Clinical trial NCT05633654: 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/GBG 119/NSABP B-63)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Triple Negative Breast Cancer
Keywords: AFT-65
GBG 119
NSABP B-63
OptimICE-RD
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
Collaborators: name: Alliance Foundation Trials, LLC.
name: NSABP Foundation Inc
name: GBG Forschungs GmbH
First posted: 2022-12-01
Enrollment: 1514
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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 endocrine therapy for \> 4 weeks or planned concurrent endocrine therapy while receiving on-study treatment.
* 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.

Primary outcomes:
measure: Invasive Disease-free Survival (iDFS)
timeFrame: Up to 60 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 96 months
measure: Distant Disease-free Survival (dDFS)
timeFrame: Up to 60 months
measure: Recurrence-free Survival (RFS)
timeFrame: Up to 60 months
measure: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
timeFrame: First dose date up to 38 months plus 30 days
measure: Percentage of Participants Experiencing Laboratory Abnormalities
timeFrame: First dose date up to 38 months plus 30 days
measure: 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
timeFrame: Up to 60 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Oncology
state: Alabama
city: Huntsville
country: United States
facility: Clearview Cancer Institute
state: Alabama
city: Glendale
country: United States
facility: Palo Verde Hematology Oncology
state: Arizona
city: Phoenix
country: United States
facility: Mayo Clinic Hospital
state: Arizona
city: Prescott Valley
country: United States
facility: Arizona Oncology Associates
state: Arizona
city: Berkeley
country: United States
facility: Alta Bates Summit Medical Center
state: California
city: Clovis
country: United States
facility: Community Cancer Institute
state: California
city: Downey
country: United States
facility: PIH Health Whittier Hospital
state: California
city: Fountain Valley
country: United States
facility: Compassionate Cancer Care Medical Group - Inc
state: California
city: Los Angeles
country: United States
facility: Los Angeles Cancer Network
state: California
city: Los Angeles
country: United States
facility: USC Norris Comprehensive Cancer Center
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Cancer at Beverly Hills
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: Redlands
country: United States
facility: Emad Ibrahim, MD, INC
state: California
city: Sacramento
country: United States
facility: Sutter Institute for Medical Research
state: California
city: San Francisco
country: United States
facility: UCSF Medical Center
state: California
city: Santa Barbara
country: United States
facility: Sansum Clinic
state: California
city: Stockton
country: United States
facility: Stockton Hematology Oncology Medical Group
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Danbury
country: United States
facility: Norwalk Hospital
state: Connecticut
city: Stamford
country: United States
facility: Stamford Hospital
state: Connecticut
city: Clearwater
country: United States
facility: Morton Plant Hospital - Bay Care
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Jacksonville
country: United States
facility: Cancer Specialists of North Florida
state: Florida
city: Jupiter
country: United States
facility: Jupiter Medical Center
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Comprehensive Cancer Center
state: Florida
city: Orange City
country: United States
facility: Midland Florida Clinical Research Center, L
state: Florida
city: Orlando
country: United States
facility: Orlando Health
state: Florida
city: Palm Bay
country: United States
facility: Cancer Care Centers of Brevard, Inc
state: Florida
city: Pembroke Pines
country: United States
facility: Memorial Healthcare System
state: Florida
city: Pensacola
country: United States
facility: Sacred Heart Medical Oncology Group
state: Florida
city: Plantation
country: United States
facility: Sylvester Comprehensive Cancer Center
state: Florida
city: Stuart
country: United States
facility: Cleveland Clinic Florida, Martin North Hospital
state: Florida
city: Tampa
country: United States
facility: St. Joseph's Hospital
state: Florida
city: Weston
country: United States
facility: Weston Hospital
state: Florida
city: Athens
country: United States
facility: University Cancer & Blood Center, LLC.
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Cancer Institute
state: Georgia
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers, PC
state: Georgia
city: Valdosta
country: United States
facility: Pearlman Cancer Center
state: Georgia
city: Boise
country: United States
facility: St Lukes Mountain States Tumor Institute
state: Idaho
city: Coeur d'Alene
country: United States
facility: Kootenai Health
state: Idaho
city: Chicago
country: United States
facility: Northwestern Medicine
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Illinois
state: Illinois
city: Evanston
country: United States
facility: NorthShore University Healthsystem
state: Illinois
city: Naperville
country: United States
facility: Edward Hospital
state: Illinois
city: River Forest
country: United States
facility: West Suburban Medical Center- River Forest
state: Illinois
city: Skokie
country: United States
facility: Edward H. Kaplan MD & Associates - Hematology/Oncology of the North Shore
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic LLP
state: Illinois
city: Urbana
country: United States
facility: Carle Cancer Center
state: Illinois
city: Indianapolis
country: United States
facility: Franciscan Health Indianapolis
state: Indiana
city: Indianapolis
country: United States
facility: Investigative Clinical Research of Indiana, LLC
state: Indiana
city: Lafayette
country: United States
facility: IU Health Arnett Hospital
state: Indiana
city: Munster
country: United States
facility: Franciscan Health Munster
state: Indiana
city: Cedar Rapids
country: United States
facility: Mercy Medical Center
state: Iowa
city: Des Moines
country: United States
facility: Mission Cancer & Blood - John Stoddard Cancer Center
state: Iowa
city: Fairfield
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Louisville
country: United States
facility: Norton Healthcare, Inc.
