AzTrials
AzTrials

Triple Negative Breast CancerPhase 3ASCENT-04NCT05382286

Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer

A Phase 3 study testing Sacituzumab Govitecan-hziy, Pembrolizumab and Paclitaxel in people with Triple Negative Breast Cancer and PD-L1 Positive, run by Gilead Sciences at 504 sites in 28 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) and pembrolizumab versus treatment of physician's choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast… 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 Positive
What is being tested?
Sacituzumab Govitecan-hziy, Pembrolizumab and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
443 participants
Where
504 sitesin 28 countries
Study dates
25 Jul 2022to Feb 2027
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 with locally advanced, inoperable, or metastatic triple-negative breast cancer (TNBC) who have not received previous systemic therapy for advanced disease and whose tumors are programmed cell death ligand 1 (PD-L1) positive at screening.
  • Individuals must have completed treatment for Stage I to III breast cancer, if indicated, and ≥ 6 months must have elapsed between completion of treatment with curative intent and first documented local or distant disease recurrence.
  • Individuals presenting with de novo metastatic TNBC are eligible for this study.
  • TNBC status and tumor PD-L1 combined positive score (CPS) will be confirmed centrally on a recent or archival tumor specimen.
  • Individuals must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria as evaluated locally.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
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  • Demonstrates adequate organ function
  • Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
  • Individuals with 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 prior therapy with an agent directed to another stimulatory or coinhibitory T-cell receptor.
  • Individuals may not have received systemic anticancer treatment (with the exception of endocrine therapy) within the previous 6 months or radiation therapy within 2 weeks prior to enrollment.
  • Individuals 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.
  • Have previously received topoisomerase 1 inhibitors or antibody drug conjugates containing a topoisomerase inhibitor.
  • Have an active second malignancy.
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  • Have active serious infection requiring antibiotics.
  • Individuals positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
  • Have active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
  • Has an active autoimmune disease that has required systemic treatment in the past 2 years.
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

504 sites in 28 countries.

504 sites in 28 countries

United States247 sites

  • Advent Health Medical Group

    Altamonte Springs, Florida, 32701

  • SCRI - Florida Cancer Specialists - North Region R,750 Orienta Ave

    Altamonte Springs, Florida, 32701

  • Alaska Oncology and Hematology

    Anchorage, Alaska, 99508

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • The Center for Cancer and Blood Disorders - Magnolia,515 W. Mayfield Rd.

    Arlington, Texas, 76104

  • Northside Hospital,125 King Avenue

    Athens, Georgia, 30606

  • Piedmont Cancer Institute - Atlanta,1267 Hwy 54W

    Atlanta, Georgia, 30214

  • Winship Cancer Institute of Emory University,550 Peachtree St NE

    Atlanta, Georgia, 30308

  • Piedmont Cancer Institute - Atlanta

    Atlanta, Georgia, 30318

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

  • Northside Hospital,5670 Peachtree Dunwoody Rd.

    Atlanta, Georgia, 30342

  • Northside Hospital

    Atlanta, Georgia, 30342

  • Winship Cancer Institute of Emory University,5665 Peachtree Dunwoody Road

    Atlanta, Georgia, 30342

  • Rocky Mountain Cancer Centers,1700 South Potomac Street

    Aurora, Colorado, 80012

  • Texas Oncology-Austin,901 West 38th Street

    Austin, Texas, 78705

  • Texas Oncology-Austin

    Austin, Texas, 78731

  • Texas Oncology-Austin,4101 James Casey, Suite 100

    Austin, Texas, 78745

  • University of Miami - Sylvester Comprehensive Cancer Center,2801 NE 213th St

    Aventura, Florida, 33180

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

    Babylon, New York, 11702

  • Cancer Institute Ascension Saint Agnes

    Baltimore, Maryland, 21229

  • Hematology Oncology Clinic - Baton Rouge

    Baton Rouge, Louisiana, 70809

  • Summit Medical Group,1 Diamond Hill Road

    Berkeley Heights, New Jersey, 07922

  • Magee-Womens Hospital of UPMC,200 Oxford Drive

    Bethel Park, Pennsylvania, 15102

  • 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

  • Massachusetts General Hospital

    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

  • SCRI - Florida Cancer Specialists - North Region R,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

  • The Center for Cancer and Blood Disorders - Magnolia,11805 South Freeway

    Burleson, Texas, 76028

  • Northside Hospital,228 Riverstone Dr.

