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AzTrials

Breast CancerPhase 3ASCENTNCT02574455

Trial of Sacituzumab Govitecan in Participants With Refractory/Relapsed Metastatic Triple-Negative Breast Cancer (TNBC)

A Phase 3 study testing Sacituzumab govitecan, Eribulin and Capecitabine in people with Breast Cancer, run by Gilead Sciences at 230 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Sacituzumab govitecan, Eribulin and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
529 participants
Where
230 sitesin 7 countries
Study dates
7 Nov 2017to 8 Dec 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.

Trial locations and contacts

230 sites in 7 countries.

230 sites in 7 countries

United States185 sites

  • New York Oncology Hematology, P.C.

    Albany, New York, 12206

  • Virginia Cancer Specialists, PC

    Alexandria, Virginia, 22304

  • UCLA Jonsson Comprehensive Cancer Center, 1411 S. Garfield Ave Suite 200

    Alhambra, California, 91801

  • Atlanta Cancer Center - Alpharetta

    Alpharetta, Georgia, 30005

  • Florida Cancer Specialists & Research Institute, 601 E. Altamonte Drive

    Altamonte Springs, Florida, 32701

  • Center for Cancer and Blood Disorders

    Arlington, Texas, 76014

  • Virginia Cancer Specialists, PC

    Arlington, Virginia, 22205

  • Illinois Cancer Specialists

    Arlington Heights, Illinois, 60005

  • University Cancer & Blood Center, 3320 Old Jefferson Rd

    Athens, Georgia, 30607

  • GCS/Annex

    Atlanta, Georgia, 30341

  • Atlanta Cancer Care - Atlanta

    Atlanta, Georgia, 30342

  • Northside Hospital

    Atlanta, Georgia, 30342

  • Rocky Mountain Cancer Centers, 1700 South Potomac Street

    Aurora, Colorado, 80012-5405

  • University of Colorado Hospital - Anschutz Cancer Pavilion, 1665 Aurora Court

    Aurora, Colorado, 80045

  • Maryland Oncology Hematology

    Bethesda, Maryland, 20817

  • Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

    Blacksburg, Virginia, 24060

  • Florida Cancer Specialist

    Bonita Springs, Florida, 34135

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02114-2621

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center (BIDMC)

    Boston, Massachusetts, 02215-5400

  • Rocky Mountain Cancer Centers, 4715 Arapahoe Ave

    Boulder, Colorado, 80303

  • Florida Cancer Specialists

    Bradenton, Florida, 34209

  • Florida Cancer Specialists & Research Institute, 403 S. King Ave

    Brandon, Florida, 33511

  • Maryland Oncology Hematology

    Brandywine, Maryland, 20613

  • UCLA Jonsson Comprehensive Cancer Center, 201. S. Buena Vista St Suite 200

    Burbank, California, 91505

  • Center for Cancer and Blood Disorders

    Burleson, Texas, 76028

  • GCS/Canton

    Canton, Georgia, 30114

  • Florida Cancer Specialists

    Cape Coral, Florida, 33914

  • UNC Health Care System

    Chapel Hill, North Carolina, 27599

  • Tennessee Oncology - Chattanooga Oncology & Hematology Associates

    Chattanooga, Tennessee, 37404-1108

  • Tennesee Oncology - PLLC

    Chattanooga, Tennessee, 37404

  • Virginia Oncology Associates

    Chesapeake, Virginia, 23320

  • University of Chicago Medical Center 5841 S. Maryland Ave

    Chicago, Illinois, 60637

  • Florida Cancer Specialists & Research Institute, 3280 McMullen Booth road

    Clearwater, Florida, 33761

  • Tenesse Oncology - PLLC

    Cleveland, Tennessee, 37311

  • New York Oncology Hematology, P.C.