state: Kentucky
city: Paducah
country: United States
facility: Mercy Health
state: Kentucky
city: Baton Rouge
country: United States
facility: Mary Bird Perkins Cancer Center
state: Louisiana
city: New Orleans
country: United States
facility: University Medical Center New Orleans
state: Louisiana
city: Scarborough
country: United States
facility: New England Cancer Specialists
state: Maine
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore, Inc.
state: Maryland
city: Baltimore
country: United States
facility: St. Agnes Hospital
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
state: Maryland
city: Baltimore
country: United States
facility: Medstar Franklin Square Medical Center
state: Maryland
city: Bethesda
country: United States
facility: American Oncology Partners of Maryland, PA
state: Maryland
city: Frederick
country: United States
facility: James M Stockman Cancer Institute
state: Maryland
city: Towson
country: United States
facility: Greater Baltimore Medical Center
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Medical Center Inc.
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Worcester
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Grand Rapids
country: United States
facility: Cancer and Hematology Centers of Western Michigan
state: Michigan
city: Grosse Pointe Woods
country: United States
facility: Ascension
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Southfield
country: United States
facility: Ascension Providence Hospital Southfield Cancer Center
state: Michigan
city: Ypsilanti
country: United States
facility: Trinity Health St. Joseph Mercy Ann Arbor
state: Michigan
city: Maplewood
country: United States
facility: Minnesota Oncology Hematology, PA
state: Minnesota
city: Minneapolis
country: United States
facility: Virginia Piper Cancer Center (Allina Health)
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center, Fairview
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Saint Louis Park
country: United States
facility: Metro Minnesota Community Oncology
state: Minnesota
city: Saint Louis
country: United States
facility: Baptist Clinical Research Institute
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Hospital
state: Missouri
city: Hastings
country: United States
facility: Mary Lanning Healthcare - Morrison Cancer Center
state: Nebraska
city: Omaha
country: United States
facility: Oncology Hematology West - Methodist
state: Nebraska
city: Omaha
country: United States
facility: Nebraska Methodist Hospital (change from Chi Health Bergan Mercy)
state: Nebraska
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Reno
country: United States
facility: Cancer Care & Hematology Specialists
state: Nevada
city: East Brunswick
country: United States
facility: Regional Cancer Care Associates LLC
state: New Jersey
city: Flemington
country: United States
facility: Hunterdon Medical Center
state: New Jersey
city: Florham Park
country: United States
facility: Summit Medical Group, P.A.
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Health
state: New Jersey
city: Summit
country: United States
facility: Overlook Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Farmington
country: United States
facility: San Juan Oncology Associates
state: New Mexico
city: Amsterdam
country: United States
facility: New York Oncology Hematology (NYOH)
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: East Syracuse
country: United States
facility: Hematology Oncology Associates of Central New York, PC
state: New York
city: Lake Success
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: Laura and Isaac Perlmutter Cancer Canter
state: New York
city: Rochester
country: United States
facility: Lipson Cancer Institute - Linden Oaks
state: New York
city: Shirley
country: United States
facility: New York Cancer and Blood Specialists
state: New York
city: Stony Brook
country: United States
facility: Stony Brook Medicine
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Westbury
country: United States
facility: Clinical Research Alliance
state: New York
city: White Plains
country: United States
facility: White Plains Hospital Physician Associates
state: New York
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center
state: North Carolina
city: Durham
country: United States
facility: Duke Cancer Institute
state: North Carolina
city: Greensboro
country: United States
facility: Cone Health Medical Group (Moses Cone Health System)
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University Health Medical Center
state: North Carolina
city: Pinehurst
country: United States
facility: FirstHealth Outpatient Cancer Center
state: North Carolina
city: Raleigh
country: United States
facility: UNC Rex Cancer Center
state: North Carolina
city: Rocky Mount
country: United States
facility: UNC Nash Cancer Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist
state: North Carolina
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Oncology Hematology Care, Inc.