    Canton, Georgia, 30114

  • Florida Cancer Specialists,1030 Commerce Creek Blvd

    Cape Coral, Florida, 33909

  • Virginia Oncology Associates,744 N. Battlefield Blvd

    Chesapeake, Virginia, 23320

  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University

    Chicago, Illinois, 60611

  • University of Illinois Hospital and Health Sciences System (Outpatient Cancer Center)

    Chicago, Illinois, 60612

  • Orchard Healthcare Research Inc,2845 North Sheridan Road, 1st Floor

    Chicago, Illinois, 60657

  • SCRI - Florida Cancer Specialists - North Region R,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

  • The Ohio State University Wexner Medical Center Clinical Laboratories

    Columbus, Ohio, 43212

  • Zangmeister Cancer Center

    Columbus, Ohio, 43219

  • University of Miami - Sylvester Comprehensive Cancer Center,5555 Ponce De Leon Blvd

    Coral Gables, Florida, 33146

  • University of California Irvine Health Chao Family,1640 Newport Blvd

    Costa Mesa, California, 92627

  • Magee-Womens Hospital of UPMC,3 St. Francis Way

    Cranberry Township, Pennsylvania, 16066

  • Northside Hospital,1505 Northside Blvd, Suite 4600

    Cumming, Georgia, 30041

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • Massachusetts General Hospital,102 Endicott Street

    Danvers, Massachusetts, 01923

  • SCRI - Florida Cancer Specialists - West Palm Beach,224 Memorial Medical Parkway, Suite 300

    Daytona Beach, Florida, 32117

  • University of Miami - Sylvester Comprehensive Cancer Center,1192 East Newport Center Drive

    Deerfield Beach, Florida, 33442

  • 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

  • Texas Oncology-Denison

    Denison, Texas, 75020

  • Rocky Mountain Cancer Centers,4700 E. Hale Parkway

    Denver, Colorado, 80220

  • Tennessee Oncology, PLLC,103 Natchez Park Drive

    Dickson, Tennessee, 37055

  • City of Hope

    Duarte, California, 91010

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

    Duluth, Georgia, 30096

  • Regional Cancer Care Associates - East Brunswick

    East Brunswick, New Jersey, 08816

  • 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

  • Orchard Healthcare Research Inc,800 Austin Street, Suite 360, East Tower

    Evanston, Illinois, 60202

  • Huntsman Cancer Institute, University of Utah,165 North University Avenue

    Farmington, Utah, 84025

  • Summit Medical Group

    Florham Park, New Jersey, 07932

  • 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

  • Regulatory Management Only: TRIO-US Central Administration

    Fort Wayne, Indiana, 46845

  • The Center for Cancer and Blood Disorders - Magnolia

    Fort Worth, Texas, 76104

  • Tennessee Oncology, PLLC,4488 Carothers Parkway

    Franklin, Tennessee, 37067

  • SCRI - Florida Cancer Specialists - North Region R,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

  • Nebraska Cancer Specialists,2730 W. Faidley Ave

    Grand Island, Nebraska, 68803

  • Magee-Womens Hospital of UPMC,200 Village Drive

    Greensburg, Pennsylvania, 15601

  • Ascension St. John Hospital

    Grosse Pointe Woods, Michigan, 48236

  • John Theurer Cancer Center

    Hackensack, New Jersey, 07601

  • Rutgers Cancer Institute of New Jersey,2575 Klockner Road

    Hamilton, New Jersey, 08690

  • Comprehensive Cancer Centers of Nevada - Central V,10001 S. Eastern Avenue, Suite 108

    Henderson, Nevada, 89052

  • Comprehensive Cancer Centers of Nevada - Central V,2460 W. Horizon Ridge Parkway

    Henderson, Nevada, 89052

  • Comprehensive Cancer Centers of Nevada - Central V,1501 Wigwam Parkway, Suite 1300

    Henderson, Nevada, 89074

  • Tennessee Oncology, PLLC,353 New Shackle Island Road

    Hendersonville, Tennessee, 37075

  • Tennessee Oncology, PLLC,5653 First Blvd.

    Hermitage, Tennessee, 37076

  • University of Miami - Sylvester Comprehensive Cancer Center,3850 Hollywood Blvd

    Hollywood, Florida, 33021

  • Genesis Cancer and Blood Institute

    Hot Springs, Arkansas, 71913

  • Genesis Cancer and Blood Institute,1456 Higdon Ferry Road Suite B.

    Hot Springs, Arkansas, 71914

  • Oncology Consultants,1631 North Loop West

    Houston, Texas, 77008

  • Oncology Consultants,925 Gessner

    Houston, Texas, 77024

  • Oncology Consultants

    Houston, Texas, 77030

  • University of Texas MD Anderson Cancer Center,1155 Pressler St

    Houston, Texas, 77030

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Rutgers Cancer Institute of New Jersey,414 Grand Street

    Jersey City, New Jersey, 07302

  • Saint Bernards Medical Center

    Jonesboro, Arkansas, 72401

  • The University of Kansas Cancer Center,2000 Olathe Blvd

    Kansas City, Kansas, 66160

  • The University of Kansas Cancer Center,2750 Clay Edwards Drive

    Kansas City, Missouri, 64116

  • The University of Kansas Cancer Center,8700 North Green Hills Road

    Kansas City, Missouri, 64154

  • 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

  • Rutgers Cancer Institute of New Jersey,600 River Avenue

    Lakewood, New Jersey, 08701

  • SCRI - Florida Cancer Specialists - North Region R,100 Highland Avenue

    Largo, Florida, 33770

  • Comprehensive Cancer Centers of Nevada - Central V,653 North Town Center Drive, Suite 402

    Las Vegas, Nevada, 89144

  • Comprehensive Cancer Centers of Nevada - Central V,9280 W. Sunset Road Suite 100