    Clifton Park, New York, 12065

  • Maryland Oncology Hematology

    Clinton, Maryland, 20735

  • Rocky Mountain Cancer Centers, 2312 N. Nevada Avenue, Suite 400

    Colorado Springs, Colorado, 80907

  • Maryland Oncology Hematology

    Columbia, Maryland, 21044

  • The Ohio State University Wexner Medical Center, 460 W 10th Ave

    Columbus, Ohio, 432100

  • The Ohio State University Wexner Medical Center, 1145 Olentangy River Road

    Columbus, Ohio, 43212

  • Atlanta Cancer Care - Conyers

    Conyers, Georgia, 30094

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Minnesota Oncology Hematology P.A.

    Coon Rapids, Minnesota, 55433

  • Suburban Imaging Northwest

    Coon Rapids, Minnesota, 55433

  • Suburban Imaging

    Coon Rapids, Minnesota, 55433

  • Sylvester Comprehensive Cancer Center

    Coral Gables, Florida, 33146

  • Washington University School of Medicine in St. Louis

    Creve Coeur, Missouri, 63141

  • Atlanta Cancer Care - Cumming

    Cumming, Georgia, 30041

  • Texas Oncology- Medical City Dallas Building D

    Dallas, Texas, 75230-6899

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246-2006

  • Mass General - North Shore Cancer Center ( NSCC )

    Danvers, Massachusetts, 01923

  • Southern Cancer Center, 29653 Anchor Cross Blvd

    Daphne, Alabama, 36526

  • Florida Cancer Specialists & Research Institute, 224 Memorial medical Parway

    Daytona Beach, Florida, 32117

  • Atlanta Cancer Care - Decatur

    Decatur, Georgia, 30033

  • GCS/Stemmer

    Decatur, Georgia, 30033

  • Sylvester Comprehensive Cancer Center

    Deerfield Beach, Florida, 33442

  • Texas Oncology

    Denton, Texas, 76210

  • Rocky Mountain Cancer Centers, 1800 Williams St.

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers, 4700 E. Hale Parkway, Suite 400

    Denver, Colorado, 80220

  • Tennessee Oncology, LLC

    Dickson, Tennessee, 37055

  • North Shore Hematology Oncology Associates., PC, 235 North Belle Mead Road

    East Setauket, New York, 11733

  • Swedish Cancer Institute

    Edmonds, Washington, 98026

  • Rocky Mountain Cancer Centers, 499 E Hampden Ave Suite 450

    Englewood, Colorado, 80113

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031-4629

  • Florida Cancer Specialists

    Fort Myers, Florida, 33905

  • Center for Cancer and Blood Disorders

    Fort Worth, Texas, 76104-4611

  • Tennessee Ocology, LLC

    Franklin, Tennessee, 37067

  • Mercy Hospital - Unity Campus AHL

    Fridley, Minnesota, 55432

  • Minnesota Oncology Hematology P.A.

