Clinical trial NCT02574455: Trial of Sacituzumab Govitecan in Participants With Refractory/Relapsed Metastatic Triple-Negative Breast Cancer (TNBC)
Official title: An International, Multi-Center, Open-Label, Randomized, Phase III Trial of Sacituzumab Govitecan Versus Treatment of Physician Choice in Patients With Metastatic Triple-Negative Breast Cancer Who Received at Least Two Prior Treatments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2015-10-12
Enrollment: 529
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 primary objective of this study is to compare the efficacy of sacituzumab govitecan to the treatment of physician's choice (TPC) as measured by independently-reviewed Independent Review Committee (IRC) progression-free survival (PFS) in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) previously treated with at least two systemic chemotherapy regimens for unresectable, locally advanced or metastatic disease, and without brain metastasis at baseline.


Eligibility criteria: Key Inclusion Criteria:

* Histologically or cytologically confirmed TNBC based on the most recent analyzed biopsy or other pathology specimen. Triple negative is defined as \<1% expression for estrogen receptor (ER) and progesterone receptor (PR) and negative for human epidermal growth factor receptor 2 (HER2) by in-situ hybridization.
* Refractory to or relapsed after at least two prior standard therapeutic regimens for advanced/metastatic TNBC.
* Prior exposure to a taxane in localized or advanced/metastatic setting.
* Eligible for one of the chemotherapy options listed as TPC (eribulin, capecitabine, gemcitabine, or vinorelbine) as per investigator assessment.
* Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.
* Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Bone-only disease is not permitted.
* At least 2 weeks beyond prior anti-cancer treatment (chemotherapy, endocrine therapy, radiotherapy, and/or major surgery), and recovered from all acute toxicities to Grade 1 or less (except alopecia and peripheral neuropathy).
* At least 2 weeks beyond high dose systemic corticosteroids (however, low dose corticosteroids \< 20 mg prednisone or equivalent daily are permitted provided the dose is stable for 4 weeks).
* Adequate hematology without ongoing transfusional support (hemoglobin \> 9 g/dL, absolute neutrophil count (ANC) \> 1,500 per mm\^3, platelets \> 100,000 per mm\^3).
* Adequate renal and hepatic function (creatinine clearance \[CrCL\] \> 60 mL/min, bilirubin ≤ 1.5 institutional upper limit of normal \[IULN\], aspartate aminotransferase \[AST\] and alanine aminotransferase \[ALT\] ≤ 2.5 x IULN or ≤ 5 x IULN if known liver metastases and serum albumin ≥3 g/dL).
* Recovered from all toxicities to Grade 1 or less by National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) v4.03 (except alopecia or peripheral neuropathy that may be Grade 2 or less) at the time of randomization. Participants with Grade 2 neuropathy are eligible but may not receive vinorelbine as TPC.
* Participants with treated, non-progressive brain metastases, off high-dose steroids (\>20 mg prednisone or equivalent) for at least 4 weeks can be enrolled in the trial.

Key Exclusion Criteria:

* Women who are pregnant or lactating.
* Women of childbearing potential or fertile men unwilling to use effective contraception during study and up to three months after treatment discontinuation in women of child-bearing potential and six months in males post last study drug.
* Participants with Gilbert's disease.
* Participants with non-melanoma skin cancer or carcinoma in situ of the cervix are eligible, while participants with other prior malignancies must have had at least a 3-year disease-free interval.
* Participants known to be human immunodeficiency (HIV) positive, hepatitis B positive, or hepatitis C positive.
* Infection requiring antibiotic use within one week of randomization.
* Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.