    Las Vegas, Nevada, 89148

  • Comprehensive Cancer Centers of Nevada - Central V,7445 Peak Drive

    Las Vegas, Nevada, 89169

  • Comprehensive Cancer Centers of Nevada - Central V

    Las Vegas, Nevada, 89169

  • Tennessee Oncology, PLLC,103 Physicians Way

    Lebanon, Tennessee, 37090

  • SCRI - Florida Cancer Specialists - North Region R,521 North Lecanto Highway

    Lecanto, Florida, 34461

  • The University of Kansas Cancer Center,4881 N.E. Goodview Circle

    Lee's Summit, Missouri, 64064

  • Rocky Mountain Cancer Centers,22 West Dry Creek Circle

    Littleton, Colorado, 80120

  • Rutgers Cancer Institute of New Jersey,94 Old Short Hills Road

    Livingston, New Jersey, 07039

  • Rocky Mountain Cancer Centers,10107 Ridge Gate Parkway

    Lone Tree, Colorado, 80124

  • Rutgers Cancer Institute of New Jersey,300 Second Ave

    Long Branch, New Jersey, 07740

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

    Longmont, Colorado, 80124

  • Cancer and Blood Specialty Clinic

    Los Alamitos, California, 90720

  • 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

  • Virginia Cancer Institute,7501 Right Flank Road

    Mechanicsville, Virginia, 23116

  • University of Miami - Sylvester Comprehensive Cancer Center,1400 NW 12th Ave

    Miami, Florida, 33136

  • University of Miami - Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • University of Miami - Sylvester Comprehensive Cancer Center,8932 S.W. 97 Ave

    Miami, Florida, 33176

  • Perlmutter Cancer Center - Manhattan - 34th Street,259 First Street

    Mineola, New York, 11501

  • Regional Cancer Care Associates - East Brunswick,9 Centre Drive

    Monroe, New Jersey, 08831

  • Magee-Womens Hospital of UPMC,400 Oxford Drive

    Monroeville, Pennsylvania, 15146

  • Tennessee Oncology, PLLC,1840 Medical Center Parkway

    Murfreesboro, Tennessee, 37129

  • Florida Cancer Specialists,1100 Goodlette Road

    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

  • Regional Cancer Care Associates - East Brunswick,34-36 Progress Street

    New Brunswick, New Jersey, 08820

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

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

    New Hyde Park, New York, 11042

  • Perlmutter Cancer Center - Manhattan - 34th Street

    New York, New York, 10016

  • NYP/Columbia Univeresity Medical Center/Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032

  • Rutgers Cancer Institute of New Jersey,150 Bergen St.

    Newark, New Jersey, 07103

  • Rutgers Cancer Institute of New Jersey,201 Lyons Avenue

    Newark, New Jersey, 07112

  • Piedmont Cancer Institute - Atlanta,775 Poplar Road

    Newnan, Georgia, 30265

  • City of Hope,1601 Avocado Ave

    Newport, California, 92660

  • Virginia Oncology Associates,1051 Loftis Blvd Suite 100

    Newport News, Virginia, 23606

  • Massachusetts General Hospital,2014 Washington St

    Newton, Massachusetts, 02462

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Eastern Connecticut Hematology and Oncology Associates

    Norwich, Connecticut, 06360

  • SCRI - Florida Cancer Specialists - North Region R,4945 SW 49th Place

    Ocala, Florida, 34474

  • Nebraska Cancer Specialists,8303 Dodge Street

    Omaha, Nebraska, 68114

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

  • University of California Irvine Health Chao Family

    Orange, California, 92868

  • SCRI - Florida Cancer Specialists - North Region R,2824 Enterprise Rd

    Orange City, Florida, 32763

  • Advent Health Medical Group,2501 North Orange Ave

    Orlando, Florida, 32804

  • SCRI - Florida Cancer Specialists - North Region R,70 W. Gore Street

    Orlando, Florida, 32806

  • The University of Kansas Cancer Center,12200 W. 110th Street

    Overland Park, Kansas, 66210

  • The University of Kansas Cancer Center,10710 Nall Avenue

    Overland Park, Kansas, 66211

  • The University of Kansas Cancer Center,10730 Nall Avenue

    Overland Park, Kansas, 66211

  • Nebraska Cancer Specialists,611 Fenwick Dr

    Papillion, Nebraska, 68046

  • Saint Bernards Medical Center,4000 Linwood Drive

    Paragould, Arkansas, 72450

  • City of Hope,209 Fair Oaks Ave

    Pasadena, California, 91030

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

    Patchogue, New York, 11772

  • Virginia Cancer Institute,210 Medical Park Boulevard

    Petersburg, Virginia, 23805

  • University of Pennsylvania Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Magee-Womens Hospital of UPMC,300 Halket Street

    Pittsburgh, Pennsylvania, 15213

  • Magee-Womens Hospital of UPMC

    Pittsburgh, Pennsylvania, 15213

  • Magee-Womens Hospital of UPMC,5115 Centre Avenue

    Pittsburgh, Pennsylvania, 15232

  • Magee-Womens Hospital of UPMC,9100 Babcock Boulevard

    Pittsburgh, Pennsylvania, 15237

  • University of Miami - Sylvester Comprehensive Cancer Center,8100 SW 10 Street

    Plantation, Florida, 33324

  • 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

  • Northwest Cancer Specialists, PC,5050 NE Hoyt St.