    Fridley, Minnesota, 55432

  • Florida Cancer Specialists & Research Institute, 6420 W Newberry Road Est Wing

    Gainesville, Florida, 32605

  • Virginia Cancer Specialists, PC

    Gainesville, Virginia, 20155

  • Tennessee Oncology, LLC

    Gallatin, Tennessee, 37066

  • West Cancer Center, 7945 Wolf River Blvd

    Germantown, Tennessee, 28138

  • UPMC Hillman Cancer Center Mountainview Arnold Palmer Pavilion

    Greensburg, Pennsylvania, 15601

  • Virginia Oncology Associates

    Hampton, Virginia, 23666

  • Tennessee Oncology, LLC

    Hermitage, Tennessee, 37076

  • Houston Methodist Hospital - 6565 Fannin St

    Houston, Texas, 77030

  • MidAmerica Division Inc. c/o Menorah Medical Center

    Independence, Missouri, 64057

  • Swedish Cancer Institute

    Issaquah, Washington, 98029

  • Atlanta Cancer Care - Stockbridge

    Jonesboro, Georgia, 30236

  • Research Medical Center

    Kansas City, Missouri, 64132

  • UCLA Jonsson Comprehensive Cancer Center

    Laguna Hills, California, 92653

  • Rocky Mountain Cancer Centers, 11750 West 2nd Place, Suite 1-100

    Lakewood, Colorado, 80228

  • Florida Cancer Specialists & Research Institute, 100 Highland Avenue

    Largo, Florida, 33770

  • Tennessee Oncology, LLC

    Lebanon, Tennessee, 37090

  • Florida Cancer Specialists & Research Institute, 521 N. Lecanto Highway

    Lecanto, Florida, 34461

  • Virginia Cancer Specialists, PC

    Leesburg, Virginia, 20176

  • Rocky Mountain Cancer Centers, 22 West Dry Creek Circle

    Littleton, Colorado, 80120

  • Rocky Mountain Cancer Centers, 10103 Ridge Gate Parkway, Suite G-01

    Lone Tree, Colorado, 80124

  • Rocky Mountain Cancer Centers, 2030 W Mountain View Avenue, Ste. 210

    Longmont, Colorado, 80501

  • Texas Oncology-Longview Cancer Center

    Longview, Texas, 75601

  • UCLA Jonsson Comprehensive Cancer Center, 200 UCLA Medical Plaza

    Los Angeles, California, 90095

  • Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

    Low Moor, Virginia, 24457

  • GCS/Macon

    Macon, Georgia, 31217

  • GCS/Kennestone

    Marietta, Georgia, 30060

  • Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • Baptist Health Medical Group Oncology, LLC

    Miami, Florida, 33176

  • Minnesota Oncology Hematology P.A.

    Minneapolis, Minnesota, 55404

  • Abbot Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Virginia G. Piper Cancer Center at HonorHealth

    Minneapolis, Minnesota, 55407

  • Souther Cancer Center, 3719 Dauphin St., 5 Floor

    Mobile, Alabama, 36608

  • Southern Cancer Center, 3 Mobile Infirmary Circle

    Mobile, Alabama, 36608

  • Southern Cancer Center, 6701 Airport Blvd., Bldg B, Terace Level

    Mobile, Alabama, 36608

  • UPMC Hillman Cancer Center UPMC East

    Monroeville, Pennsylvania, 15146

  • Tennessee Oncology, LLC

    Murfreesboro, Tennessee, 37129

  • Florida Cancer Specialists

    Naples, Florida, 34102

  • Sarah Cannon Cancer Institute/Tennessee Oncology

    Nashville, Tennessee, 37203

  • Tennessee Oncology, LLC

    Nashville, Tennessee, 37203

  • Vanderbilt Breast Cancer Center at One Hundred Oaks 719 Thompson Lane, Suite 25000

    Nashville, Tennessee, 37204

  • Tennessee Ocology, LLC

    Nashville, Tennessee, 37205

  • Tennessee Oncology, LLC

    Nashville, Tennessee, 37207

  • Tenessee Oncology

    Nashville, Tennessee, 37211

  • Henry-Joyce Cancer Clinic 1301 Medical Center Drive 1903 The Vanderbilt Clinic Nashville, TN 37232

    Nashville, Tennessee, 37232

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Yale School Of Medicine

    New Haven, Connecticut, 06510-3206

  • University of Chicago Comprehensive Cancer Center at Silver Cross Hospital 1900 Silver Cross Blvd

    New Lenox, Illinois, 60451

  • Florida Cancer Specialists & Research Institute, 8763 River Crossing Blvd

    New Port Richey, Florida, 34655

  • Columbia University Medical Center

    New York, New York, 10032

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Virginia Oncology Associates

    Newport News, Virginia, 23606

  • Illinois Cancer Specialists

    Niles, Illinois, 60714-5905

  • Virginia Oncology Associates, P.C.