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

Primary outcomes:
measure: Progression-Free Survival (PFS) by Independent Review Committee (IRC) Assessment in Brain Metastasis Negative (BM-ve) Population
timeFrame: From randomization until objective tumor progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)
Secondary outcomes:
measure: Progression-Free Survival (PFS) by IRC Assessment in the ITT Population
timeFrame: From randomization until objective tumor progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)
measure: Overall Survival (OS) in BM-ve Population
timeFrame: From the randomization to death from any cause (maximum follow-up duration: 30.8 months)
measure: Overall Survival (OS) in ITT Population
timeFrame: From the randomization to death from any cause (maximum follow-up duration: 30.8 months)
measure: Objective Response Rate (ORR) by IRC and Investigator Assessment in BM-ve Population
timeFrame: From randomization to the date of progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)
measure: Time to Objective Response by the Investigator Assessment in BM-ve Population
timeFrame: From randomization to the first recorded objective response (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)
measure: Time to Objective Response by the IRC Assessment in BM-ve Population
timeFrame: From randomization to the first recorded objective response (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)
measure: Duration of Response (DOR) by IRC and Investigator Assessment in BM-ve Population
timeFrame: From the first date of documented response of CR or PR to the date of progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)
measure: Time to Progression (TTP) by Investigator Assessment in BM-ve Population
timeFrame: From randomization until disease progression (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)
measure: Time to Progression (TTP) by IRC Assessment in BM-ve Population
timeFrame: From randomization until disease progression (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)
measure: Clinical Benefit Rate (CBR) by IRC and Investigator Assessment in BM-ve Population
timeFrame: From randomization to the date of progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)
measure: Percentage of Participants Experiencing Any Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation of Study Drug
timeFrame: First dose date up to last follow-up (maximum up to 30.8 months)
measure: Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ-C30) Score
timeFrame: Baseline; End of Treatment (EOT) (up to 29.6 months)
measure: Percentage of Participants Experiencing the Worst Laboratory Abnormalities Grade 3 or 4 Post-Baseline
timeFrame: First dose date up to last follow-up (maximum up to 30.8 months)
Other outcomes:
Locations:
city: Daphne
country: United States
facility: Southern Cancer Center, 29653 Anchor Cross Blvd
state: Alabama
city: Mobile
country: United States
facility: Souther Cancer Center, 3719 Dauphin St., 5 Floor
state: Alabama
city: Mobile
country: United States
facility: Southern Cancer Center, 3 Mobile Infirmary Circle
state: Alabama
city: Mobile
country: United States
facility: Southern Cancer Center, 6701 Airport Blvd., Bldg B, Terace Level
state: Alabama
city: Phoenix
country: United States
facility: Mayo Clinic Hospital
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic Hospital
state: Arizona
city: Alhambra
country: United States
facility: UCLA Jonsson Comprehensive Cancer Center, 1411 S. Garfield Ave Suite 200
state: California
city: Burbank
country: United States
facility: UCLA Jonsson Comprehensive Cancer Center, 201. S. Buena Vista St Suite 200
state: California
city: Laguna Hills
country: United States
facility: UCLA Jonsson Comprehensive Cancer Center
state: California
city: Los Angeles
country: United States
facility: UCLA Jonsson Comprehensive Cancer Center, 200 UCLA Medical Plaza
state: California
city: Pasadena
country: United States
facility: UCLA Jonsson Comprehensive Cancer Center, 625 South Fair Oaks Avenue Suite 320
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco (UCSF) - Innovation, Technology & Alliances, 1600 Divisadero Street
state: California
city: Santa Monica
country: United States
facility: UCLA Jonsson Comprehensive Cancer Center, 2020 Santa Monica Boulevard
state: California
city: Aurora
country: United States
facility: Rocky Mountain Cancer Centers, 1700 South Potomac Street
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Hospital - Anschutz Cancer Pavilion, 1665 Aurora Court
state: Colorado
city: Boulder
country: United States
facility: Rocky Mountain Cancer Centers, 4715 Arapahoe Ave
state: Colorado
city: Colorado Springs
country: United States
facility: Rocky Mountain Cancer Centers, 2312 N. Nevada Avenue, Suite 400
state: Colorado
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers, 1800 Williams St.