state: Ohio
city: Columbus
country: United States
facility: Ohio State University CRS
state: Ohio
city: Columbus
country: United States
facility: Ohio Health Research Institute
state: Ohio
city: Columbus
country: United States
facility: Anita Stewart Oncology Center
state: Ohio
city: Toledo
country: United States
facility: Toledo Clinic Cancer Center
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Bend
country: United States
facility: St. Charles Health System, Inc. DBA St. Charles Medical Center
state: Oregon
city: Corvallis
country: United States
facility: Samaritan Hospital
state: Oregon
city: Eugene
country: United States
facility: Willamette Valley Cancer Institute and Research Center
state: Oregon
city: Medford
country: United States
facility: Asante Rogue Regional Medical Center
state: Oregon
city: Portland
country: United States
facility: Providence Cancer Institute - Oncology Clinical Trials
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Bethlehem
country: United States
facility: Saint Luke's University Hospital
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster General Health
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Abramson Cancer Center
state: Pennsylvania
city: Sayre
country: United States
facility: Guthrie Clinical Research
state: Pennsylvania
city: West Reading
country: United States
facility: Reading Hospital and Medical Center
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Medical Center
state: Pennsylvania
city: York
country: United States
facility: Cancer Care Associates of York
state: Pennsylvania
city: Providence
country: United States
facility: Providence Health
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Center
state: South Carolina
city: Rapid City
country: United States
facility: Monument Health Cancer Care Institute
state: South Dakota
city: Sioux Falls
country: United States
facility: Avera Cancer Institute
state: South Dakota
city: Kingsport
country: United States
facility: Ballad Health Cancer Care - Kingsport
state: Tennessee
city: Knoxville
country: United States
facility: Center for Biomedical Research, LLC
state: Tennessee
city: Knoxville
country: United States
facility: University of Tennessee
state: Tennessee
city: Abilene
country: United States
facility: Hendrick Health System
state: Texas
city: Austin
country: United States
facility: Texas Oncology
state: Texas
city: El Paso
country: United States
facility: Texas Oncology
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Lubbock
country: United States
facility: Joe Arrington Cancer Research and Treatment Center
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center
state: Virginia
city: Wytheville
country: United States
facility: Oncology and Hematology Associates of Southwest Virginia, Inc
state: Virginia
city: Lacey
country: United States
facility: Providence Regional Cancer System
state: Washington
city: Puyallup
country: United States
facility: MultiCare Regional Cancer Center - Tacoma
state: Washington
city: Puyallup
country: United States
facility: Northwest Medical Specialties, PLLC
state: Washington
city: Renton
country: United States
facility: University of Washington
state: Washington
city: Spokane
country: United States
facility: Medical Oncology Associates
state: Washington
city: Morgantown
country: United States
facility: West Virginia University Hospital
state: West Virginia
city: Appleton
country: United States
facility: ThedaCare Regional Cancer Center
state: Wisconsin
city: Franklin
country: United States
facility: Ascension St. Francis Reiman Cancer Center
state: Wisconsin
city: Green Bay
country: United States
facility: HSHS Saint Mary's Hospital Medical Center - Green Bay
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Augsburg
country: Germany
facility: Hämatologie-Onkologie im Zentrum MVZ GmbH
city: Braunschweig
country: Germany
facility: Studien GbR Braunschweig
city: Bremen
country: Germany
facility: Hämato-Onkologische Praxis im Medicum
city: Dortmund
country: Germany
facility: St. Johannes Hospital
city: Esslingen
country: Germany
facility: Klinikum Esslingen
city: Georgsmarienhütte
country: Germany
facility: MVZ II der Niels Stensen Kliniken
city: Kassel
country: Germany
facility: Elisabeth Krankenhaus Brustzentrum
city: Koblenz
country: Germany
facility: InVO - Institut für Versorgungsforschung in der Onkologie GbR / Praxis für Hämatologie und Onkologie
city: Köln
country: Germany
facility: St. Elisabeth Krankenhaus GmbH
city: Mannheim
country: Germany
facility: Universitätsklinikum Mannheim
city: Worms
country: Germany
facility: Klinikum Worms Frauenklinik
city: A Coruña
country: Spain
facility: Medical Oncology Unit. A Coruña University Hospital
city: Barakaldo
country: Spain
facility: Hospital Universitary of Cruces
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Castellón
country: Spain
facility: Consorcio Hospitalario Provincial de Castellón
city: Elche
country: Spain
facility: Hospital General Universitario De Elche
city: Manresa
country: Spain
facility: Althaia Xarxa Assistencial de Manresa
city: Murcia
country: Spain
facility: Hospital Universitario Morales Meseguer
city: Santander
country: Spain
facility: HU Marqués de Valdecilla
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid
city: Zaragoza
country: Spain
facility: Isabel la Catolica nº 1-3
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: