ACTIVE_NOT_RECRUITING

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

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Conditions

Triple Negative Breast CancerPD-L1 Negative

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1

Quick Facts

Study Start:2022-07-20
Study Completion:2028-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05382299

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Individuals, regardless of race and ethnic group, with previously untreated locally advanced, inoperable or metastatic triple-negative breast cancer (TNBC)
  2. * 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
  3. * Centrally confirmed TNBC and PD-L1 status on fresh or archival tissue
  4. * 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
  5. * Individuals presenting with de novo metastatic TNBC are eligible
  6. * 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
  7. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  8. * Demonstrates adequate organ function
  9. * Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception
  10. * Individuals with human immunodeficiency virus (HIV) must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease
  1. * Positive serum pregnancy test or women who are lactating
  2. * Received systemic anticancer treatment within the previous 6 months or radiation therapy within 2 weeks prior to enrollment
  3. * Have not recovered from adverse events (AEs) due to a previously administered agent at the time study entry
  4. * 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
  5. * Previously received topoisomerase 1 inhibitors or antibody drug conjugates containing a topoisomerase inhibitor
  6. * Active second malignancy
  7. * Active serious infection requiring antibiotics
  8. * Positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease
  9. * Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection

Contacts and Locations

Principal Investigator

Gilead Study Director
STUDY_DIRECTOR
Gilead Sciences

Study Locations (Sites)