state: Colorado
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers, 4700 E. Hale Parkway, Suite 400
state: Colorado
city: Englewood
country: United States
facility: Rocky Mountain Cancer Centers, 499 E Hampden Ave Suite 450
state: Colorado
city: Lakewood
country: United States
facility: Rocky Mountain Cancer Centers, 11750 West 2nd Place, Suite 1-100
state: Colorado
city: Littleton
country: United States
facility: Rocky Mountain Cancer Centers, 22 West Dry Creek Circle
state: Colorado
city: Lone Tree
country: United States
facility: Rocky Mountain Cancer Centers, 10103 Ridge Gate Parkway, Suite G-01
state: Colorado
city: Longmont
country: United States
facility: Rocky Mountain Cancer Centers, 2030 W Mountain View Avenue, Ste. 210
state: Colorado
city: Parker
country: United States
facility: Rocky Mountain Cancer Centers, 9397 Crown Crest Blvd., Suite 421
state: Colorado
city: Pueblo
country: United States
facility: Rocky Mountain Cancer Centers, 3676 Parker Blvd., Suite 350
state: Colorado
city: Thornton
country: United States
facility: Rocky Mountain Cancer Centers, 8820 Huron Street
state: Colorado
city: New Haven
country: United States
facility: Yale School Of Medicine
state: Connecticut
city: Norwalk
country: United States
facility: Norwalk Hospital, 34 Maple Street
state: Connecticut
city: Washington
country: United States
facility: Georgetown Lombardi Comprehensive Cancer Center
state: District of Columbia
city: Altamonte Springs
country: United States
facility: Florida Cancer Specialists & Research Institute, 601 E. Altamonte Drive
state: Florida
city: Bonita Springs
country: United States
facility: Florida Cancer Specialist
state: Florida
city: Bradenton
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Brandon
country: United States
facility: Florida Cancer Specialists & Research Institute, 403 S. King Ave
state: Florida
city: Cape Coral
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Clearwater
country: United States
facility: Florida Cancer Specialists & Research Institute, 3280 McMullen Booth road
state: Florida
city: Coral Gables
country: United States
facility: Sylvester Comprehensive Cancer Center
state: Florida
city: Daytona Beach
country: United States
facility: Florida Cancer Specialists & Research Institute, 224 Memorial medical Parway
state: Florida
city: Deerfield Beach
country: United States
facility: Sylvester Comprehensive Cancer Center
state: Florida
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Gainesville
country: United States
facility: Florida Cancer Specialists & Research Institute, 6420 W Newberry Road Est Wing
state: Florida
city: Largo
country: United States
facility: Florida Cancer Specialists & Research Institute, 100 Highland Avenue
state: Florida
city: Lecanto
country: United States
facility: Florida Cancer Specialists & Research Institute, 521 N. Lecanto Highway
state: Florida
city: Miami
country: United States
facility: Sylvester Comprehensive Cancer Center
state: Florida
city: Miami
country: United States
facility: Baptist Health Medical Group Oncology, LLC
state: Florida
city: Naples
country: United States
facility: Florida Cancer Specialists
state: Florida
city: New Port Richey
country: United States
facility: Florida Cancer Specialists & Research Institute, 8763 River Crossing Blvd
state: Florida
city: Ocala
country: United States
facility: Florida Cancer Specialists & Research Institute, 1630 SE 18th ST
state: Florida
city: Orange City
country: United States
facility: Florida Cancer Specialists & Research Institute, 765 Image Way
state: Florida
city: Orlando
country: United States
facility: Orlando Regional Medical Center
state: Florida
city: Orlando
country: United States
facility: Florida Cancer Specialists & Research Institute, 70 W Gore Street
state: Florida
city: Ormond Beach
country: United States
facility: Florida Cancer Specialists & Research Institute - 325 Clyde Morris
state: Florida
city: Plantation
country: United States
facility: Sylvester Comprehensive Cancer Center
state: Florida
city: Port Charlotte
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists & Research Institute, 1201 Fifth Avenue North
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists & Research Institute, 560 Jackson St
state: Florida
city: Sarasota
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Spring Hill
country: United States
facility: Florida Cancer Specialists & Research Institute, 7154 Medical Center Drive
state: Florida
city: Tampa
country: United States
facility: Florida Cancer Specialists & Research Institute, 3402 W Dr. Martin Luther King Jr Boulevard
state: Florida
city: Tavares
country: United States
facility: Florida Cancer Specialists & Research Institute, 4100 Waterman Way
state: Florida
city: The Villages
country: United States
facility: Florida Cancer Specialists & Research Institute, 1400 US highway 441 N
state: Florida
city: Venice
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Venice
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Vero Beach
country: United States
facility: Florida Cancer Specialists & Research Institute - 3730 7th Terrace
state: Florida
city: Wellington
country: United States
