Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/NSABP B-63)

Triple Negative Breast Cancer Clinical Trial

Official title:

A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05633654
• Other study ID #: GS-US-595-6184
• Secondary ID: 2024-512279-10
• Status: Recruiting
• Phase: Phase 3
• Start date: December 12, 2022
• Est. completion date: August 2031

Study information

• Verified date: May 2024
• Source: Gilead Sciences
• Contact: Gilead Clinical Study Information Center
• Phone: 1-833-445-3230 (GILEAD-0)
• Email: GileadClinicalTrials[@]gilead.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to find out if the experimental product, sacituzumab govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician's choice (TPC) which includes either pembrolizumab or pembrolizumab plus capecitabine in participants with triple negative breast cancer that still remains after surgery and pre-surgical treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1514
• Est. completion date: August 2031
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Age > 18 years, with residual invasive triple negative breast cancer (TNBC) in the breast or lymph nodes after neoadjuvant therapy and surgery:

• TNBC criteria for the study is defined as estrogen receptor (ER) and progesterone receptor (PR) < 10%, human epidermal growth factor receptor 2 (HER2)-negative per American Society of Clinical Oncology and College of American Pathologists (ASCO/CAP) guidelines (immunohistochemistry (IHC) and/or in situ hybridization (ISH)).

• Adequate excision and surgical removal of all clinically evident of disease in the breast and/or lymph nodes and have adequately recovered from surgery.

• Submission of both pre-neoadjuvant treatment diagnostic biopsy and resected residual invasive disease tissue.

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

• Individuals must have received appropriate radiotherapy and have recovered prior to starting study treatment.

• Adequate organ function.

Key Exclusion Criteria:

• Stage IV (metastatic) breast cancer as well as history of any prior (ipsi- or contralateral) invasive breast cancer.

• Prior treatment with another stimulatory or coinhibitory T-cell receptor agent (eg, cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), OX-40, cluster of differentiation 137 (CD137), prior treatment with any HER2-directed agent, prior or concurrent treatment with any endocrine therapy agent.

• Evidence of recurrent disease following preoperative therapy and surgery.

• Prior treatment with topoisomerase 1 inhibitors or antibody-drug conjugates (ADCs) containing a topoisomerase inhibitor.

• Individuals with germline breast cancer gene (BRCA) mutations.

• Myocardial infarction or unstable angina pectoris within 6 months of enrollment or history of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias or Left ventricular ejection fraction (LVEF) of < 50%

• Active serious infections requiring anti-microbial therapy.

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Drug:
• Sacituzumab govitecan-hziy (SG)
Administered intravenously
• Pembrolizumab
Administered intravenously
• Capecitabine
Tablets administered orally