    Portland, Oregon, 97213

  • Northwest Cancer Specialists, PC,265 N. Broadway

    Portland, Oregon, 97227

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Rhode Island Hospital,164 Summit Ave, Fain 275A

    Providence, Rhode Island, 02906

  • Rocky Mountain Cancer Centers,3676 Parker Blvd

    Pueblo, Colorado, 81008

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

    Pueblo, Colorado, 81008

  • Virginia Cancer Institute,1401 Johnston-Willis Drive

    Richmond, Virginia, 23235

  • Virginia Cancer Institute

    Richmond, Virginia, 23298

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

    Riverhead, New York, 11901

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Huntsman Cancer Institute, University of Utah,1280 E. Stringham Avenue

    Salt Lake City, Utah, 84106

  • Huntsman Cancer Institute, University of Utah

    Salt Lake City, Utah, 84112

  • Mays Cancer Center

    San Antonio, Texas, 78229

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

    San Luis Obispo, California, 93401

  • Sansum Clinic

    Santa Barbara, California, 93105

  • 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

  • St. Jude Hospital Yorba dba St. Joseph Heritage Healthcare

    Santa Rosa, California, 95403

  • Florida Cancer Specialists,600 North Cattlemen Road

    Sarasota, Florida, 34232

  • Florida Cancer Specialists,1970 Golf Street

    Sarasota, Florida, 34236

  • Magee-Womens Hospital of UPMC,100 Fairfield Dr

    Seneca, Pennsylvania, 16346

  • Tennessee Oncology, PLLC,120 Frank Martin Road

    Shelbyville, Tennessee, 37160

  • Orchard Healthcare Research Inc

    Skokie, Illinois, 60077

  • Tennessee Oncology, PLLC,300 Stonecrest Blvd

    Smyrna, Tennessee, 37167

  • Sansum Clinic,2040 Viborg Road

    Solvang, California, 93463

  • Regional Cancer Care Associates - East Brunswick,75 Veronica Avenue

    Somerset, New Jersey, 08873

  • Rutgers Cancer Institute of New Jersey,110 Rehill Ave

    Somerville, New Jersey, 08876

  • Huntsman Cancer Institute, University of Utah,5126 West Daybreak Parkway

    South Jordan, Utah, 84009

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

    Southaven, Mississippi, 38671

  • Ascension Providence Hospital Southfield Cancer Center

    Southfield, Michigan, 48075

  • SCRI - Florida Cancer Specialists - North Region R,7154 Medical Center Drive

    Spring Hill, Florida, 34608

  • SCRI - Florida Cancer Specialists - North Region R,1201 Fifth Avenue North

    St. Petersburg, Florida, 33705

  • SCRI - Florida Cancer Specialists - North Region R

    St. Petersburg, Florida, 33705

  • Piedmont Cancer Institute - Atlanta,1240 Eagles Landing Pkwy

    Stockbridge, Georgia, 30281

  • SCRI - Florida Cancer Specialists - West Palm Beach,301 SE Ocean Blvd, Suite 102

    Stuart, Florida, 34994

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

    Tampa, Florida, 33607

  • SCRI - Florida Cancer Specialists - North Region R,4100 Waterman Way

    Tavares, Florida, 32778

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

    The Bronx, New York, 10028

  • Montefiore Medical Center - Montefiore Medical Park

    The Bronx, New York, 10467

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

    The Bronx, New York, 10469

  • SCRI - Florida Cancer Specialists - North Region R,1400 US Highway 441 N

    The Villages, Florida, 32159

  • Rocky Mountain Cancer Centers,8820 Huron Street

    Thornton, Colorado, 80260

  • Northwest Cancer Specialists, PC

    Tigard, Oregon, 97223

  • Rutgers Cancer Institute of New Jersey,99 Highway 37 West

    Toms River, New Jersey, 08755

  • City of Hope,5215 Torrance Blvd

    Torrance, California, 90503

  • Torrance Memorial Physician Network - Cancer Care

    Torrance, California, 90505

  • SCRI - Florida Cancer Specialists - North Region R,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

  • City of Hope,1100 San Bernardino Rd

    Upland, California, 91786

  • Northwest Cancer Specialists, PC,210 SE 136th Avenue

    Vancouver, Washington, 98684

  • Florida Cancer Specialists,836 Sunset Lake Blvd

    Venice, Florida, 34292

  • SCRI - Florida Cancer Specialists - West Palm Beach,3730 7th Terrace, Suite 101

    Vero Beach, Florida, 32960

  • 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

  • Magee-Womens Hospital of UPMC,470 Johnson Road

    Washington, Pennsylvania, 15301

  • The Center for Cancer and Blood Disorders - Magnolia,920 Santa Fe Drive

    Weatherford, Texas, 76086

  • SCRI - Florida Cancer Specialists - West Palm Beach,1037 S. State Road 7, Bldg B, Suite 303