    Norfolk, Virginia, 23502-0026

  • Norwalk Hospital, 34 Maple Street

    Norwalk, Connecticut, 06856

  • Florida Cancer Specialists & Research Institute, 1630 SE 18th ST

    Ocala, Florida, 34471

  • Nebraska Cancer Specialists - Midwest Cancer Center - Papillion

    Omaha, Nebraska, 68114

  • Nebraska Cancer Specialists - Midwest Cancer Center - Paillion

    Omaha, Nebraska, 68130

  • Florida Cancer Specialists & Research Institute, 765 Image Way

    Orange City, Florida, 32763

  • Orland Park - UCMC Center for Advanced Care 14290 South LaGrange Rd

    Orland Park, Illinois, 60462

  • Orlando Regional Medical Center

    Orlando, Florida, 32806-2008

  • Florida Cancer Specialists & Research Institute, 70 W Gore Street

    Orlando, Florida, 32806

  • Florida Cancer Specialists & Research Institute - 325 Clyde Morris

    Ormond Beach, Florida, 32774

  • MidAmerica Division Inc. c/o Menorah Medical Center

    Overland Park, Kansas, 66209

  • Nebraska Cancer Specialists- Midwest Cancer Center- Papillion

    Papillion, Nebraska, 68046-5706

  • Rocky Mountain Cancer Centers, 9397 Crown Crest Blvd., Suite 421

    Parker, Colorado, 80138

  • UCLA Jonsson Comprehensive Cancer Center, 625 South Fair Oaks Avenue Suite 320

    Pasadena, California, 91105

  • North Shore Hematology Oncology Associates., PC, 285 Sills Road Building 16

    Patchogue, New York, 11772

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054

  • UPMC Hillman Cancer Center Upper Saint Clair

    Pittsburgh, Pennsylvania, 15102

  • Allegheny-Singer Research Institute, 320 East North Avenue

    Pittsburgh, Pennsylvania, 15212

  • Magee-Womens Hospital of UPMC

    Pittsburgh, Pennsylvania, 15213

  • UPMC Hillman Cancer Center UPMC Passavant

    Pittsburgh, Pennsylvania, 15237

  • Texas Oncology

    Plano, Texas, 75075-7753

  • Sylvester Comprehensive Cancer Center

    Plantation, Florida, 33324

  • Florida Cancer Specialists

    Port Charlotte, Florida, 33980

  • Providence Medical Group

    Portland, Oregon, 97213

  • Rocky Mountain Cancer Centers, 3676 Parker Blvd., Suite 350

    Pueblo, Colorado, 81008

  • Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

    Roanoke, Virginia, 24014

  • Mayo Clinic - 200 First Street SW

    Rochester, Minnesota, 55905

  • Maryland Oncology Hematology

    Rockville, Maryland, 20850

  • Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

    Salem, Virginia, 24153

  • University of California, San Francisco (UCSF) - Innovation, Technology & Alliances, 1600 Divisadero Street

    San Francisco, California, 94115

  • GCS/Northside

    Sandy Springs, Georgia, 30342

  • UCLA Jonsson Comprehensive Cancer Center, 2020 Santa Monica Boulevard

    Santa Monica, California, 94115

  • Florida Cancer Specialists

    Sarasota, Florida, 34236

  • Mayo Clinic Hospital

    Scottsdale, Arizona, 85259

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Swedish Cancer Institute

    Seattle, Washington, 98122

  • Tennessee Oncology, LLC

    Shelbyville, Tennessee, 37160

  • Maryland Oncology Hematology

    Silver Spring, Maryland, 20902

  • Maryland Oncology Hematology

    Silver Spring, Maryland, 20904

  • Florida Cancer Specialists & Research Institute, 7154 Medical Center Drive

    Spring Hill, Florida, 34608

  • Washington University School of Medicine in St. Louis

    St Louis, Missouri, 63110

  • Washington University School of Medicine in St. Louis

    St Louis, Missouri, 63129

  • Washington University School of Medicine in St. Louis

    St Louis, Missouri, 63136

  • Florida Cancer Specialists & Research Institute, 1201 Fifth Avenue North

    St. Petersburg, Florida, 33705-1449

  • Florida Cancer Specialists & Research Institute, 560 Jackson St

    St. Petersburg, Florida, 33705

  • Florida Cancer Specialists & Research Institute, 3402 W Dr. Martin Luther King Jr Boulevard

