STATUS Recruitment Complete

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)

Gilead Clinical Study Information Center:
Monday – Friday, 5am – 6pm PT
Email: [email protected]

STATUS

Recruitment Complete

GILEAD STUDY ID

GS-US-592-6238

Gilead Clinical Study Information Center:
Monday – Friday, 5am – 6pm PT
Email: [email protected]

LAST UPDATED

April 06, 2026

Clinicaltrials.gov ID

NCT05382299

EudraCT ID

2021-005743-79

CTSID

2023-504195-14

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

Study details

Medical Condition

Triple Negative Breast Cancer, PD-L1 Negative

Gender

N/A

Date

July 2022 - July 2028

Study Type

Interventional

Study Phase

Phase 3

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

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)

For more information, please contact the

For more information, please contact the

OVERVIEW

PROTOCOL SUMMARY

Participation requirements

Study details

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.