    Wellington, Florida, 33414

  • Rutgers Cancer Institute of New Jersey,100 State Route 36

    West Long Branch, New Jersey, 07764

  • SCRI - Florida Cancer Specialists - West Palm Beach

    West Palm Beach, Florida, 33401

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

    Westlake Village, California, 91361

  • The University of Kansas Cancer Center

    Westwood, Kansas, 66205

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

    Winfield, Illinois, 60190

  • SCRI - Florida Cancer Specialists - North Region R,460 N Orlando Ave

    Winter Park, Florida, 32789

  • Magee-Womens Hospital of UPMC,1703 Innovation Drive

    York, Pennsylvania, 17408

  • Hematology Oncology Clinic - Baton Rouge,1673 E Mount Please Drive

    Zachary, Louisiana, 70791

Other trials in United States

Japan28 sites

  • Aichi Cancer Center Hospital

    Aichi, 464-8681

  • Tohoku University Hospital

    Aoba-ku, 980-8574

  • Juntendo University Hospital

    Bunkyō City, 113-8431

  • Chiba Cancer Center

    Chūōku, 260-8717

  • Osaka Prefectural Hospital Organization Osaka International Cancer Institute

    Chūōku, 541-8567

  • NHO Shikoku Cancer Center

    Ehime, 791-0280

  • Fukushima Medical University Hospital

    Fukushima

  • Saitama Cancer Center

    Inamachi, 362-0806

  • Hakuaikai Sagara Hospital

    Kagoshima, 892-0833

  • Tokai University Hospital

    Kanagawa, 259-1193

  • National Cancer Center Hospital East

    Kashiwa, 277-8577

  • The Cancer Institute Hospital of JFCR

    Kōtoku, 135-8550

  • Kumamoto University Hospital

    Kumamoto, 860-8556

  • Kure Medical Center And Chugoku Cancer Center

    Kure, 737-0023

  • Mie University Hospital

    Mie, 514-8507

  • Nagoya University Hospital

    Nagoya, 466-8560

  • Nagoya City University Hospital

    Nagoya, 467-8602

  • Hiroshima City Hiroshima Citizens Hospital

    Nakaku, 730-8518

  • NIigata Cancer Center Hospital

    Niigata, 951-8566

  • Okayama University Hospital

    Okayama, 700-8558

  • Gunma Prefectural Cancer Center

    Ōta-ku, 373-8550

  • 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

Italy19 sites

  • IRCCS Istituto Tumori "Giovanni 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

  • IRCCS 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

  • Ospedale San Raffaele

    Milan, 20132

  • Fondazione IRCCS - Istituto Nazionale dei Tumori

    Milan, 20133

  • Centro Ricerca Fase I, Fondazione IRCSS San Gerado dei Tintori

    Monza, 20090

  • AOU "Luigi Vanvitelli"

    Naples, 80131

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

    Naples, 80131

  • AOU Maggiore della Carita

    Novara, 28100

  • Istituto Oncologico Veneto - IRCCS

    Padova, 35128

  • S.O.C Oncologia Medica, Nuovo Ospedale di Prato Santo Stefano

    Prato, 59100

  • Ospedale Generale Provinciale - Macerata

    Province of Macerata, 62100

  • Policlinico di Roma

    Roma, 00161

  • Fondazione Policlinico Universitario Agostino Geme

    Rome, 00168

  • Azienda Ospedaliera Universitaria Senese - Losped

    Siena, 53100

Other trials in Italy

Germany18 sites

  • Helios Klinikum Berlin-Buch

    Berlin, 13125

  • : Gynakologisches Zentrum Bonn, Schwerpunkt Gyn. Onkologie,

    Bonn, 53111

  • Marienhospital Bottrop

    Bottrop, 46236

  • Klinik Frauenheilkunde, Uniklinik ClO, Studienzentrale

    Cologne, 50937

  • Universitätsklinikum Erlangen, Frauen klinik

    Erlangen, 91054

  • Kliniken Essen-Mitte - Evangelische Huyssens-Stift

    Essen, 45136

  • Praxis für interdisziplinäre Onkologie & Hämatolog

    Freiburg im Breisgau, 79110

  • : Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Facharztzentrum Eppendorf

    Hamburg, 20249

  • Nationales Centrum für Tumorerkrankungen

    Heidelberg, 69120

  • Universitätsklinikum Schleswig-Holstein Institut fur Klinische Chermie

    Lübeck, 23538

  • Universitatsklinikum Mannheim GmBH, Frauenklinik

    Mannheim, 68167

  • EV. Krankenhaus Bethesda - Johanniter GmbH, Station 1 Brustzentrum Niederrhein

    Mönchengladbach, 41061

  • Rotkreuzklinikum Munchen Frauenklinik

    München, 80637

  • Klinik und Poliklinik für Frauenheilkunde

    München, 81675

  • Universitätsklinikum Münster, Bereich Senologie an der klinik fur Frauenheilkunde und Gerburtschilfe

