Trial of Sacituzumab Govitecan in Participants With Refractory/Relapsed Metastatic Triple-Negative Breast Cancer (TNBC)
ASCENT
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
2 other identifiers
interventional
529
7 countries
230
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 breast-cancer
Started Nov 2017
Shorter than P25 for phase_3 breast-cancer
230 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2015
CompletedFirst Posted
Study publicly available on registry
October 12, 2015
CompletedStudy Start
First participant enrolled
November 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 8, 2020
CompletedResults Posted
Study results publicly available
April 30, 2021
CompletedJune 15, 2022
May 1, 2022
2.4 years
October 8, 2015
March 11, 2021
May 26, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS) by Independent Review Committee (IRC) Assessment in Brain Metastasis Negative (BM-ve) Population
PFS was defined as the time from randomization until objective tumor progression by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death, whichever came first. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (greater than or equal to \[≥\] 20%) in the sum of the target lesions or the appearance of new non-target lesions. PFS was estimated using Kaplan-Meier estimate.
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 (13)
Progression-Free Survival (PFS) by IRC Assessment in the ITT Population
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)
Overall Survival (OS) in BM-ve Population
From the randomization to death from any cause (maximum follow-up duration: 30.8 months)
Overall Survival (OS) in ITT Population
From the randomization to death from any cause (maximum follow-up duration: 30.8 months)
Objective Response Rate (ORR) by IRC and Investigator Assessment in BM-ve Population
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)
Time to Objective Response by the Investigator Assessment in BM-ve Population
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)
- +8 more secondary outcomes
Study Arms (2)
Sacituzumab Govitecan
EXPERIMENTALParticipants will receive sacituzumab govitecan on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Participants will continue treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable adverse events (AEs).
Treatment of Physician's Choice (TPC)
ACTIVE COMPARATORParticipants will receive TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that is selected by the investigator before participant randomization. Participants will continue treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.
Interventions
10 mg/kg administered as a slow intravenous (IV) infusion either by gravity or with an infusion pump. Infusion rate for the first 15 minutes will start with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour.
Administered IV over 2 to 5 minutes at a dose 1.4 mg/m\^2 at North American sites and 1.23 mg/m\^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses will be administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m\^2 and 0.67 mg/m\^2 for North American and European sites, respectively).
1000 to 1250 mg/m\^2 will be administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months.
800 to 1200 mg/m\^2 will be administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months.
25 mg/m\^2 will be administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine will not be allowed as TPC for any participant with Grade 2 neuropathy.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (230)
Southern Cancer Center, 29653 Anchor Cross Blvd
Daphne, Alabama, 36526, United States
Souther Cancer Center, 3719 Dauphin St., 5 Floor
Mobile, Alabama, 36608, United States
Southern Cancer Center, 3 Mobile Infirmary Circle
Mobile, Alabama, 36608, United States
Southern Cancer Center, 6701 Airport Blvd., Bldg B, Terace Level
Mobile, Alabama, 36608, United States
Mayo Clinic Hospital
Phoenix, Arizona, 85054, United States
Mayo Clinic Hospital
Scottsdale, Arizona, 85259, United States
UCLA Jonsson Comprehensive Cancer Center, 1411 S. Garfield Ave Suite 200
Alhambra, California, 91801, United States
UCLA Jonsson Comprehensive Cancer Center, 201. S. Buena Vista St Suite 200
Burbank, California, 91505, United States
UCLA Jonsson Comprehensive Cancer Center
Laguna Hills, California, 92653, United States
UCLA Jonsson Comprehensive Cancer Center, 200 UCLA Medical Plaza
Los Angeles, California, 90095, United States
UCLA Jonsson Comprehensive Cancer Center, 625 South Fair Oaks Avenue Suite 320
Pasadena, California, 91105, United States
University of California, San Francisco (UCSF) - Innovation, Technology & Alliances, 1600 Divisadero Street
San Francisco, California, 94115, United States
UCLA Jonsson Comprehensive Cancer Center, 2020 Santa Monica Boulevard
Santa Monica, California, 94115, United States
Rocky Mountain Cancer Centers, 1700 South Potomac Street
Aurora, Colorado, 80012-5405, United States
University of Colorado Hospital - Anschutz Cancer Pavilion, 1665 Aurora Court
Aurora, Colorado, 80045, United States
Rocky Mountain Cancer Centers, 4715 Arapahoe Ave
Boulder, Colorado, 80303, United States
Rocky Mountain Cancer Centers, 2312 N. Nevada Avenue, Suite 400
Colorado Springs, Colorado, 80907, United States
Rocky Mountain Cancer Centers, 1800 Williams St.