Arizona Oncology Associates, PC-Hope,1845 W Orange Grove Rd
Tucson, Arizona, 85704
United States
Arizona Oncology Associates, PC-Hope,2070 W. Rudasill Rd.
Tucson, Arizona, 85704
United States
Arizona Oncology Associates, PC-Hope
Tucson, Arizona, 85711
United States
Arizona Oncology Associates, PC-Hope,1620 West St. Mary's Road
Tucson, Arizona, 85745
United States
University of California Los Angeles - Jonsson Comprehensive Cancer Center,201 S. Buena Vista Street, Suite 200
Burbank, California, 91505
United States
University of California San Diego Moores Cancer
La Jolla, California, 92093
United States
University of California Los Angeles - Jonsson Comprehensive Cancer Center,24302 Paseo de Valencia, Suite 200
Laguna Hills, California, 91505
United States
University of California Los Angeles - Jonsson Comprehensive Cancer Center,892 Aerovista Place, Suite 240
San Luis Obispo, California, 93401
United States
University of California Los Angeles - Jonsson Comprehensive Cancer Center,2020 Santa Monica Blvd, Suite 600
Santa Monica, California, 90404
United States
University of California Los Angeles - Jonsson Comprehensive Cancer Center,2336 Santa Monica, Suites 302 and 304
Santa Monica, California, 90404
United States
University of California Los Angeles - Jonsson Comprehensive Cancer Center
Santa Monica, California, 90404
United States
Torrance Memorial Physician Network - Cancer Care
Torrance, California, 90505
United States
University of California Los Angeles - Jonsson Comprehensive Cancer Center,1250 La Venta Dr, Suite 100
Westlake Village, California, 91361
United States
Rocky Mountain Cancer Centers,1700 South Potomac Street
Aurora, Colorado, 80012
United States
Rocky Mountain Cancer Centers
Boulder, Colorado, 80303
United States
Rocky Mountain Cancer Centers,2312 N. Nevada Avenue
Colorado Springs, Colorado, 80907
United States
Rocky Mountain Cancer Centers,6031 E. Woodman Rd.
Colorado Springs, Colorado, 80923
United States
Rocky Mountain Cancer Centers,4700 E. Hale Parkway
Denver, Colorado, 80220
United States
Rocky Mountain Cancer Centers,11750 West 2nd Place
Lakewood, Colorado, 80228
United States
Rocky Mountain Cancer Centers,22 West Dry Creek Circle
Littleton, Colorado, 80120
United States
Rocky Mountain Cancer Centers,10107 Ridge Gate Parkway
Lone Tree, Colorado, 80124
United States
Rocky Mountain Cancer Centers,2030 Mountain View Ave Ste 210
Longmont, Colorado, 80124
United States
Rocky Mountain Cancer Centers,3676 Parker Blvd
Pueblo, Colorado, 81008
United States
Rocky Mountain Cancer Centers,525 W. 15th Street
Pueblo, Colorado, 81008
United States
Rocky Mountain Cancer Centers,8820 Huron Street
Thornton, Colorado, 80260
United States
AdventHealth Medical Group
Altamonte Springs, Florida, 32701
United States
Florida Cancer Specialists - North Region Research Office,750 Orienta Ave
Altamonte Springs, Florida, 32701
United States
Florida Cancer Specialists,9776 Bonita Beach Road Southeast Suite 201 A
Bonita Springs, Florida, 34135
United States
Florida Cancer Specialists,3630 Manatee Avenue West
Bradenton, Florida, 34205
United States
Florida Cancer Specialists,5985 Silver Falls Run
Bradenton, Florida, 34211
United States
Florida Cancer Specialists - North Region Research Office,403 S. Kings Ave.
Brandon, Florida, 33511
United States
Florida Cancer Specialists,1030 Commerce Creek Blvd
Cape Coral, Florida, 33909
United States
Florida Cancer Specialists - North Region Research Office,3280 McMullen Booth Road
Clearwater, Florida, 33761
United States
Florida Cancer Specialists
Fort Myers, Florida, 33901
United States
Florida Cancer Specialists,8981 Colonial Center Drive
Fort Myers, Florida, 33905
United States
Florida Cancer Specialists,8260 Gladiolus Dr
Fort Myers, Florida, 33908
United States
Florida Cancer Specialists - North Region Research Office,6420 W. Newberry Road
Gainesville, Florida, 32605
United States
Florida Cancer Specialists - North Region Research Office,100 Highland Avenue
Largo, Florida, 33770
United States
Florida Cancer Specialists - North Region Research Office,521 North Lecanto Highway
Lecanto, Florida, 34461
United States
Florida Cancer Specialists,1100 Goodlette Road
Naples, Florida, 34102
United States
Florida Cancer Specialists,681 4th Avenue North
Naples, Florida, 34102
United States
Florida Cancer Specialists - North Region Research Office,4945 SW 49th Place
Ocala, Florida, 34474
United States
