52621

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel, 64239

IRCCS Istituto Tumori "G.Paolo II"

Bari, Italy, 70124

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, Italy, 25123

IRCSS Ospedale Policlinico San Martino

Genova GE, Italy, 16132

S.C. Oncologia medica, ASST di Lecco

Lecco, Italy, 23900

Presidio Ospedaliero di Lucca

Lucca, Italy, 55100

Ospedale Generale Provinciale - Macerata

Macerata, Italy, 62100

Istituto Europeo di Oncologia

Milan, Italy, 20141

Fondazione IRCCS - Istituto Nazionale dei Tumori

Milan, Italy, 20133

Azienda Socio Sanitaria Territoriale

Monza, Italy, 20090

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

Napoli, Italy, 80131

Azienda Ospedaliero-Universitaria Maggiore della C

Novara, Italy, 28100

Istituto Oncologico Veneto - IRCCS

Padua, Italy, 35128

AOU Policlinico Umberto I

Roma, Italy, 00161

Fondazione Policlinico Universitario Agostino Geme

Rome, Italy, 00168

Aichi Cancer Center Hospital

Aichi, Japan, 464-8681

Juntendo University Hospital

Bunkyō City, Japan, 113-8431

Chiba Cancer Center

Chūōku, Japan, 260-8717

Shikoku Cancer Center

Ehime, Japan, 791-0280

Hakuaikai Sagara Hospital

Kagoshima, Japan, 892-0833

National Cancer Center Hospital East

Kashiwa, Japan, 277-8577

Cancer Institute Hospital of JFCR

Kōtoku, Japan, 135-8550

Kumamoto University Hospital

Kumamoto, Japan, 860-8556

Kure Medical Center And Chugoku Cancer Center

Kure, Japan, 737-0023

National Hospital Organization Kyushu Cancer Center

Minamiku, Japan, 811-1395

Nagoya University Hospital

Nagoya, Japan, 466-8560

Hiroshima City Hiroshima Citizens Hospital

Nakaku, Japan, 730-8518

Okayama University Hospital

Okayama, Japan, 700-8558

Kyoto University Hospital

Sakyo-ku, Japan, 606-8507

Hokkaido Cancer Center

Sapporo, Japan, 003-0804

Shizuoka Cancer Center

Shizuoka, Japan, 411-8777

Shizuoka General Hospital

Shizuoka, Japan, 420-8527

Osaka University Hospital

Suita, Japan, 565-0871

Showa University Hospital

Tokyo, Japan, 142-8555

Kanagawa Cancer Center

Yokohama, Japan, 241-8515

Hospital Pulau Pinang

George Town, Malaysia, 10450

Hospital Sultan Ismail

Johor Bahru, Malaysia, 81100

Hospital Kuala Lumpur

Kuala Lumpur, Malaysia, 47500

Pantai Hospital Kuala Lumpur

Kuala Lumpur, Malaysia, 59100

University Malaya Medical Centre (UMMC)

Kuala Lumpur, Malaysia, 59100

Institut Kanser Negara

Putrajaya, Malaysia, 62250

Sarawak General Hospital

Sarawak, Malaysia, 93586

Icaro Investigaciones en Medicina

Chihuahua City, Mexico, 31000

Sinacor - Centro para el Desarrollo de la Medicina

Culiacán, Mexico, 80230

Panamerican Clinical Research Mexico - Guadalajara

Guadalajara, Mexico, 44670

Cryptex Investigación Clínica

Mexico City, Mexico, 06100

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

Mérida, Mexico, 97070

Fucam A.C.

México, Mexico, 4980

Avix Investigacion Clinica S.C.