facility: Florida Cancer Specialists & Research Institute, 1037 State Road 7 Bldg B
state: Florida
city: West Palm Beach
country: United States
facility: Florida Cancer Specialists & Research Institute1309 N Flagler Dr
state: Florida
city: Winter Park
country: United States
facility: Florida Cancer Specialists & Research Institute, 2100 Glenwood Drive
state: Florida
city: Alpharetta
country: United States
facility: Atlanta Cancer Center - Alpharetta
state: Georgia
city: Athens
country: United States
facility: University Cancer & Blood Center, 3320 Old Jefferson Rd
state: Georgia
city: Atlanta
country: United States
facility: GCS/Annex
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Cancer Care - Atlanta
state: Georgia
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: Canton
country: United States
facility: GCS/Canton
state: Georgia
city: Conyers
country: United States
facility: Atlanta Cancer Care - Conyers
state: Georgia
city: Cumming
country: United States
facility: Atlanta Cancer Care - Cumming
state: Georgia
city: Decatur
country: United States
facility: Atlanta Cancer Care - Decatur
state: Georgia
city: Decatur
country: United States
facility: GCS/Stemmer
state: Georgia
city: Jonesboro
country: United States
facility: Atlanta Cancer Care - Stockbridge
state: Georgia
city: Macon
country: United States
facility: GCS/Macon
state: Georgia
city: Marietta
country: United States
facility: GCS/Kennestone
state: Georgia
city: Sandy Springs
country: United States
facility: GCS/Northside
state: Georgia
city: Arlington Heights
country: United States
facility: Illinois Cancer Specialists
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center 5841 S. Maryland Ave
state: Illinois
city: New Lenox
country: United States
facility: University of Chicago Comprehensive Cancer Center at Silver Cross Hospital 1900 Silver Cross Blvd
state: Illinois
city: Niles
country: United States
facility: Illinois Cancer Specialists
state: Illinois
city: Orland Park
country: United States
facility: Orland Park - UCMC Center for Advanced Care 14290 South LaGrange Rd
state: Illinois
city: Overland Park
country: United States
facility: MidAmerica Division Inc. c/o Menorah Medical Center
state: Kansas
city: Westwood
country: United States
facility: University of Kansas Cancer Center - The Richard and Annette Bloch Cancer Care Pavilion
state: Kansas
city: Bethesda
country: United States
facility: Maryland Oncology Hematology
state: Maryland
city: Brandywine
country: United States
facility: Maryland Oncology Hematology
state: Maryland
city: Clinton
country: United States
facility: Maryland Oncology Hematology
state: Maryland
city: Columbia
country: United States
facility: Maryland Oncology Hematology
state: Maryland
city: Rockville
country: United States
facility: Maryland Oncology Hematology
state: Maryland
city: Silver Spring
country: United States
facility: Maryland Oncology Hematology
state: Maryland
city: Silver Spring
country: United States
facility: Maryland Oncology Hematology
state: Maryland
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center (BIDMC)
state: Massachusetts
city: Danvers
country: United States
facility: Mass General - North Shore Cancer Center ( NSCC )
state: Massachusetts
city: Coon Rapids
country: United States
facility: Mercy Hospital
state: Minnesota
city: Coon Rapids
country: United States
facility: Minnesota Oncology Hematology P.A.
state: Minnesota
city: Coon Rapids
country: United States
facility: Suburban Imaging Northwest
state: Minnesota
city: Coon Rapids
country: United States
facility: Suburban Imaging
state: Minnesota
city: Fridley
country: United States
facility: Mercy Hospital - Unity Campus AHL
state: Minnesota
city: Fridley
country: United States
facility: Minnesota Oncology Hematology P.A.
state: Minnesota
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology P.A.
state: Minnesota
city: Minneapolis
country: United States
facility: Abbot Northwestern Hospital
state: Minnesota
city: Minneapolis
country: United States
facility: Virginia G. Piper Cancer Center at HonorHealth
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic - 200 First Street SW
state: Minnesota
city: Creve Coeur
country: United States
facility: Washington University School of Medicine in St. Louis
state: Missouri
city: Independence
country: United States
facility: MidAmerica Division Inc. c/o Menorah Medical Center
state: Missouri
city: Kansas City
country: United States
facility: Research Medical Center
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine in St. Louis
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine in St. Louis
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine in St. Louis
state: Missouri
city: Omaha
country: United States
facility: Nebraska Cancer Specialists - Midwest Cancer Center - Papillion
state: Nebraska
city: Omaha
country: United States
facility: Nebraska Cancer Specialists - Midwest Cancer Center - Paillion
state: Nebraska
city: Papillion
country: United States
facility: Nebraska Cancer Specialists- Midwest Cancer Center- Papillion
state: Nebraska
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Albany
country: United States
facility: New York Oncology Hematology, P.C.