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers, 4700 E. Hale Parkway, Suite 400
Denver, Colorado, 80220, United States
Rocky Mountain Cancer Centers, 499 E Hampden Ave Suite 450
Englewood, Colorado, 80113, United States
Rocky Mountain Cancer Centers, 11750 West 2nd Place, Suite 1-100
Lakewood, Colorado, 80228, United States
Rocky Mountain Cancer Centers, 22 West Dry Creek Circle
Littleton, Colorado, 80120, United States
Rocky Mountain Cancer Centers, 10103 Ridge Gate Parkway, Suite G-01
Lone Tree, Colorado, 80124, United States
Rocky Mountain Cancer Centers, 2030 W Mountain View Avenue, Ste. 210
Longmont, Colorado, 80501, United States
Rocky Mountain Cancer Centers, 9397 Crown Crest Blvd., Suite 421
Parker, Colorado, 80138, United States
Rocky Mountain Cancer Centers, 3676 Parker Blvd., Suite 350
Pueblo, Colorado, 81008, United States
Rocky Mountain Cancer Centers, 8820 Huron Street
Thornton, Colorado, 80260, United States
Yale School Of Medicine
New Haven, Connecticut, 06510-3206, United States
Norwalk Hospital, 34 Maple Street
Norwalk, Connecticut, 06856, United States
Georgetown Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 20007, United States
Florida Cancer Specialists & Research Institute, 601 E. Altamonte Drive
Altamonte Springs, Florida, 32701, United States
Florida Cancer Specialist
Bonita Springs, Florida, 34135, United States
Florida Cancer Specialists
Bradenton, Florida, 34209, United States
Florida Cancer Specialists & Research Institute, 403 S. King Ave
Brandon, Florida, 33511, United States
Florida Cancer Specialists
Cape Coral, Florida, 33914, United States
Florida Cancer Specialists & Research Institute, 3280 McMullen Booth road
Clearwater, Florida, 33761, United States
Sylvester Comprehensive Cancer Center
Coral Gables, Florida, 33146, United States
Florida Cancer Specialists & Research Institute, 224 Memorial medical Parway
Daytona Beach, Florida, 32117, United States
Sylvester Comprehensive Cancer Center
Deerfield Beach, Florida, 33442, United States
Florida Cancer Specialists
Fort Myers, Florida, 33905, United States
Florida Cancer Specialists & Research Institute, 6420 W Newberry Road Est Wing
Gainesville, Florida, 32605, United States
Florida Cancer Specialists & Research Institute, 100 Highland Avenue
Largo, Florida, 33770, United States
Florida Cancer Specialists & Research Institute, 521 N. Lecanto Highway
Lecanto, Florida, 34461, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
Baptist Health Medical Group Oncology, LLC
Miami, Florida, 33176, United States
Florida Cancer Specialists
Naples, Florida, 34102, United States
Florida Cancer Specialists & Research Institute, 8763 River Crossing Blvd
New Port Richey, Florida, 34655, United States
Florida Cancer Specialists & Research Institute, 1630 SE 18th ST
Ocala, Florida, 34471, United States
Florida Cancer Specialists & Research Institute, 765 Image Way
Orange City, Florida, 32763, United States
Orlando Regional Medical Center
Orlando, Florida, 32806-2008, United States
Florida Cancer Specialists & Research Institute, 70 W Gore Street
Orlando, Florida, 32806, United States
Florida Cancer Specialists & Research Institute - 325 Clyde Morris
Ormond Beach, Florida, 32774, United States
Sylvester Comprehensive Cancer Center
Plantation, Florida, 33324, United States
Florida Cancer Specialists
Port Charlotte, Florida, 33980, United States
Florida Cancer Specialists
Sarasota, Florida, 34236, United States
Florida Cancer Specialists & Research Institute, 7154 Medical Center Drive
Spring Hill, Florida, 34608, United States
Florida Cancer Specialists & Research Institute, 1201 Fifth Avenue North
St. Petersburg, Florida, 33705-1449, United States