    Münster, 48149

  • Universitatsklinikum Tubingen

    Tübingen, 72076

  • St. Josefs-Hospital Wiesbaden GmbH, Gynakologie und Geburtshilfe

    Wiesbaden, 65189

Other trials in Germany

Spain17 sites

  • Hospital Teresa Herrera - Materno Infantil

    A Coruña, 15006

  • Hospital Universitari Dexeus

    Barcelona, 08028

  • Hospital Clinic Barcelona

    Barcelona, 08036

  • Hospital Clínic de Barcelona

    Barcelona, 08036

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 8023

  • Hospital Universitari Vall d'Hebrón

    Barcelona, 8035

  • Hospital Universitario de Basurto

    Bilbao, 48013

  • Hospital Universitari Arnau de Vilanova

    Lleida, 25198

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

  • MD Anderson Cancer Centre Madrid

    Madrid, 28033

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010

  • Hospital General Universitario Morales Meseguer

    Murcia, 30008

  • Hospital Universitario de Canarias

    Santa Cruz de Tenerife, 38320

  • Hospital Unviersitario Virgen del Rocio

    Seville, 41013

  • Hospital Universitario Virgen Macarena

    Seville, 41071

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

France16 sites

  • Sainte Catherine Institut du Cancer Avignon Provence

    Avignon, 84918

  • Centre Hospitalier Régional et Universitaire de Be

    Besançon, 25030

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33000

  • Hôpital Morvan, Institut de cancérologie

    Brest, 29200

  • Centre de Lutte contre le Cancer - François Bacles

    Caen, 14000

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Centre Leon Berard

    Lyon, 69373

  • Institut Paoli-Calmettes

    Marseille, 13273

  • Centre de Cancérologie du Grand Montpellier

    Montpellier, 34070

  • Institut Régional du Cancer de Montpellier

    Montpellier, 34298

  • Hôpital Privé du Confluent

    Nantes, 44202

  • Hospices Civils de Lyon, Hôpital Lyon Sud

    Pierre-Bénite, 69495

  • 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

Brazil14 sites

  • Hospital Araújo Jorge - Associacao de Combate ao Cancer em Goias - ACCG

    Goiânia, 74605-070

  • Centro de Pesquisa Clinica Em Oncologia - ONCOSITE

    Ijuí, 98700-000

  • Hospital de Clinicas de Porto Alegre - HCPA

    Itajaí, 88301-220

  • Centro de Pesquisas Clinicas da Fundacao Doutor Amaral Carvalho - Hospital Amarval Carvalho

    Jaú, 17210080

  • Associacao Hosptialar Moinos de Vento - Hospital Moinhos de Vento

    Porto Alegre, 90035-00

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, 90035-903

  • Hospital Sao Lucas da PUCRS

    Porto Alegre, 90610001

  • Instituto Nacional de Câncer - Brazil

    Rio de Janeiro

  • Núcleo de Oncologia da Bahia

    Salvador, 40170170

  • CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - Centro Universitário FMABC

    Santo André, 09060-650

  • Real e Benemerita Associacao Portuguesa de Beneficencia - Hospital Beneficencia 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 Câncer de Barretos

    São Paulo, 14784400

  • Nucleo de Pesquisa Clinica da Rede Sao Camilo

    São Paulo, 4014002

Other trials in Brazil

Australia12 sites

  • Cancer Research SA (CRSA)

    Adelaide, South Australia, 5000

  • Border Medical Oncology

    Albury, New South Wales, 2640

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • Icon Cancer Centre Hobart

    Hobart, Tasmania, 7000

  • 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 Hospital - North Sydney

    North Sydney, New South Wales, 2060

  • Peter MacCallum Cancer Centre

    Parkville, Victoria, 3050

  • Mater Misericordiae Limited and Mater Research Limited

    South Brisbane, Queensland, 4101

  • GenesisCare - North Shore

    St Leonards, New South Wales, 2065

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Canada12 sites

  • Tom Baker Cancer Centre

    Calgary, T2N 5G2

  • 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

    Montreal, H3T 1E2

  • McGill University Health Centre

    Montreal, H4A 3J1

  • Princess Margaret Cancer Centre - University Health Network

    Ontario, M5G 2M9

  • Ottawa Hospital - General Campus

    Ottawa, K1H 8L6

  • Sunnybrook Research Institute

    Toronto, M4N 3M5

  • Mount Sinai Hospital

    Toronto, M5G 1X5

  • British Columbia Cancer - Vancouver

    Vancouver, V5Z 4E6

Other trials in Canada

Turkey (Türkiye)12 sites

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

    Adana, 1120

  • Ankara Il Saglik Mudurlugu SBU Gulhane Egitim Ve A

    Ankara, 6010

  • Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

    Ankara, 6200

  • Memorial Ankara Hastanesi

    Ankara, 6520

  • 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

  • VKV Amerikan Hastanesi

    Şişli, 34365

Other trials in Turkey (Türkiye)

Mexico10 sites

  • Icaro Investigaciones en Medicina S.A. de C.V.