Locations

Country	Name	City	State
United States	Hendrick Health System	Abilene	Texas
United States	University of New Mexico	Albuquerque	New Mexico
United States	New York Oncology Hematology (NYOH)	Amsterdam	New York
United States	ThedaCare Regional Cancer Center	Appleton	Wisconsin
United States	University Cancer & Blood Center, LLC.	Athens	Georgia
United States	Northside Hospital	Atlanta	Georgia
United States	Piedmont Cancer Institute	Atlanta	Georgia
United States	University of Colorado Cancer Center	Aurora	Colorado
United States	Texas Oncology	Austin	Texas
United States	Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center	Baltimore	Maryland
United States	Medstar Franklin Square Medical Center	Baltimore	Maryland
United States	Sinai Hospital of Baltimore, Inc.	Baltimore	Maryland
United States	St. Agnes Hospital	Baltimore	Maryland
United States	Mary Bird Perkins Cancer Center	Baton Rouge	Louisiana
United States	St. Charles Health System, Inc. DBA St. Charles Medical Center	Bend	Oregon
United States	American Oncology Partners of Maryland, PA	Bethesda	Maryland
United States	Saint Luke's University Hospital	Bethlehem	Pennsylvania
United States	Alabama Oncology	Birmingham	Alabama
United States	St Lukes Mountain States Tumor Institute	Boise	Idaho
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	Mercy Medical Center	Cedar Rapids	Iowa
United States	Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	University of Illinois	Chicago	Illinois
United States	Good Samaritan Hospital	Cincinnati	Ohio
United States	Oncology Hematology Care, Inc.	Cincinnati	Ohio
United States	Morton Plant Hospital - Bay Care	Clearwater	Florida
United States	Kootenai Health	Coeur d'Alene	Idaho
United States	Anita Stewart Oncology Center	Columbus	Ohio
United States	Ohio Health Research Institute	Columbus	Ohio
United States	Samaritan Hospital	Corvallis	Oregon
United States	Norwalk Hospital	Danbury	Connecticut
United States	Mission Cancer & Blood - John Stoddard Cancer Center	Des Moines	Iowa
United States	PIH Health Whittier Hospital	Downey	California
United States	Regional Cancer Care Associates LLC	East Brunswick	New Jersey
United States	Hematology Oncology Associates of Central New York, PC	East Syracuse	New York
United States	Texas Oncology	El Paso	Texas
United States	Willamette Valley Cancer Institute and Research Center	Eugene	Oregon
United States	NorthShore University Healthsystem	Evanston	Illinois
United States	San Juan Oncology Associates	Farmington	New Mexico
United States	Hunterdon Medical Center	Flemington	New Jersey
United States	Summit Medical Group, P.A.	Florham Park	New Jersey
United States	Compassionate Cancer Care Medical Group - Inc	Fountain Valley	California
United States	James M Stockman Cancer Institute	Frederick	Maryland
United States	Palo Verde Hematology Oncology	Glendale	Arizona
United States	Cancer and Hematology Centers of Western Michigan	Grand Rapids	Michigan
United States	Ascension	Grosse Pointe Woods	Michigan
United States	Mary Lanning Healthcare - Morrison Cancer Center	Hastings	Nebraska
United States	MD Anderson Cancer Center	Houston	Texas
United States	Clearview Cancer Institute	Huntsville	Alabama
United States	Investigative Clinical Research of Indiana, LLC	Indianapolis	Indiana
United States	Cancer Specialists of North Florida	Jacksonville	Florida
United States	Jupiter Medical Center	Jupiter	Florida
United States	Center for Biomedical Research, LLC	Knoxville	Tennessee
United States	University of Tennessee	Knoxville	Tennessee
United States	Providence Regional Cancer System	Lacey	Washington
United States	IU Health Arnett Hospital	Lafayette	Indiana
United States	Lancaster General Health	Lancaster	Pennsylvania
United States	University of Kentucky	Lexington	Kentucky
United States	Los Angeles Cancer Network	Los Angeles	California
United States	USC Norris Comprehensive Cancer Center	Los Angeles	California
United States	Norton Healthcare, Inc.	Louisville	Kentucky
United States	Joe Arrington Cancer Research and Treatment Center	Lubbock	Texas
United States	Minnesota Oncology Hematology, PA	Maplewood	Minnesota
United States	Northwest Georgia Oncology Centers, PC	Marietta	Georgia
United States	Asante Rogue Regional Medical Center	Medford	Oregon
United States	Mount Sinai Comprehensive Cancer Center	Miami Beach	Florida
United States	MultiCare Regional Cancer Center - Tacoma	Middletown	Ohio
United States	Virginia Piper Cancer Center (Allina Health)	Minneapolis	Minnesota
United States	Edward Hospital	Naperville	Illinois
United States	Rutgers Health	New Brunswick	New Jersey
United States	University Medical Center New Orleans	New Orleans	Louisiana
United States	Laura and Isaac Perlmutter Cancer Canter	New York	New York
United States	Nebraska Methodist Hospital (change from Chi Health Bergan Mercy)	Omaha	Nebraska
United States	Oncology Hematology West - Methodist	Omaha	Nebraska
United States	Midland Florida Clinical Research Center, L	Orange City	Florida
United States	Orlando Health	Orlando	Florida
United States	Mercy Health	Paducah	Kentucky
United States	Cancer Care Centers of Brevard, Inc	Palm Bay	Florida