Florida Cancer Specialists & Research Institute, 560 Jackson St
St. Petersburg, Florida, 33705, United States
Florida Cancer Specialists & Research Institute, 3402 W Dr. Martin Luther King Jr Boulevard
Tampa, Florida, 33607, United States
Florida Cancer Specialists & Research Institute, 4100 Waterman Way
Tavares, Florida, 32778, United States
Florida Cancer Specialists & Research Institute, 1400 US highway 441 N
The Villages, Florida, 32159, United States
Florida Cancer Specialists
Venice, Florida, 34285, United States
Florida Cancer Specialists
Venice, Florida, 34292, United States
Florida Cancer Specialists & Research Institute - 3730 7th Terrace
Vero Beach, Florida, 32960, United States
Florida Cancer Specialists & Research Institute, 1037 State Road 7 Bldg B
Wellington, Florida, 98374, United States
Florida Cancer Specialists & Research Institute1309 N Flagler Dr
West Palm Beach, Florida, 33401-3406, United States
Florida Cancer Specialists & Research Institute, 2100 Glenwood Drive
Winter Park, Florida, 32792, United States
Atlanta Cancer Center - Alpharetta
Alpharetta, Georgia, 30005, United States
University Cancer & Blood Center, 3320 Old Jefferson Rd
Athens, Georgia, 30607, United States
GCS/Annex
Atlanta, Georgia, 30341, United States
Atlanta Cancer Care - Atlanta
Atlanta, Georgia, 30342, United States
Northside Hospital
Atlanta, Georgia, 30342, United States
GCS/Canton
Canton, Georgia, 30114, United States
Atlanta Cancer Care - Conyers
Conyers, Georgia, 30094, United States
Atlanta Cancer Care - Cumming
Cumming, Georgia, 30041, United States
Atlanta Cancer Care - Decatur
Decatur, Georgia, 30033, United States
GCS/Stemmer
Decatur, Georgia, 30033, United States
Atlanta Cancer Care - Stockbridge
Jonesboro, Georgia, 30236, United States
GCS/Macon
Macon, Georgia, 31217, United States
GCS/Kennestone
Marietta, Georgia, 30060, United States
GCS/Northside
Sandy Springs, Georgia, 30342, United States
Illinois Cancer Specialists
Arlington Heights, Illinois, 60005, United States
University of Chicago Medical Center 5841 S. Maryland Ave
Chicago, Illinois, 60637, United States
University of Chicago Comprehensive Cancer Center at Silver Cross Hospital 1900 Silver Cross Blvd
New Lenox, Illinois, 60451, United States
Illinois Cancer Specialists
Niles, Illinois, 60714-5905, United States
Orland Park - UCMC Center for Advanced Care 14290 South LaGrange Rd
Orland Park, Illinois, 60462, United States
MidAmerica Division Inc. c/o Menorah Medical Center
Overland Park, Kansas, 66209, United States
University of Kansas Cancer Center - The Richard and Annette Bloch Cancer Care Pavilion
Westwood, Kansas, 66205-2005, United States
Maryland Oncology Hematology
Bethesda, Maryland, 20817, United States
Maryland Oncology Hematology
Brandywine, Maryland, 20613, United States
Maryland Oncology Hematology
Clinton, Maryland, 20735, United States
Maryland Oncology Hematology
Columbia, Maryland, 21044, United States
Maryland Oncology Hematology
Rockville, Maryland, 20850, United States
Maryland Oncology Hematology
Silver Spring, Maryland, 20902, United States
Maryland Oncology Hematology
Silver Spring, Maryland, 20904, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02114-2621, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, 02215-5400, United States
Mass General - North Shore Cancer Center ( NSCC )
Danvers, Massachusetts, 01923, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Minnesota Oncology Hematology P.A.
Coon Rapids, Minnesota, 55433, United States
Suburban Imaging Northwest
Coon Rapids, Minnesota, 55433, United States
Suburban Imaging
Coon Rapids, Minnesota, 55433, United States
Mercy Hospital - Unity Campus AHL
Fridley, Minnesota, 55432, United States
Minnesota Oncology Hematology P.A.