    Chihuahua City, 31000

  • 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

Israel9 sites

  • Soroka Medical Center

    Beersheba, 8410101

  • Rambam Health Care Campus

    Haifa, 3109601

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • 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

Belgium8 sites

  • Institut Jules Bordet

    Anderlecht, 1070

  • 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

Malaysia8 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

  • Hospital Wanita dan Kanak-Kanak Sabah

    Sabak Bernam, 88996

  • Sarawak General Hospital

    Sarawak, 93586

Other trials in Malaysia

South Korea8 sites

  • National Cancer Center - Korea

    Goyang-si Gyeonggi-do, 10408

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

  • Severance Hospital

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • Korea University Anam Hospital

    Seoul, 2841

  • Seoul National University Hospital

    Seoul, 3080

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

    Seoul, 6591

Other trials in South Korea

Taiwan8 sites

  • Changhua Christian Hospital

    Changhua, 50006

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • Taipei Medical University-Shuang Ho Hospital

    New Taipei City, 235

  • National Cheng Kung University Hospital

    Tainan, 704

  • Chi Mei Hospital, Liouying

    Tainan, 73657

  • National Taiwan University Hospital

    Taipei, 100

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Linkou Chang Gung Memorial Hospital

    Taoyuan, 333

Other trials in Taiwan

United Kingdom8 sites

  • NHS Lothian

    Edinburgh, EH4 2XU

  • Clinical Trials Unit Lvl 0 Cancer Research UK Beatson Institute

    Glasgow, G12 0YN

  • Leeds Teaching Hospitals NHS Trust

    Leeds, LS9 7TF

  • : Barts Health NHS Trust, St Hospital

    London, EC1M 6BQ

  • Royal Free London NHS Foundation Trust

    London, NW2 2QG

  • Guy's and Saint Thomas' NHS Foundation Trust

    London, SE1 9RT

  • University College London Hospitals

    London, WC1E 6BT

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG5 1PB

Other trials in United Kingdom

Poland7 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

  • Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie

    Poznan, 61- 866

  • Mazowiecki Szpital Wojewódzki im. w. Jana Pawa II w

    Siedlce, 08-110

  • Narodowy Instytut Onkologii im.Marii Marii Sklodowskiejs

    Warsaw, 02-781

  • Wojskowy Instytut Medyczny

    Warsaw, 04-141

Other trials in Poland

Argentina6 sites

  • Hospital Británico de Buenos Aires

    Buenos Aires, 1426

  • Instituto de Oncología Ángel H. Roffo

    CABA, 1417

  • Fundacion CORI para la Investigacioy y Prevención del Cancer

    Capital, F5300COE

  • Instituto de Oncologia de Rosario

    Rosario, 2000

  • CAIPO Centro Para La Atención Integral Del Pacient

    San Miguel de Tucumán, 4000

  • Clinica Viedma

    Viedma, 8500

Other trials in Argentina

Czechia6 sites

  • Masarykuv Onkologicky Ustav, Klinika Komplexni Onkologicke Pece

    Brno, 65653

  • Fakultní Nemocnice Hradec Králové

    Hradec Králové, 500 05

  • Fakultní Thomayerova nemocnice

    Hradec Králové, 50005

  • Fakultni nemocnice Olomouc, Onkologicka klinika

    Olomouc, 77520

  • Fakultní Nemocnice Královské Vinohrady, Radioterapeuticka a onkologicka klinika

    Prague, 100 34

  • Vseobecna Fakultni Nemocnice v Praze, Onkologicka klinika

    Prague, 12808

Other trials in Czechia

Austria5 sites

  • Medizinische Universität Innsbruck

    Innsbruck, 06020

  • Ordensklinikum Linz GmbH Barmherzige Schwestern

    Linz, 4010

  • Landeskrankenhaus Salzburg

    Salzburg, A-5020

  • Universitätsklinikum Sankt Pölten

    Sankt Pölten, 3100

  • Medizinische Universität Wien

    Vienna, 1090

Other trials in Austria

Chile5 sites

  • Oncovida - Santiago

    Providencia, 7510035

  • Clínica Alemana

    Santiago, 7630000

  • Clínica IRAM

    Santiago

  • Centro de Cancer Pontificia Universidad Catolica

    Santiago Region, 8330032

  • James Lind Centro de Investigacion del Cancer

    Temuco

Other trials in Chile

Switzerland5 sites

  • Kantonsspital Baden

    Baden, 5404

  • Kantonsspital Baselland - Standort Liestal

    Liestal, 4410

  • Kantonsspital Sankt Gallen

    Sankt Gallen, 9007

  • Kantonsspital Winterthur

    Winterthur, 8401

  • Brust-Zentrum Zurich

    Zurich, 8008

Other trials in Switzerland

Hong Kong4 sites

  • Department of Medicine, Queen Mary Hospital

    Hong Kong, 999077

  • Hong Kong Sanatorium and Hospital

    Hong Kong

  • Tuen Mun Hospital

    Hong Kong

  • Prince of Wales Hospital - Hong Kong

    New Territories, 999077

Other trials in Hong Kong

Hungary4 sites

  • Orszagos Onkologiai Intezet

    Budapest, 1122

  • Uzsoki Utcai Kórház

    Budapest, 1145

  • Debreceni Egyetem Klinikai Központ

    Debrecen, 4032

  • Petz Aladár Egyetemi Oktató Kórház - Gy?r

    Győr, 9024

Other trials in Hungary

Netherlands4 sites

  • Amphia Ziekenhuis - Breda Langendijk

    Breda, 4818 CK

  • Universitair Medisch Centrum Groningen

    Groningen, 9700 RB

  • Medisch Centrum Leeuwarden

    Leeuwarden, 8934 AD

  • Erasmus Medisch Centrum

    Rotterdam

Other trials in Netherlands

South Africa3 sites

  • Hopelands Cancer Centre

    Hilton, 3245

  • The Medical Oncology Centre of Rosebank

    Johannesburg, 2196

  • University of Pretoria

    Pretoria, 0002

Other trials in South Africa

Puerto Rico1 site

  • Ponce Medical School Foundation Inc.