    Tampa, Florida, 33607

  • Florida Cancer Specialists & Research Institute, 4100 Waterman Way

    Tavares, Florida, 32778

  • Florida Cancer Specialists & Research Institute, 1400 US highway 441 N

    The Villages, Florida, 32159

  • Rocky Mountain Cancer Centers, 8820 Huron Street

    Thornton, Colorado, 80260

  • US Oncology

    Tyler, Texas, 75702

  • Florida Cancer Specialists

    Venice, Florida, 34285

  • Florida Cancer Specialists

    Venice, Florida, 34292

  • Florida Cancer Specialists & Research Institute - 3730 7th Terrace

    Vero Beach, Florida, 32960

  • Virginia Oncology Associates

    Virginia Beach, Virginia, 23456

  • Georgetown Lombardi Comprehensive Cancer Center

    Washington D.C., District of Columbia, 20007

  • Center for Cancer and Blood Disorders

    Weatherford, Texas, 76086

  • Florida Cancer Specialists & Research Institute, 1037 State Road 7 Bldg B

    Wellington, Florida, 98374

  • Florida Cancer Specialists & Research Institute1309 N Flagler Dr

    West Palm Beach, Florida, 33401-3406

  • University of Kansas Cancer Center - The Richard and Annette Bloch Cancer Care Pavilion

    Westwood, Kansas, 66205-2005

  • Florida Cancer Specialists & Research Institute, 2100 Glenwood Drive

    Winter Park, Florida, 32792

  • Virginia Cancer Specialists, PC

    Woodbridge, Virginia, 22191

  • Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

    Wytheville, Virginia, 24382

Other trials in United States

Spain11 sites

  • Hospital Teresa Herrera, As Xubias, 84

    A Coruña, 15006

  • Hospital Quirón Barcelona, Plaza Alfonso Comín 5

    Barcelona, 08023

  • Hospital del Mar

    Barcelona, 8003

  • Hospital Universitario Vall d'Hebron

    Barcelona, 8035

  • Hospital de la Santa Creu i Sant Pau, Carrer del Mas Casanovas, 90

    Barcelona, 8041

  • Institut Catala d'Oncologia Hospitalet, Avenida Gran Via 199-203

    L'Hospitalet de Llobregat, 08908

  • Hospital Universitari Arnau de Vilanova de Lleida

    Lleida, 25195

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Complexo Hospitalario Universitario de Santiago (CHUS) - Hospital Clinco Universaitario

    Santiago de Compostela, 15706

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

Other trials in Spain

United Kingdom11 sites

  • Colchester Hospital University NHS Foundation Trust - Colchester General Hospital, Turner Road

    Colchester, ESS, C04 5JL

  • The Arden Cancer Centre- University Hospital Coventry

    Coventry, CV2 2DX

  • County Durham and Darlington NHS Foundation Trust - University Hospital of North Durham

    Durham, DH1 5TW

  • The Royal Surrey County Hospital NHS Foundation Trust

    Guildford, GU2 7XX

  • The County Hospital, Wye Valley NHS Trust

    Hereford, HR1 2BN

  • 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

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • Nottingham University Hospitals NHS Trust - City Hospital

    Nottingham, NG5 1PB

  • Plymouth Hospitals NHS Trust - Derriford Hospital

    Plymouth, PL6 8DH

  • Taunton and Somerset NHS Foundation Trust - Musgrove Park Hospital, Musgrove Park Hospital

    Taunton, TA1 5DA

  • The Mid Yorkshire Hospitals NHS Trust - Pinderfields Hospital

    Wakefield, WF1 4DG

Other trials in United Kingdom

France9 sites

  • Centre de Lutte Contre le Cancer - Institut de Cancerologie de l'Ouest - Paul Papin