Monterrey, Mexico, 64710

Oncológico Potosino

San Luis Potosí City, Mexico, 78209

FAICIC Clínical Research

Veracruz, Mexico, 91900

iBiomed - Investigacion Biomedica para el Desarrol

Zapopan, Mexico, 45070

Amphia Ziekenhuis - Breda Langendijk

Breda, Netherlands, 4818 CK

Universitair Medisch Centrum Groningen

Groningen, Netherlands, 9700 RB

Medisch Centrum Leeuwarden

Leeuwarden, Netherlands, 8934 AD

Maastricht Universitair Medisch Centrum

Maastricht, Netherlands, 6229HX

Erasmus Medisch Centrum

Rotterdam, Netherlands

Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

Gdansk, Poland, 80-952

Narodowy Instytut Onkologii im. Marii Sklodowskiej

Gliwice, Poland, 44-102

SP ZOZ Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego

Opole, Poland, 45-061

Mazowiecki Szpital Wojewódzki im. w. Jana Pawa II

Siedlce, Poland, 08-110

Narodowy Instytut Onkologii im.Marii Marii Sklodowskiej

Warsaw, Poland, 02-781

Spitalul Clinic Filantropia

Bucharest, Romania, 11171

SC Medisprof SRL

Cluj-Napoca, Romania, 400058

Institutal Oncologic, Prof. Dr Ion Chiricuta

Cluj-Napoca, Romania, 400150

Centrul De Oncologie Sf Nectarie

Craiova, Romania, 200642

Onkologicky Ustav Sv. Alzbety

Bratislava, Slovakia, 81250

Národný onkologický ústav

Bratislava, Slovakia, 83310

Nemocnica Partizánske

Partizánske, Slovakia, 95801

Hopelands Cancer Centre

Hilton, South Africa, 3245

Wits Clinical Research

Johannesburg, South Africa, 2192

The Medical Oncology Centre of Rosebank

Johannesburg, South Africa, 2196

National Cancer Center

Goyang-si Gyeonggi-do, South Korea, 10408

Seoul National University Bundang Hospital

Seongnam-si, South Korea, 13620

Severance Hospital, Yonsei University Health System

Seoul, South Korea, 03722

Asan Medical Center

Seoul, South Korea, 05505

Samsung Medical Center

Seoul, South Korea, 06351

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

Seoul, South Korea, 06591

Korea University Anam Hospital

Seoul, South Korea, 2841

Seoul National University Hospital

Seoul, South Korea, 3080

Hospital Teresa Herrera - Materno Infantil

A Coruña, Spain, 15006

Hospital Universitari Dexeus

Barcelona, Spain, 08028

Hospital Universitari Vall d'Hebrón

Barcelona, Spain, 8035

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain, 8041

Hospital Universitario de Basurto

Bilbao, Spain, 48013

Hospital Universitari Arnau de Vilanova

Lleida, Spain, 25198

Hospital General Universitario Gregorio Maranon

Madrid, Spain, 28007

MD Anderson Cancer Center Madrid

Madrid, Spain, 28033

Hospital Universitario Fundación Jiménez Díaz

Madrid, Spain, 28040

Hospital General Universitario Morales Meseguer

Murcia, Spain, 30008

Hospital Unviersitario Virgen del Rocio

Seville, Spain, 41013

Hospital Universitario Virgen Macarena

Seville, Spain, 41071

Hospital Clínico Universitario de Valencia

Valencia, Spain, 46010

Kantonsspital St.Gallen

Sankt Gallen, Switzerland, 9007

Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Hualien City, Taiwan, 970

Taichung Veterans General Hospital

Taichung, Taiwan, 40705

National Cheng Kung University Hospital

Tainan City, Taiwan, 704

Chi Mei Hospital, Lioying

Tainan City, Taiwan, 73657

National Taiwan University Hospital

Taipei, Taiwan, 10048

MacKay Medical Foundation The Presbyterian Church in Taiwan MacKay Memorial Hospital

Taipei, Taiwan, 104217

Chang Gung Memorial Hospital, Linkou

Taoyuan, Taiwan, 33305

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

Adana, Turkey (Türkiye), 1120

Memorial Ankara Hastanesi

Ankara, Turkey (Türkiye), 06520

Ankara Il Saglik Mudurlugu SBU Gulhane Egitim Ve A

Ankara, Turkey (Türkiye), 6010

Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

Ankara, Turkey (Türkiye), 6200

Hacettepe Üniversitesi Hastanesi

Ankara, Turkey (Türkiye)