    Ponce, PR, 00716

Other trials in Puerto Rico

About this study

Official title: A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express PD-L1

The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician's choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (PD-L1).

Being tested
Sacituzumab Govitecan-hziy, Pembrolizumab, Paclitaxel, nab-Paclitaxel, Gemcitabine
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

  • PembrolizumabDrug

    Also called KEYTRUDA®

    Administered intravenously

  • PaclitaxelDrug

    Also called Taxol®

    Administered intravenously

  • nab-PaclitaxelDrug

    Also called Abraxane®

    Administered intravenously

  • GemcitabineDrug

    Also called Gemzar

    Administered intravenously

  • CarboplatinDrug

    Administered intravenously

Study groups in NCT05382286
Study groupRoleWhat they receive
Sacituzumab Govitecan-hziy (SG) + PembrolizumabExperimentalParticipants will receive SG 10 mg/kg on Days 1 and 8 of 21-day cycles and pembrolizumab 200 mg on Day 1 of 21-day cycles Pembrolizumab will be administered for a maximum of 35 cycles.
Receives: Drug: Sacituzumab Govitecan-hziy; Drug: Pembrolizumab
Pembrolizumab + Treatment of Physician's Choice (TPC)Active comparatorParticipants will receive pembrolizumab 200 mg on Day 1 of each 21-day cycle (maximum 35 cycles) plus TPC determined prior to randomization from 1 of the 3 allowed regimens: * Paclitaxel 90 mg/m^2 on Days 1, 8, and 15 of 28-day cycles * nab-Paclitaxel 100 mg/m^2 on Days 1, 8, and 15 of 28-day cycles * Gemcitabine 1000 mg/m^2 + carboplatin area under the curve (AUC) 2 on Days 1 and 8 of 21-day cycles
Receives: Drug: Pembrolizumab; 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 33 months

Secondary outcomes (11)

  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 53 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 complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response.

    Measured: Randomization up to approximately 53 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 objective PD or death from any cause (whichever comes first).

    Measured: Randomization up to approximately 53 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 53 months

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

    Measured: First dose date up to 53 months plus 30 days

  6. Percentage of Participants Experiencing Clinical Laboratory Abnormalities

    Measured: First dose date up to 53 months plus 30 days

  7. Time to Deterioration (TTD) in Global Health Status/Quality of Life (QoL) Scale 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) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the participant).

    Measured: Randomization up to approximately 53 months

  8. TTD of Pain Score as Measured by 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) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the participant).

    Measured: Randomization up to approximately 53 months

  9. TTD of Fatigue Score as Measured by 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) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (ie, a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (ie, a worse state of the participant).

    Measured: Randomization up to approximately 53 months

  10. TTD of Physical Functioning Domain Score as Measured by 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) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (ie, a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (ie, a worse state of the participant).

    Measured: Randomization up to approximately 53 months

  11. TTD of Role Functioning Score as Measured by 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) resulting in 5 functional scales, 1 global health status scale, 3 symptom scales, and 6 single items. Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (ie, a better state of the participant), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (ie, a worse state of the participant).

    Measured: Randomization up to approximately 53 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 start25 Jul 2022
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2027 (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
443 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05382286
Sponsor's protocol ID
GS-US-592-6173
Other IDs
2021-005742-14, KEYNOTE-D19, jRCT2041220123, MK-3475-D19, 2023-504194-21, 2023
Acronym
ASCENT-04
Status last verified
Sep 2025
First submitted
16 May 2022
Last updated
18 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tolaney SM, de Azambuja E, Kalinsky K, Loi S, Kim SB, Yam C, Rapoport B, Im SA, Pistilli B, Mchayleh W, Cescon DW, Watanabe J, Banuelas MAL, Freitas-Junior R, Salvador Bofill J, Afshari M, Gary D, Wang L, Lai C, Schmid P; ASCENT-04/KEYNOTE-D19 Clinical Trial Investigators. Sacituzumab Govitecan plus Pembrolizumab for Advanced Triple-Negative Breast Cancer. N Engl J Med. 2026 Jan 22;394(4):354-366. doi: 10.1056/NEJMoa2508959.

    PubMed 41564397

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sacituzumab Govitecan-hziy, Pembrolizumab and Paclitaxel in people with Triple Negative Breast Cancer and PD-L1 Positive, run by Gilead Sciences at 504 sites in 28 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 9 inclusion and 11 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 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 504 sites in United States, Japan, Italy, Germany, Spain and 23 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 33 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 NCT05382286, 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 18 Sep 2025.

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