state: New York
city: Clifton Park
country: United States
facility: New York Oncology Hematology, P.C.
state: New York
city: East Setauket
country: United States
facility: North Shore Hematology Oncology Associates., PC, 235 North Belle Mead Road
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Patchogue
country: United States
facility: North Shore Hematology Oncology Associates., PC, 285 Sills Road Building 16
state: New York
city: Chapel Hill
country: United States
facility: UNC Health Care System
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center, 460 W 10th Ave
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center, 1145 Olentangy River Road
state: Ohio
city: Portland
country: United States
facility: Providence Medical Group
state: Oregon
city: Greensburg
country: United States
facility: UPMC Hillman Cancer Center Mountainview Arnold Palmer Pavilion
state: Pennsylvania
city: Monroeville
country: United States
facility: UPMC Hillman Cancer Center UPMC East
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center Upper Saint Clair
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny-Singer Research Institute, 320 East North Avenue
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Magee-Womens Hospital of UPMC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center UPMC Passavant
state: Pennsylvania
city: Chattanooga
country: United States
facility: Tennessee Oncology - Chattanooga Oncology & Hematology Associates
state: Tennessee
city: Chattanooga
country: United States
facility: Tennesee Oncology - PLLC
state: Tennessee
city: Cleveland
country: United States
facility: Tenesse Oncology - PLLC
state: Tennessee
city: Dickson
country: United States
facility: Tennessee Oncology, LLC
state: Tennessee
city: Franklin
country: United States
facility: Tennessee Ocology, LLC
state: Tennessee
city: Gallatin
country: United States
facility: Tennessee Oncology, LLC
state: Tennessee
city: Germantown
country: United States
facility: West Cancer Center, 7945 Wolf River Blvd
state: Tennessee
city: Hermitage
country: United States
facility: Tennessee Oncology, LLC
state: Tennessee
city: Lebanon
country: United States
facility: Tennessee Oncology, LLC
state: Tennessee
city: Murfreesboro
country: United States
facility: Tennessee Oncology, LLC
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Cancer Institute/Tennessee Oncology
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, LLC
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Breast Cancer Center at One Hundred Oaks 719 Thompson Lane, Suite 25000
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Ocology, LLC
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, LLC
state: Tennessee
city: Nashville
country: United States
facility: Tenessee Oncology
state: Tennessee
city: Nashville
country: United States
facility: Henry-Joyce Cancer Clinic 1301 Medical Center Drive 1903 The Vanderbilt Clinic Nashville, TN 37232
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
city: Shelbyville
country: United States
facility: Tennessee Oncology, LLC
state: Tennessee
city: Arlington
country: United States
facility: Center for Cancer and Blood Disorders
state: Texas
city: Burleson
country: United States
facility: Center for Cancer and Blood Disorders
state: Texas
city: Dallas
country: United States
facility: Texas Oncology- Medical City Dallas Building D
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Baylor Charles A. Sammons Cancer Center
state: Texas
city: Denton
country: United States
facility: Texas Oncology
state: Texas
city: Fort Worth
country: United States
facility: Center for Cancer and Blood Disorders
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital - 6565 Fannin St
state: Texas
city: Longview
country: United States
facility: Texas Oncology-Longview Cancer Center
state: Texas
city: Plano
country: United States
facility: Texas Oncology
state: Texas
city: Tyler
country: United States
facility: US Oncology
state: Texas
city: Weatherford
country: United States
facility: Center for Cancer and Blood Disorders
state: Texas
city: Alexandria
country: United States
facility: Virginia Cancer Specialists, PC
state: Virginia
city: Arlington
country: United States
facility: Virginia Cancer Specialists, PC
state: Virginia
city: Blacksburg
country: United States
facility: Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
state: Virginia
city: Chesapeake
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Fairfax
country: United States
facility: Virginia Cancer Specialists, PC
state: Virginia
city: Gainesville
country: United States
facility: Virginia Cancer Specialists, PC
state: Virginia
city: Hampton
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Leesburg
country: United States
facility: Virginia Cancer Specialists, PC
state: Virginia
city: Low Moor
country: United States
facility: Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
state: Virginia
city: Newport News
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates, P.C.