Trakya Universitesi Tip Fakultesi Hastanesi

Edirne, Turkey (Türkiye), 22030

Istanbul Il Saglik Mudurlugu Goztepe Prof. Dr. Sul

Istanbul, Turkey (Türkiye), 34000

Medipol Mega Universite Hastanesi

Istanbul, Turkey (Türkiye), 34214

Ege Universitesi Hastanesi

Izmir, Turkey (Türkiye), 35100

Medicana International Izmir Hastanesi

Izmir, Turkey (Türkiye), 35575

Acibadem Maslak Hastanesi

Sarıyer, Turkey (Türkiye)

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom, LS9 7TF

Barts Health NHS Trust

London, United Kingdom, EC1M 6BQ

University College London Hospitals NHS Foundation

London, United Kingdom, WC1E 6BT

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)

OVERVIEW

PROTOCOL SUMMARY

Participation Requirements

Eligibility Information

Inclusion Criteria

Exclusion Criteria

Locations

Locations (363)

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

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

Arizona Oncology Associates, PC-Hope

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

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

University of California San Diego Moores Cancer

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

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

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

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

University of California Los Angeles - Jonsson Comprehensive Cancer Center

Torrance Memorial Physician Network - Cancer Care

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

Rocky Mountain Cancer Centers,1700 South Potomac Street

Rocky Mountain Cancer Centers

Rocky Mountain Cancer Centers,2312 N. Nevada Avenue

Rocky Mountain Cancer Centers,6031 E. Woodman Rd.

Rocky Mountain Cancer Centers,4700 E. Hale Parkway

Rocky Mountain Cancer Centers,11750 West 2nd Place

Rocky Mountain Cancer Centers,22 West Dry Creek Circle

Rocky Mountain Cancer Centers,10107 Ridge Gate Parkway

Rocky Mountain Cancer Centers,2030 Mountain View Ave Ste 210

Rocky Mountain Cancer Centers,3676 Parker Blvd

Rocky Mountain Cancer Centers,525 W. 15th Street

Rocky Mountain Cancer Centers,8820 Huron Street

AdventHealth Medical Group

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

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

Florida Cancer Specialists,3630 Manatee Avenue West

Florida Cancer Specialists,5985 Silver Falls Run

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

Florida Cancer Specialists,1030 Commerce Creek Blvd

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

Florida Cancer Specialists

Florida Cancer Specialists,8981 Colonial Center Drive

Florida Cancer Specialists,8260 Gladiolus Dr

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

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

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

Florida Cancer Specialists,1100 Goodlette Road

Florida Cancer Specialists,681 4th Avenue North

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

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

AdventHealth Medical Group,2501 North Orange Ave

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

Florida Cancer Specialists,22395 Edgewater Drive

Florida Cancer Specialists,600 North Cattlemen Road

Florida Cancer Specialists,1970 Golf Street

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

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

Florida Cancer Specialists - North Region Research Office

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

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

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

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

Florida Cancer Specialists,901 South Tamiami Trail

Florida Cancer Specialists,836 Sunset Lake Blvd

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

Northside Hospital,125 King Avenue

Northside Hospital,5670 Peachtree Dunwoody Rd.

Northside Hospital

Northside Hospital,308 Deep South Farm Rd, Suite 200

Northside Hospital,228 Riverstone Dr.

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

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

Northside Hospital,1505 Northside Blvd, Suite 4600

Northside Hospital,3855 Pleasant Hill Rd., Suite 480

Northside Hospital,308 Coliseum Dr.

Northwest Georgia Oncology Northwest Georgia Oncology Centers, PCCenters, PC

Robert H. Lurie Comprehensive Cancer Center of Northwestern University