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

May 26, 2022 updated by: Gilead Sciences

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.

Study Overview

Status

Completed

Conditions

Breast Cancer

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

529

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Belgium
- - Brussels, Belgium, 1090
    - Universitair Zlekenhuis Brussel
  - Bruxelles, Belgium, 1000
    - Institut Jules Bordet
  - Leuven, Belgium, 3000
    - UZ Leuven
  - Namur, Belgium, 5000
    - Clinique et Maternité Sainte-Elisabeth
Canada
- Alberta
  - Edmonton, Alberta, Canada, TG6 1Z2
    - Cross Cancer Institute, 11560 University Avenue
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 1V7
    - Queen Elizabeth II Health Sciences Centre
- Ontario
  - Toronto, Ontario, Canada, M4N 3M5
    - Sunnybrook Health Sciences Centre
- Quebec
  - Montréal, Quebec, Canada, H3T 1E2
    - Jewish General Hospital, 3755 Côte-Sainte-Catherine
  - Québec, Quebec, Canada, H3T 1E2
    - Jewish General Hospital, 3755 Côte-Sainte-Catherine
France
- - Angers, France, 49005
    - Centre de Lutte Contre le Cancer - Institut de Cancerologie de l'Ouest - Paul Papin
  - Besançon, France, 25000
    - CHU Besancon - Hopital Jean Minjoz
  - Montpellier, France
    - Institut régional du Cancer de Montpellier
  - Paris, France, 75248
    - Institut Curie
  - Rennes Cedex, France, 35042
    - Centre Eugène Marquis
  - Saint-Cloud, France, 92210
    - Florence Lerebours
  - Saint-Herblain, France, 44805
    - CHU de Nantes - Hopital Nord Laennec
  - Toulouse, France, 31059
    - Institut Claudius Regaud
  - Villejuif, France, 94800
    - Gustave Roussy
Germany
- - Frankfurt, Germany, 60389
    - Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus
  - Freiburg im Breisgau, Germany, 79110
    - Praxis fur interdisziplinare Onkologie & Hamatologie GbR
  - Hamburg, Germany, 20249
    - Facharztzentrum Eppendorf
  - Koblenz, Germany, 56068
    - Institut für Versorgungsforschung in der Onkologie
  - Velbert, Germany, 42551
    - Praxis für Hämatologie und Internistische Onkologie
Spain
- - A Coruña, Spain, 15006
    - Hospital Teresa Herrera, As Xubias, 84
  - Barcelona, Spain, 8003
    - Hospital del Mar
  - Barcelona, Spain, 8035
    - Hospital Universitario Vall d'Hebron
  - Barcelona, Spain, 08023
    - Hospital Quirón Barcelona, Plaza Alfonso Comín 5
  - Barcelona, Spain, 8041
    - Hospital de la Santa Creu i Sant Pau, Carrer del Mas Casanovas, 90
  - Hospitalet de Llobregat, Spain, 08908
    - Institut Catala d'Oncologia Hospitalet, Avenida Gran Via 199-203
  - Lleida, Spain, 25195
    - Hospital Universitari Arnau de Vilanova de Lleida
  - Madrid, Spain, 28034
    - Hospital Universitario Ramon y Cajal
  - Madrid, Spain, 28041
    - Hospital Universitario 12 de Octubre
  - Santiago De Compostela, Spain, 15706
    - Complexo Hospitalario Universitario de Santiago (CHUS) - Hospital Clinco Universaitario
  - Sevilla, Spain, 41013
    - Hospital Universitario Virgen del Rocio
United Kingdom
- - Coventry, United Kingdom, CV2 2DX
    - The Arden Cancer Centre- University Hospital Coventry
  - Durham, United Kingdom, DH1 5TW
    - County Durham and Darlington NHS Foundation Trust - University Hospital of North Durham
  - Guildford, United Kingdom, GU2 7XX
    - The Royal Surrey County Hospital NHS Foundation Trust
  - Hereford, United Kingdom, HR1 2BN
    - The County Hospital, Wye Valley NHS Trust
  - London, United Kingdom, NW3 2QG
    - The Royal Free London NHS Foundation Trust - The Royal Free Hospital, Pond Street Oncology & Haematology Clinical Trials Unit Dept. of Academic Oncology
  - Manchester, United Kingdom, M20 4BX
    - The Christie NHS Foundation Trust
  - Nottingham, United Kingdom, NG5 1PB