Fridley, Minnesota, 55432, United States
Minnesota Oncology Hematology P.A.
Minneapolis, Minnesota, 55404, United States
Abbot Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Virginia G. Piper Cancer Center at HonorHealth
Minneapolis, Minnesota, 55407, United States
Mayo Clinic - 200 First Street SW
Rochester, Minnesota, 55905, United States
Washington University School of Medicine in St. Louis
Creve Coeur, Missouri, 63141, United States
MidAmerica Division Inc. c/o Menorah Medical Center
Independence, Missouri, 64057, United States
Research Medical Center
Kansas City, Missouri, 64132, United States
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63110, United States
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63129, United States
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63136, United States
Nebraska Cancer Specialists - Midwest Cancer Center - Papillion
Omaha, Nebraska, 68114, United States
Nebraska Cancer Specialists - Midwest Cancer Center - Paillion
Omaha, Nebraska, 68130, United States
Nebraska Cancer Specialists- Midwest Cancer Center- Papillion
Papillion, Nebraska, 68046-5706, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
New York Oncology Hematology, P.C.
Albany, New York, 12206, United States
New York Oncology Hematology, P.C.
Clifton Park, New York, 12065, United States
North Shore Hematology Oncology Associates., PC, 235 North Belle Mead Road
East Setauket, New York, 11733, United States
Columbia University Medical Center
New York, New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
North Shore Hematology Oncology Associates., PC, 285 Sills Road Building 16
Patchogue, New York, 11772, United States
UNC Health Care System
Chapel Hill, North Carolina, 27599, United States
The Ohio State University Wexner Medical Center, 460 W 10th Ave
Columbus, Ohio, 432100, United States
The Ohio State University Wexner Medical Center, 1145 Olentangy River Road
Columbus, Ohio, 43212, United States
Providence Medical Group
Portland, Oregon, 97213, United States
UPMC Hillman Cancer Center Mountainview Arnold Palmer Pavilion
Greensburg, Pennsylvania, 15601, United States
UPMC Hillman Cancer Center UPMC East
Monroeville, Pennsylvania, 15146, United States
UPMC Hillman Cancer Center Upper Saint Clair
Pittsburgh, Pennsylvania, 15102, United States
Allegheny-Singer Research Institute, 320 East North Avenue
Pittsburgh, Pennsylvania, 15212, United States
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213, United States
UPMC Hillman Cancer Center UPMC Passavant
Pittsburgh, Pennsylvania, 15237, United States
Tennessee Oncology - Chattanooga Oncology & Hematology Associates
Chattanooga, Tennessee, 37404-1108, United States
Tennesee Oncology - PLLC
Chattanooga, Tennessee, 37404, United States
Tenesse Oncology - PLLC
Cleveland, Tennessee, 37311, United States
Tennessee Oncology, LLC
Dickson, Tennessee, 37055, United States
Tennessee Ocology, LLC
Franklin, Tennessee, 37067, United States
Tennessee Oncology, LLC
Gallatin, Tennessee, 37066, United States
West Cancer Center, 7945 Wolf River Blvd
Germantown, Tennessee, 28138, United States
Tennessee Oncology, LLC
Hermitage, Tennessee, 37076, United States
Tennessee Oncology, LLC
Lebanon, Tennessee, 37090, United States
Tennessee Oncology, LLC
Murfreesboro, Tennessee, 37129, United States
Sarah Cannon Cancer Institute/Tennessee Oncology
Nashville, Tennessee, 37203, United States
Tennessee Oncology, LLC
Nashville, Tennessee, 37203, United States
Vanderbilt Breast Cancer Center at One Hundred Oaks 719 Thompson Lane, Suite 25000
Nashville, Tennessee, 37204, United States
Tennessee Ocology, LLC
Nashville, Tennessee, 37205, United States
Tennessee Oncology, LLC
Nashville, Tennessee, 37207, United States
Tenessee Oncology
Nashville, Tennessee, 37211, United States
Henry-Joyce Cancer Clinic 1301 Medical Center Drive 1903 The Vanderbilt Clinic Nashville, TN 37232
Nashville, Tennessee, 37232, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Tennessee Oncology, LLC
Shelbyville, Tennessee, 37160, United States
Center for Cancer and Blood Disorders