state: Virginia
city: Roanoke
country: United States
facility: Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
state: Virginia
city: Salem
country: United States
facility: Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
state: Virginia
city: Virginia Beach
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Woodbridge
country: United States
facility: Virginia Cancer Specialists, PC
state: Virginia
city: Wytheville
country: United States
facility: Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
state: Virginia
city: Edmonds
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Issaquah
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Brussels
country: Belgium
facility: Universitair Zlekenhuis Brussel
city: Bruxelles
country: Belgium
facility: Institut Jules Bordet
city: Leuven
country: Belgium
facility: UZ Leuven
city: Namur
country: Belgium
facility: Clinique et Maternite Sainte-Elisabeth
city: Edmonton
country: Canada
facility: Cross Cancer Institute, 11560 University Avenue
state: Alberta
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Montréal
country: Canada
facility: Jewish General Hospital, 3755 Côte-Sainte-Catherine
state: Quebec
city: Québec
country: Canada
facility: Jewish General Hospital, 3755 Côte-Sainte-Catherine
state: Quebec
city: Angers
country: France
facility: Centre de Lutte Contre le Cancer - Institut de Cancerologie de l'Ouest - Paul Papin
city: Besançon
country: France
facility: CHU Besançon - Hôpital Jean Minjoz
city: Montpellier
country: France
facility: Institut Régional du Cancer de Montpellier
city: Paris
country: France
facility: Institut Curie
city: Rennes Cedex
country: France
facility: Centre Eugène Marquis
city: Saint-Cloud
country: France
facility: Florence Lerebours
city: Saint-Herblain
country: France
facility: CHU de Nantes - Hôpital Nord Laennec
city: Toulouse
country: France
facility: Institut Claudius Regaud
city: Villejuif
country: France
facility: Gustave Roussy
city: Frankfurt
country: Germany
facility: Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus
city: Freiburg im Breisgau
country: Germany
facility: Praxis für interdisziplinäre Onkologie & Hämatologie GbR
city: Hamburg
country: Germany
facility: Facharztzentrum Eppendorf
city: Koblenz
country: Germany
facility: Institut für Versorgungsforschung in der Onkologie
city: Velbert
country: Germany
facility: Praxis für Hämatologie und Internistische Onkologie
city: A Coruña
country: Spain
facility: Hospital Teresa Herrera, As Xubias, 84
city: Barcelona
country: Spain
facility: Hospital Quirón Barcelona, Plaza Alfonso Comín 5
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau, Carrer del Mas Casanovas, 90
city: Hospitalet de Llobregat
country: Spain
facility: Institut Catala d'Oncologia Hospitalet, Avenida Gran Via 199-203
city: Lleida
country: Spain
facility: Hospital Universitari Arnau de Vilanova de Lleida
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Santiago De Compostela
country: Spain
facility: Complexo Hospitalario Universitario de Santiago (CHUS) - Hospital Clinco Universaitario
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Colchester
country: United Kingdom
facility: Colchester Hospital University NHS Foundation Trust - Colchester General Hospital, Turner Road
state: ESS
city: Coventry
country: United Kingdom
facility: The Arden Cancer Centre- University Hospital Coventry
city: Durham
country: United Kingdom
facility: County Durham and Darlington NHS Foundation Trust - University Hospital of North Durham
city: Guildford
country: United Kingdom
facility: The Royal Surrey County Hospital NHS Foundation Trust
city: Hereford
country: United Kingdom
facility: The County Hospital, Wye Valley NHS Trust
city: London
country: United Kingdom
facility: The Royal Free London NHS Foundation Trust - The Royal Free Hospital, Pond Street Oncology & Haematology Clinical Trials Unit Dept. of Academic Oncology
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust - City Hospital
city: Plymouth
country: United Kingdom
facility: Plymouth Hospitals NHS Trust - Derriford Hospital
city: Taunton
country: United Kingdom
facility: Taunton and Somerset NHS Foundation Trust - Musgrove Park Hospital, Musgrove Park Hospital
city: Wakefield
country: United Kingdom
facility: The Mid Yorkshire Hospitals NHS Trust - Pinderfields Hospital
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
citation: Bardia A, Mayer IA, Vahdat LT, Tolaney SM, Isakoff SJ, Diamond JR, O'Shaughnessy J, Moroose RL, Santin AD, Abramson VG, Shah NC, Rugo HS, Goldenberg DM, Sweidan AM, Iannone R, Washkowitz S, Sharkey RM, Wegener WA, Kalinsky K. Sacituzumab Govitecan-hziy in Refractory Metastatic Triple-Negative Breast Cancer. N Engl J Med. 2019 Feb 21;380(8):741-751. doi: 10.1056/NEJMoa1814213.