    - Nottingham University Hospitals NHS Trust - City Hospital
  - Plymouth, United Kingdom, PL6 8DH
    - Plymouth Hospitals NHS Trust - Derriford Hospital
  - Taunton, United Kingdom, TA1 5DA
    - Taunton and Somerset NHS Foundation Trust - Musgrove Park Hospital, Musgrove Park Hospital
  - Wakefield, United Kingdom, WF1 4DG
    - The Mid Yorkshire Hospitals NHS Trust - Pinderfields Hospital
- ESS
  - Colchester, ESS, United Kingdom, C04 5JL
    - Colchester Hospital University NHS Foundation Trust - Colchester General Hospital, Turner Road
United States
- Alabama
  - Daphne, Alabama, United States, 36526
    - Southern Cancer Center, 29653 Anchor Cross Blvd
  - Mobile, Alabama, United States, 36608
    - Souther Cancer Center, 3719 Dauphin St., 5 Floor
  - Mobile, Alabama, United States, 36608
    - Southern Cancer Center, 3 Mobile Infirmary Circle
  - Mobile, Alabama, United States, 36608
    - Southern Cancer Center, 6701 Airport Blvd., Bldg B, Terace Level
- Arizona
  - Phoenix, Arizona, United States, 85054
    - Mayo Clinic Hospital
  - Scottsdale, Arizona, United States, 85259
    - Mayo Clinic Hospital
- California
  - Alhambra, California, United States, 91801
    - UCLA Jonsson Comprehensive Cancer Center, 1411 S. Garfield Ave Suite 200
  - Burbank, California, United States, 91505
    - UCLA Jonsson Comprehensive Cancer Center, 201. S. Buena Vista St Suite 200
  - Laguna Hills, California, United States, 92653
    - UCLA Jonsson Comprehensive Cancer Center
  - Los Angeles, California, United States, 90095
    - UCLA Jonsson Comprehensive Cancer Center, 200 UCLA Medical Plaza
  - Pasadena, California, United States, 91105
    - UCLA Jonsson Comprehensive Cancer Center, 625 South Fair Oaks Avenue Suite 320
  - San Francisco, California, United States, 94115
    - University of California, San Francisco (UCSF) - Innovation, Technology & Alliances, 1600 Divisadero Street
  - Santa Monica, California, United States, 94115
    - UCLA Jonsson Comprehensive Cancer Center, 2020 Santa Monica Boulevard
- Colorado
  - Aurora, Colorado, United States, 80012-5405
    - Rocky Mountain Cancer Centers, 1700 South Potomac Street
  - Aurora, Colorado, United States, 80045
    - University of Colorado Hospital - Anschutz Cancer Pavilion, 1665 Aurora Court
  - Boulder, Colorado, United States, 80303
    - Rocky Mountain Cancer Centers, 4715 Arapahoe Ave
  - Colorado Springs, Colorado, United States, 80907
    - Rocky Mountain Cancer Centers, 2312 N. Nevada Avenue, Suite 400
  - Denver, Colorado, United States, 80218
    - Rocky Mountain Cancer Centers, 1800 Williams St.
  - Denver, Colorado, United States, 80220
    - Rocky Mountain Cancer Centers, 4700 E. Hale Parkway, Suite 400
  - Englewood, Colorado, United States, 80113
    - Rocky Mountain Cancer Centers, 499 E Hampden Ave Suite 450
  - Lakewood, Colorado, United States, 80228
    - Rocky Mountain Cancer Centers, 11750 West 2nd Place, Suite 1-100
  - Littleton, Colorado, United States, 80120
    - Rocky Mountain Cancer Centers, 22 West Dry Creek Circle
  - Lone Tree, Colorado, United States, 80124
    - Rocky Mountain Cancer Centers, 10103 Ridge Gate Parkway, Suite G-01
  - Longmont, Colorado, United States, 80501
    - Rocky Mountain Cancer Centers, 2030 W Mountain View Avenue, Ste. 210
  - Parker, Colorado, United States, 80138
    - Rocky Mountain Cancer Centers, 9397 Crown Crest Blvd., Suite 421
  - Pueblo, Colorado, United States, 81008
    - Rocky Mountain Cancer Centers, 3676 Parker Blvd., Suite 350
  - Thornton, Colorado, United States, 80260
    - Rocky Mountain Cancer Centers, 8820 Huron Street
- Connecticut
  - New Haven, Connecticut, United States, 06510-3206
    - Yale School of Medicine
  - Norwalk, Connecticut, United States, 06856