Florida Cancer Specialists - North Region Research Office,2824 Enterprise Rd
Orange City, Florida, 32763
United States
AdventHealth Medical Group,2501 North Orange Ave
Orlando, Florida, 32804
United States
Florida Cancer Specialists - North Region Research Office,70 W. Gore Street
Orlando, Florida, 32806
United States
Florida Cancer Specialists,22395 Edgewater Drive
Port Charlotte, Florida, 33980
United States
Florida Cancer Specialists,600 North Cattlemen Road
Sarasota, Florida, 34232
United States
Florida Cancer Specialists,1970 Golf Street
Sarasota, Florida, 34236
United States
Florida Cancer Specialists - North Region Research Office,7154 Medical Center Drive
Spring Hill, Florida, 34608
United States
Florida Cancer Specialists - North Region Research Office,1201 Fifth Avenue North
St. Petersburg, Florida, 33705
United States
Florida Cancer Specialists - North Region Research Office
St. Petersburg, Florida, 33705
United States
Florida Cancer Specialists - North Region Research Office,3402 West Dr. Martin Luther King Jr. Boulevard
Tampa, Florida, 33607
United States
Florida Cancer Specialists - North Region Research Office,4100 Waterman Way
Tavares, Florida, 32778
United States
Florida Cancer Specialists - North Region Research Office,1400 US Highway 441 N
The Villages, Florida, 32159
United States
Florida Cancer Specialists - North Region Research Office,9320 State Road 54
Trinity, Florida, 34655
United States
Florida Cancer Specialists,901 South Tamiami Trail
Venice, Florida, 34285
United States
Florida Cancer Specialists,836 Sunset Lake Blvd
Venice, Florida, 34292
United States
Florida Cancer Specialists - North Region Research Office,460 N Orlando Ave
Winter Park, Florida, 32789
United States
Northside Hospital,125 King Avenue
Athens, Georgia, 30606
United States
Northside Hospital,5670 Peachtree Dunwoody Rd.
Atlanta, Georgia, 30342
United States
Northside Hospital
Atlanta, Georgia, 30342
United States
Northside Hospital,308 Deep South Farm Rd, Suite 200
Blairsville, Georgia, 30512
United States
Northside Hospital,228 Riverstone Dr.
Canton, Georgia, 30114
United States
Northwest Georgia Oncology Northwest Georgia Oncology Centers, PCCenters, PC,157 Clinic Avenue
Carrollton, Georgia, 30117
United States
Northwest Georgia Oncology Northwest Georgia Oncology Centers, PCCenters, PC,100 Market Place Blvd
Cartersville, Georgia, 30121
United States
Northside Hospital,1505 Northside Blvd, Suite 4600
Cumming, Georgia, 30041
United States
Northside Hospital,3855 Pleasant Hill Rd., Suite 480
Duluth, Georgia, 30096
United States
Northside Hospital,308 Coliseum Dr.
Macon, Georgia, 31217
United States
Northwest Georgia Oncology Northwest Georgia Oncology Centers, PCCenters, PC
Marietta, Georgia, 30060
United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, 60611
United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University,1 Kish Hospital Drive
DeKalb, Illinois, 60115
United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University,10 Health Services Drive
DeKalb, Illinois, 60115
United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University,300 Randall Road
Geneva, Illinois, 60134
United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University,304 Randall Road
Geneva, Illinois, 60134
United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University,1000 N. Westmoreland Road
Lake Forest, Illinois, 60045
United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University,4405 Weaver Parkway
Warrenville, Illinois, 25731
United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University,4455 Weaver Parkway
Warrenville, Illinois, 60555
United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University,25 N Winfield Road
Winfield, Illinois, 60190
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
Norton Cancer Institute - Saint Matthews,234 E. Gray Strret
Louisville, Kentucky, 40202
United States
Norton Cancer Institute - Saint Matthews,676 S. Floyd Street
Louisville, Kentucky, 40202
United States
Norton Cancer Institute - Saint Matthews
Louisville, Kentucky, 40207
United States
Norton Cancer Institute - Saint Matthews,4955 Norton Healthcare Blvd
Louisville, Kentucky, 40241
United States
Cancer Institute Ascension Saint Agnes
Baltimore, Maryland, 21229
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
The West Clinic, PLLC dba West Cancer Center,7668 Airways Blvd
Southaven, Mississippi, 38671
United States