United States	Sacred Heart Medical Oncology Group	Pensacola	Florida
United States	University of Pennsylvania Abramson Cancer Center	Philadelphia	Pennsylvania
United States	FirstHealth Outpatient Cancer Center	Pinehurst	North Carolina
United States	Sylvester Comprehensive Cancer Center	Plantation	Florida
United States	Providence Cancer Institute - Oncology Clinical Trials	Portland	Oregon
United States	Arizona Oncology Associates	Prescott Valley	Arizona
United States	Providence Health	Providence	Rhode Island
United States	Northwest Medical Specialties, PLLC	Puyallup	Washington
United States	UNC Rex Cancer Center	Raleigh	North Carolina
United States	Monument Health Cancer Care Institute	Rapid City	South Dakota
United States	Emad Ibrahim, MD, INC	Redlands	California
United States	Cancer Care & Hematology Specialists	Reno	Nevada
United States	University of Washington	Renton	Washington
United States	Virginia Commonwealth University Medical Center	Richmond	Virginia
United States	West Suburban Medical Center- River Forest	River Forest	Illinois
United States	Oncology and Hematology Associates of Southwest Virginia, Inc	Roanoke	Virginia
United States	Lipson Cancer Institute - Linden Oaks	Rochester	New York
United States	UNC Nash Cancer Center	Rocky Mount	North Carolina
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Sutter Institute for Medical Research	Sacramento	California
United States	Baptist Clinical Research Institute	Saint Louis	Missouri
United States	Mercy Hospital	Saint Louis	Missouri
United States	Metro Minnesota Community Oncology	Saint Louis Park	Minnesota
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	Texas Oncology	San Antonio	Texas
United States	UCSF Medical Center	San Francisco	California
United States	Sansum Clinic	Santa Barbara	California
United States	Guthrie Clinical Research	Sayre	Pennsylvania
United States	New England Cancer Specialists	Scarborough	Maine
United States	New York Cancer and Blood Specialists	Shirley	New York
United States	Avera Cancer Institute	Sioux Falls	South Dakota
United States	Edward H. Kaplan MD & Associates - Hematology/Oncology of the North Shore	Skokie	Illinois
United States	Ascension Providence Hospital Southfield Cancer Center	Southfield	Michigan
United States	Medical Oncology Associates	Spokane	Washington
United States	Baystate Medical Center Inc.	Springfield	Massachusetts
United States	Springfield Clinic LLP	Springfield	Illinois
United States	Stamford Hospital	Stamford	Connecticut
United States	Stockton Hematology Oncology Medical Group	Stockton	California
United States	Stony Brook Medicine	Stony Brook	New York
United States	Cleveland Clinic Florida, Martin North Hospital	Stuart	Florida
United States	Overlook Medical Center	Summit	New Jersey
United States	SUNY Upstate Medical University	Syracuse	New York
United States	St. Joseph's Hospital	Tampa	Florida
United States	Toledo Clinic Cancer Center	Toledo	Ohio
United States	Greater Baltimore Medical Center	Towson	Maryland
United States	Carle Cancer Center	Urbana	Illinois
United States	Pearlman Cancer Center	Valdosta	Georgia
United States	Reading Hospital and Medical Center	West Reading	Pennsylvania
United States	Clinical Research Alliance	Westbury	New York
United States	White Plains Hospital Physician Associates	White Plains	New York
United States	Cancer Care Associates of York	York	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Gilead Sciences	Alliance Foundation Trials, LLC., NSABP Foundation Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Invasive Disease-free Survival (iDFS)	iDFS is defined as the time from the date of randomization to death from any cause or one of the following events (whichever occurs first): invasive local, regional, or distant recurrence, invasive contralateral breast cancer.	Up to 60 months
Secondary	Overall Survival (OS)	OS is defined as the time from the date of randomization until death due to any cause.	Up to 96 months
Secondary	Distant Disease-free Survival (dDFS)	dDFS is defined as the time from the date of randomization to death from any cause or one of the following events (whichever occurs first): distant recurrence, or second primary invasive cancer.	Up to 60 months
Secondary	Recurrence-free Survival (RFS)	RFS is defined as the time from the date of randomization to death from any cause or one of the following events (whichever occurs first): invasive local, regional, or distant recurrence.	Up to 60 months
Secondary	Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)		First dose date up to 38 months plus 30 days
Secondary	Percentage of Participants Experiencing Laboratory Abnormalities		First dose date up to 38 months plus 30 days
Secondary	Time to Worsening (TTW) of Quality of Life (QoL) Based on Functional Assessment of Cancer Therapy for Breast Cancer (FACT-B) Trial Outcome Index (TOI) Scores	TTW of FACT-B TOI scores will be analyzed for each index, the TTW of FACT-B scores will be measured from the randomization date and to the time the participants first experienced a first score of worsening.	Up to 60 months

External Links

•   Gilead Clinical Trials Website