Arlington, Texas, 76014, United States
Center for Cancer and Blood Disorders
Burleson, Texas, 76028, United States
Texas Oncology- Medical City Dallas Building D
Dallas, Texas, 75230-6899, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246-2006, United States
Texas Oncology
Denton, Texas, 76210, United States
Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104-4611, United States
Houston Methodist Hospital - 6565 Fannin St
Houston, Texas, 77030, United States
Texas Oncology-Longview Cancer Center
Longview, Texas, 75601, United States
Texas Oncology
Plano, Texas, 75075-7753, United States
US Oncology
Tyler, Texas, 75702, United States
Center for Cancer and Blood Disorders
Weatherford, Texas, 76086, United States
Virginia Cancer Specialists, PC
Alexandria, Virginia, 22304, United States
Virginia Cancer Specialists, PC
Arlington, Virginia, 22205, United States
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Blacksburg, Virginia, 24060, United States
Virginia Oncology Associates
Chesapeake, Virginia, 23320, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031-4629, United States
Virginia Cancer Specialists, PC
Gainesville, Virginia, 20155, United States
Virginia Oncology Associates
Hampton, Virginia, 23666, United States
Virginia Cancer Specialists, PC
Leesburg, Virginia, 20176, United States
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Low Moor, Virginia, 24457, United States
Virginia Oncology Associates
Newport News, Virginia, 23606, United States
Virginia Oncology Associates, P.C.
Norfolk, Virginia, 23502-0026, United States
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Roanoke, Virginia, 24014, United States
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Salem, Virginia, 24153, United States
Virginia Oncology Associates
Virginia Beach, Virginia, 23456, United States
Virginia Cancer Specialists, PC
Woodbridge, Virginia, 22191, United States
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
Wytheville, Virginia, 24382, United States
Swedish Cancer Institute
Edmonds, Washington, 98026, United States
Swedish Cancer Institute
Issaquah, Washington, 98029, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
Swedish Cancer Institute
Seattle, Washington, 98122, United States
Institut Jules Bordet
Brussels, 1000, Belgium
Universitair Zlekenhuis Brussel
Brussels, 1090, Belgium
UZ Leuven
Leuven, 3000, Belgium
Clinique et Maternite Sainte-Elisabeth
Namur, 5000, Belgium
Cross Cancer Institute, 11560 University Avenue
Edmonton, Alberta, TG6 1Z2, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 1V7, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Jewish General Hospital, 3755 Côte-Sainte-Catherine
Montreal, Quebec, H3T 1E2, Canada
Jewish General Hospital, 3755 Côte-Sainte-Catherine
Québec, Quebec, H3T 1E2, Canada
Centre de Lutte Contre le Cancer - Institut de Cancerologie de l'Ouest - Paul Papin
Angers, 49005, France
CHU Besançon - Hôpital Jean Minjoz
Besançon, 25000, France
Institut Régional du Cancer de Montpellier
Montpellier, France
Institut Curie
Paris, 75248, France
Centre Eugène Marquis
Rennes, 35042, France
Florence Lerebours
Saint-Cloud, 92210, France
CHU de Nantes - Hôpital Nord Laennec
Saint-Herblain, 44805, France
Institut Claudius Regaud
Toulouse, 31059, France
Gustave Roussy
Villejuif, 94800, France
Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus
Frankfurt, 60389, Germany
Praxis für interdisziplinäre Onkologie & Hämatologie GbR
Freiburg im Breisgau, 79110, Germany
Facharztzentrum Eppendorf
Hamburg, 20249, Germany
Institut für Versorgungsforschung in der Onkologie
Koblenz, 56068, Germany
Praxis für Hämatologie und Internistische Onkologie
Velbert, 42551, Germany
Hospital Teresa Herrera, As Xubias, 84
A Coruña, 15006, Spain
Hospital Quirón Barcelona, Plaza Alfonso Comín 5
Barcelona, 08023, Spain
Hospital del Mar
Barcelona, 8003, Spain
Hospital Universitario Vall d'Hebron
Barcelona, 8035, Spain
Hospital de la Santa Creu i Sant Pau, Carrer del Mas Casanovas, 90
Barcelona, 8041, Spain
Institut Catala d'Oncologia Hospitalet, Avenida Gran Via 199-203
L'Hospitalet de Llobregat, 08908, Spain