New York Cancer & Blood Specialists - Port Jeffers,72 East Main St.
Babylon, New York, 11702
United States
New York Cancer & Blood Specialists - Port Jeffers,1 Delaware Dr.
New Hyde Park, New York, 11042
United States
New York Cancer & Blood Specialists - Port Jeffers,365 East Main St.
Patchogue, New York, 11772
United States
New York Cancer & Blood Specialists - Port Jeffers,1500 Rte, 112, Building 4
Port Jefferson, New York, 11776
United States
New York Cancer & Blood Specialists - Port Jeffers,49 Rte. 347, Newconset Hwy
Port Jefferson Station, New York, 11776
United States
New York Cancer & Blood Specialists - Port Jeffers
Port Jefferson Station, New York, 11776
United States
New York Cancer & Blood Specialists - Port Jeffers,750 Old County Rd. Suite 4
Riverhead, New York, 11901
United States
New York Cancer & Blood Specialists - Port Jeffers,12 East 86th St, Suite 4
The Bronx, New York, 10028
United States
New York Cancer & Blood Specialists - Port Jeffers,2330 Eastchester Road, Suite 360
The Bronx, New York, 10469
United States
Novant Health Cancer Institute - Forsyth,125 Queens Road, Suite 650
Charlotte, North Carolina, 28204
United States
Novant Health Cancer Institute - Forsyth,2131 S. 17th Street
Wilmington, North Carolina, 28401
United States
Novant Health Cancer Institute - Forsyth
Winston-Salem, North Carolina, 27103
United States
Magee-Womens Hospital of UPMC,2500 West 12th Street
Erie, Pennsylvania, 16505
United States
Magee-Womens Hospital of UPMC,201 State Street, 6 Main
Erie, Pennsylvania, 16550
United States
Magee-Womens Hospital of UPMC,4300 Londonberry Road
Harrisburg, Pennsylvania, 17109
United States
Magee-Womens Hospital of UPMC,2035 Technology Parkway
Mechanicsburg, Pennsylvania, 17050
United States
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
United States
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
United States
Magee-Womens Hospital of UPMC,5115 Centre Avenue
Pittsburgh, Pennsylvania, 15232
United States
Magee-Womens Hospital of UPMC,1703 Innovation Drive
York, Pennsylvania, 17408
United States
Tennessee Oncology, PLLC,103 Natchez Park Drive
Dickson, Tennessee, 37055
United States
Tennessee Oncology, PLLC,4488 Carothers Parkway
Franklin, Tennessee, 37067
United States
Tennessee Oncology, PLLC,225 Big Station Camp Blvd
Gallatin, Tennessee, 37066
United States
The West Clinic, PLLC dba West Cancer Center
Germantown, Tennessee, 38138
United States
Tennessee Oncology, PLLC,353 New Shackle Island Road
Hendersonville, Tennessee, 37075
United States
Tennessee Oncology, PLLC,5653 First Blvd.
Hermitage, Tennessee, 37076
United States
Tennessee Oncology, PLLC,103 Physicians Way
Lebanon, Tennessee, 37090
United States
Tennessee Oncology, PLLC,1840 Medical Center Parkway
Murfreesboro, Tennessee, 37129
United States
Tennessee Oncology, PLLC,2004 Hayes Street
Nashville, Tennessee, 37203
United States
Tennessee Oncology, PLLC,SCRI Oncology Partners
Nashville, Tennessee, 37203
United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203
United States
Tennessee Oncology, PLLC,4220 Harding Rd
Nashville, Tennessee, 37205
United States
Tennessee Oncology, PLLC,3443 Dickerson Road
Nashville, Tennessee, 37207
United States
Tennessee Oncology, PLLC,397 Wallace Road
Nashville, Tennessee, 37211
United States
Tennessee Oncology, PLLC,120 Frank Martin Road
Shelbyville, Tennessee, 37160
United States
Tennessee Oncology, PLLC,300 Stonecrest Blvd
Smyrna, Tennessee, 37167
United States
Texas Oncology PA,901 West 38th Street
Austin, Texas, 78705
United States
Texas Oncology PA
Austin, Texas, 78731
United States
Texas Oncology PA,4101 James Casey, Suite 100
Austin, Texas, 78745
United States
Virginia Oncology Associates,744 N. Battlefield Blvd
Chesapeake, Virginia, 23320
United States
Virginia Oncology Associates,1051 Loftis Blvd Suite 100
Newport News, Virginia, 23606
United States
Virginia Oncology Associates
Norfolk, Virginia, 23502
United States
Virginia Oncology Associates,1950 Glenn Mitchell Drive
Virginia Beach, Virginia, 23456
United States

Collaborators and Investigators

Sponsor: Gilead Sciences

  • Gilead Study Director, STUDY_DIRECTOR, Gilead Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-20
Study Completion Date2028-07

Study Record Updates

Study Start Date2022-07-20
Study Completion Date2028-07

Terms related to this study

Additional Relevant MeSH Terms

  • Triple Negative Breast Cancer
  • PD-L1 Negative