    Angers, 49005

  • CHU Besançon - Hôpital Jean Minjoz

    Besançon, 25000

  • Institut Régional du Cancer de Montpellier

    Montpellier

  • Institut Curie

    Paris, 75248

  • Centre Eugène Marquis

    Rennes, 35042

  • Florence Lerebours

    Saint-Cloud, 92210

  • CHU de Nantes - Hôpital Nord Laennec

    Saint-Herblain, 44805

  • Institut Claudius Regaud

    Toulouse, 31059

  • Gustave Roussy

    Villejuif, 94800

Other trials in France

Canada5 sites

  • Cross Cancer Institute, 11560 University Avenue

    Edmonton, Alberta, TG6 1Z2

  • Queen Elizabeth II Health Sciences Centre

    Halifax, Nova Scotia, B3H 1V7

  • Jewish General Hospital, 3755 Côte-Sainte-Catherine

    Montreal, Quebec, H3T 1E2

  • Jewish General Hospital, 3755 Côte-Sainte-Catherine

    Québec, Quebec, H3T 1E2

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

Germany5 sites

  • Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus

    Frankfurt, 60389

  • Praxis für interdisziplinäre Onkologie & Hämatologie GbR

    Freiburg im Breisgau, 79110

  • Facharztzentrum Eppendorf

    Hamburg, 20249

  • Institut für Versorgungsforschung in der Onkologie

    Koblenz, 56068

  • Praxis für Hämatologie und Internistische Onkologie

    Velbert, 42551

Other trials in Germany

Belgium4 sites

  • Institut Jules Bordet

    Brussels, 1000

  • Universitair Zlekenhuis Brussel

    Brussels, 1090

  • UZ Leuven

    Leuven, 3000

  • Clinique et Maternite Sainte-Elisabeth

    Namur, 5000

Other trials in Belgium

About this study

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

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.

Conditions
Breast Cancer
Being tested
Sacituzumab govitecan, Eribulin, Capecitabine, Gemcitabine, Vinorelbine
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sacituzumab govitecanDrug

    Also called IMMU-132, Trodelvy®

    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.

  • EribulinDrug

    Also called Halaven

    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).

  • CapecitabineDrug

    Also called Xeloda

    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.

  • GemcitabineDrug

    Also called Gemzar

    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.

  • VinorelbineDrug

    Also called Navelbine

    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.

Study groups in NCT02574455
Study groupRoleWhat they receive
Sacituzumab GovitecanExperimentalParticipants 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).
Receives: Drug: Sacituzumab govitecan
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.
Receives: Drug: Eribulin; Drug: Capecitabine; Drug: Gemcitabine; Drug: Vinorelbine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. Progression-Free Survival (PFS) by IRC Assessment in the ITT Population

    PFS was defined as the time from randomization until objective tumor progression by 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 (≥20%) in the sum of the target lesions or the appearance of new non-target lesions. PFS was estimated using Kaplan-Meier estimate.

    Measured: 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)

  2. Overall Survival (OS) in BM-ve Population

    Overall survival (OS) was defined as the time from the randomization to death from any cause. OS was estimated using Kaplan-Meier estimate.

    Measured: From the randomization to death from any cause (maximum follow-up duration: 30.8 months)

  3. Overall Survival (OS) in ITT Population

    Overall survival (OS) was defined as the time from the randomization to death from any cause. OS was estimated using Kaplan-Meier estimate.

    Measured: From the randomization to death from any cause (maximum follow-up duration: 30.8 months)

  4. Objective Response Rate (ORR) by IRC and Investigator Assessment in BM-ve Population

    ORR was defined as the percentage of participants who had the overall best response as either a confirmed complete response (CR) or partial response (PR) relative to the size of population under evaluation. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; and no new lesions.

    Measured: 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)

  5. Time to Objective Response by the Investigator Assessment in BM-ve Population

    Time to response was defined as the time from randomization to the first recorded objective response (ie, CR or PR). CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions.

    Measured: 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)

  6. Time to Objective Response by the IRC Assessment in BM-ve Population

    Time to response was defined as the time from randomization to the first recorded objective response (ie, CR or PR). CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions.

    Measured: 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)

  7. Duration of Response (DOR) by IRC and Investigator Assessment in BM-ve Population

    DOR was defined as the number of days between the first date showing a documented response of CR or PR and the date of progression or death. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions.