Hospital Universitari Arnau de Vilanova de Lleida
Lleida, 25195, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Complexo Hospitalario Universitario de Santiago (CHUS) - Hospital Clinco Universaitario
Santiago de Compostela, 15706, Spain
Hospital Universitario Virgen del Rocío
Seville, 41013, Spain
Colchester Hospital University NHS Foundation Trust - Colchester General Hospital, Turner Road
Colchester, ESS, C04 5JL, United Kingdom
The Arden Cancer Centre- University Hospital Coventry
Coventry, CV2 2DX, United Kingdom
County Durham and Darlington NHS Foundation Trust - University Hospital of North Durham
Durham, DH1 5TW, United Kingdom
The Royal Surrey County Hospital NHS Foundation Trust
Guildford, GU2 7XX, United Kingdom
The County Hospital, Wye Valley NHS Trust
Hereford, HR1 2BN, United Kingdom
The Royal Free London NHS Foundation Trust - The Royal Free Hospital, Pond Street Oncology & Haematology Clinical Trials Unit Dept. of Academic Oncology
London, NW3 2QG, United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Nottingham University Hospitals NHS Trust - City Hospital
Nottingham, NG5 1PB, United Kingdom
Plymouth Hospitals NHS Trust - Derriford Hospital
Plymouth, PL6 8DH, United Kingdom
Taunton and Somerset NHS Foundation Trust - Musgrove Park Hospital, Musgrove Park Hospital
Taunton, TA1 5DA, United Kingdom
The Mid Yorkshire Hospitals NHS Trust - Pinderfields Hospital
Wakefield, WF1 4DG, United Kingdom
Related Publications (14)
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.
PMID: 30786188BACKGROUNDHuvitz 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.
RESULTDieras 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.
RESULTRugo 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.
RESULTBardia 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
RESULTBardia 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
RESULTLoibl S, Loirat D, Tolaney SM, Punie K, Dieras V, Carey LA, Gianni L, Shah A, Phan S, Shi L, Spears PA, Piccart MJ. Summary of quality of life in the ASCENT phase 3 clinical trial for people with metastatic triple-negative breast cancer. Future Oncol. 2024;20(34):2609-2616. doi: 10.1080/14796694.2024.2381408. Epub 2024 Sep 26.
PMID: 39324726DERIVEDHurvitz SA, Bardia A, Punie K, Kalinsky K, Carey LA, Rugo HS, Dieras V, Phan S, Delaney R, Zhu Y, Tolaney SM. Subgroup analyses from the phase 3 ASCENT study of sacituzumab govitecan in metastatic triple-negative breast cancer. NPJ Breast Cancer. 2024 Apr 25;10(1):33. doi: 10.1038/s41523-024-00635-5.
PMID: 38664404DERIVEDBardia A, Rugo HS, Tolaney SM, Loirat D, Punie K, Oliveira M, Brufsky A, Kalinsky K, Cortes J, Shaughnessy JO, Dieras V, Carey LA, Gianni L, Piccart-Gebhart M, Loibl S, Yoon OK, Pan Y, Hofsess S, Phan SC, Hurvitz SA. Final Results From the Randomized Phase III ASCENT Clinical Trial in Metastatic Triple-Negative Breast Cancer and Association of Outcomes by Human Epidermal Growth Factor Receptor 2 and Trophoblast Cell Surface Antigen 2 Expression. J Clin Oncol. 2024 May 20;42(15):1738-1744. doi: 10.1200/JCO.23.01409. Epub 2024 Feb 29.
PMID: 38422473DERIVEDO'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.
PMID: 35545724DERIVEDBardia 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.
PMID: 34467774DERIVEDBardia 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.
PMID: 33882206DERIVEDMcCann 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.
PMID: 33093337DERIVEDSeligson 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.
PMID: 33070624DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gilead Clinical Study Information Center
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2015
First Posted
October 12, 2015
Study Start
November 7, 2017
Primary Completion
March 30, 2020
Study Completion
December 8, 2020
Last Updated
June 15, 2022
Results First Posted
April 30, 2021
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 18 months after study completion
- Access Criteria
- A secured external environment with username, password, and RSA code.
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/