citation: Huvitz SA, Tolaney SM, Punie K, et al. 2020 SABCS GS3-06. Biomarker evaluation in the phase 3 ASCENT study of sacituzumab govitecan versus chemotherapy in patients with metastatic triple-negative breast cancer. San Antonio Breast Cancer Symposium; December 8-11, 2020; San Antonio, TX.
citation: Dieras V, Weaver R, Tolaney SM, et al. 2020 SABCS PD13-07. Subgroup analysis of patients with brain metastases from the phase 3 ASCENT study of sacituzumab govitecan versus chemotherapy in metastatic triple-negative breast cancer. San Antonio Breast Cancer Symposium; December 8-11, 2020; San Antonio, TX.
citation: Rugo HS, Tolaney SM, Loirat D, et al. 2020 SABCS PS11-09. Impact of UGT1A1 status on the safety profile of sacituzumab govitecan in the phase 3 ASCENT study in patients with metastatic triple-negative breast cancer. San Antonio Breast Cancer Symposium; December 8-11, 2020; San Antonio, TX.
citation: Bardia A, Tolaney SM, Loirat D, et al. ASCENT: A randomized phase III study of sacituzumab govitecan (SG) vs treatment of physician's choice (TPC) in patients (pts) with previously treated metastatic triple-negative breast cancer (mTNBC). Annals of Oncology (2020) 31 (suppl_4): S1142-S1215. 10.1016/annonc/annonc325
citation: Bardia A, Rugo RS, Horne H, et al. A phase III, randomized trial of sacituzumab govitecan (IMMU-132) vs treatment of physician choice (TPC) for metastatic triple-negative breast cancer (mTNBC). Cancer Res. 2018;78 (4 Supplement): OT2-07-05
citation: O'Shaughnessy J, Brufsky A, Rugo HS, Tolaney SM, Punie K, Sardesai S, Hamilton E, Loirat D, Traina T, Leon-Ferre R, Hurvitz SA, Kalinsky K, Bardia A, Henry S, Mayer I, Zhu Y, Phan S, Cortes J. Analysis of patients without and with an initial triple-negative breast cancer diagnosis in the phase 3 randomized ASCENT study of sacituzumab govitecan in metastatic triple-negative breast cancer. Breast Cancer Res Treat. 2022 Sep;195(2):127-139. doi: 10.1007/s10549-022-06602-7. Epub 2022 May 11.
citation: Bardia A, Hurvitz SA, Rugo HS, Brufsky A, Cortes J, Loibl S, Piccart M, Cowden J, Spears P, Carey LA. A plain language summary of the ASCENT study: Sacituzumab Govitecan for metastatic triple-negative breast cancer. Future Oncol. 2021 Oct 1;17(30):3911-3924. doi: 10.2217/fon-2021-0868. Epub 2021 Sep 1.
citation: Bardia A, Hurvitz SA, Tolaney SM, Loirat D, Punie K, Oliveira M, Brufsky A, Sardesai SD, Kalinsky K, Zelnak AB, Weaver R, Traina T, Dalenc F, Aftimos P, Lynce F, Diab S, Cortes J, O'Shaughnessy J, Dieras V, Ferrario C, Schmid P, Carey LA, Gianni L, Piccart MJ, Loibl S, Goldenberg DM, Hong Q, Olivo MS, Itri LM, Rugo HS; ASCENT Clinical Trial Investigators. Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer. N Engl J Med. 2021 Apr 22;384(16):1529-1541. doi: 10.1056/NEJMoa2028485.
citation: McCann KE, Hurvitz SA. Innovations in targeted therapies for triple negative breast cancer. Curr Opin Obstet Gynecol. 2021 Feb 1;33(1):34-47. doi: 10.1097/GCO.0000000000000671.
citation: Seligson JM, Patron AM, Berger MJ, Harvey RD, Seligson ND. Sacituzumab Govitecan-hziy: An Antibody-Drug Conjugate for the Treatment of Refractory, Metastatic, Triple-Negative Breast Cancer. Ann Pharmacother. 2021 Jul;55(7):921-931. doi: 10.1177/1060028020966548. Epub 2020 Oct 17.