    Measured: 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)

  8. Time to Progression (TTP) by Investigator Assessment in BM-ve Population

    Time to Progression (TTP) was defined as the time from the date of randomization to the date of the first evidence of disease progression as assessed using RECIST 1.1 criteria. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions. Participants without progression were censored.

    Measured: 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)

  9. Time to Progression (TTP) by IRC Assessment in BM-ve Population

    Time to Progression (TTP) was defined as the time from the date of randomization to the date of the first evidence of disease progression as assessed using RECIST 1.1 criteria. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions. Participants without progression were censored.

    Measured: 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)

  10. Clinical Benefit Rate (CBR) by IRC and Investigator Assessment in BM-ve Population

    CBR was defined as the percentage of participants with best response as either CR, PR, or stable disease (SD) with a duration of ≥6 months. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; and Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. PD: ≥20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since treatment started or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

    Measured: 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)

  11. Percentage of Participants Experiencing Any Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation of Study Drug

    Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.03. An AE that met one or more of the following outcomes was classified as serious:

    • Fatal
    • Life-threatening
    • Disabling/incapacitating
    • Results in hospitalization or prolongs a hospital stay
    • A congenital abnormality
    • Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above

    Measured: First dose date up to last follow-up (maximum up to 30.8 months)

  12. Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ-C30) Score

    The EORTC QLQ-C30 is a questionnaire to assess quality of life (QoL), it is composed of 30 questions (items) resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, pain), and 6 single items (dyspnea, insomnia, loss of appetite, constipation, diarrhea, financial difficulties). All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status indicate a better quality of life; a positive change from baseline indicates improvement. Lower scores on the symptom and single-item scales indicate a better quality of life; a negative change from baseline indicates improvement.

    Measured: Baseline; End of Treatment (EOT) (up to 29.6 months)

  13. Percentage of Participants Experiencing the Worst Laboratory Abnormalities Grade 3 or 4 Post-Baseline

    Blood samples were collected for hematology, serum chemistry and the laboratory abnormalities were assessed. The most severe graded abnormality observed post-baseline for each graded test was counted for each participant. Safety as assessed by grading of laboratory values and AEs according to the National Cancer Institutes' Common Terminology Criteria for Adverse Events (NCI CTCAE) covering grades 0-5 (0=Normal, 1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening, 5=Death). The percentage of participants with worst postbaseline grades 3 or 4 are reported.

    Measured: First dose date up to last follow-up (maximum up to 30.8 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2015 (estimated)
  2. Study start7 Nov 2017
  3. Primary completion30 Mar 2020
  4. Study completion8 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
529 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02574455
Sponsor's protocol ID
IMMU-132-05
Other IDs
2017-003019-21, 2017
Acronym
ASCENT
Status last verified
May 2022
First submitted
8 Oct 2015
Last updated
15 Jun 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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/

Publications

  • 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.

    PubMed 30786188

  • 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.

  • 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.

  • 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.

  • 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

  • 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

  • Sathe AG, Jones AK, Diderichsen PM, Wang X, Chang P, Verret W, Girish S. Sacituzumab Govitecan Population Pharmacokinetics: Updated Analyses Using HR+/HER2- Metastatic Breast Cancer Data From the Phase 3 TROPiCS-02 Trial. Clin Transl Sci. 2025 Jul;18(7):e70291. doi: 10.1111/cts.70291.

    PubMed 40657894

  • Loibl 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.

    PubMed 39324726

  • Hurvitz 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.

    PubMed 38664404

  • Bardia 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.

    PubMed 38422473

  • 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.

    PubMed 35545724

  • 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.

    PubMed 34467774

  • 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.

    PubMed 33882206

  • 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.

    PubMed 33093337

  • 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.

    PubMed 33070624

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sacituzumab govitecan, Eribulin and Capecitabine in people with Breast Cancer, run by Gilead Sciences at 230 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 230 sites in United States, Spain, United Kingdom, France, Canada and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) by Independent Review Committee (IRC) Assessment in Brain Metastasis Negative (BM-ve) Population (time frame: 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02574455, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2022.

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