    - Norwalk Hospital, 34 Maple Street
- District of Columbia
  - Washington, District of Columbia, United States, 20007
    - Georgetown Lombardi Comprehensive Cancer Center
- Florida
  - Altamonte Springs, Florida, United States, 32701
    - Florida Cancer Specialists & Research Institute, 601 E. Altamonte Drive
  - Bonita Springs, Florida, United States, 34135
    - Florida Cancer Specialist
  - Bradenton, Florida, United States, 34209
    - Florida Cancer Specialists
  - Brandon, Florida, United States, 33511
    - Florida Cancer Specialists & Research Institute, 403 S. King Ave
  - Cape Coral, Florida, United States, 33914
    - Florida Cancer Specialists
  - Clearwater, Florida, United States, 33761
    - Florida Cancer Specialists & Research Institute, 3280 McMullen Booth road
  - Coral Gables, Florida, United States, 33146
    - Sylvester Comprehensive Cancer Center
  - Daytona Beach, Florida, United States, 32117
    - Florida Cancer Specialists & Research Institute, 224 Memorial medical Parway
  - Deerfield Beach, Florida, United States, 33442
    - Sylvester Comprehensive Cancer Center
  - Fort Myers, Florida, United States, 33905
    - Florida Cancer Specialists
  - Gainesville, Florida, United States, 32605
    - Florida Cancer Specialists & Research Institute, 6420 W Newberry Road Est Wing
  - Largo, Florida, United States, 33770
    - Florida Cancer Specialists & Research Institute, 100 Highland Avenue
  - Lecanto, Florida, United States, 34461
    - Florida Cancer Specialists & Research Institute, 521 N. Lecanto Highway
  - Miami, Florida, United States, 33136
    - Sylvester Comprehensive Cancer Center
  - Miami, Florida, United States, 33176
    - Baptist Health Medical Group Oncology, LLC
  - Naples, Florida, United States, 34102
    - Florida Cancer Specialists
  - New Port Richey, Florida, United States, 34655
    - Florida Cancer Specialists & Research Institute, 8763 River Crossing Blvd
  - Ocala, Florida, United States, 34471
    - Florida Cancer Specialists & Research Institute, 1630 SE 18th ST
  - Orange City, Florida, United States, 32763
    - Florida Cancer Specialists & Research Institute, 765 Image Way
  - Orlando, Florida, United States, 32806-2008
    - Orlando Regional Medical Center
  - Orlando, Florida, United States, 32806
    - Florida Cancer Specialists & Research Institute, 70 W Gore Street
  - Ormond Beach, Florida, United States, 32774
    - Florida Cancer Specialists & Research Institute - 325 Clyde Morris
  - Plantation, Florida, United States, 33324
    - Sylvester Comprehensive Cancer Center
  - Port Charlotte, Florida, United States, 33980
    - Florida Cancer Specialists
  - Saint Petersburg, Florida, United States, 33705-1449
    - Florida Cancer Specialists & Research Institute, 1201 Fifth Avenue North
  - Saint Petersburg, Florida, United States, 33705
    - Florida Cancer Specialists & Research Institute, 560 Jackson St
  - Sarasota, Florida, United States, 34236
    - Florida Cancer Specialists
  - Spring Hill, Florida, United States, 34608
    - Florida Cancer Specialists & Research Institute, 7154 Medical Center Drive
  - Tampa, Florida, United States, 33607
    - Florida Cancer Specialists & Research Institute, 3402 W Dr. Martin Luther King Jr Boulevard
  - Tavares, Florida, United States, 32778
    - Florida Cancer Specialists & Research Institute, 4100 Waterman Way
  - The Villages, Florida, United States, 32159
    - Florida Cancer Specialists & Research Institute, 1400 US highway 441 N
  - Venice, Florida, United States, 34285
    - Florida Cancer Specialists
  - Venice, Florida, United States, 34292
    - Florida Cancer Specialists
  - Vero Beach, Florida, United States, 32960
    - Florida Cancer Specialists & Research Institute - 3730 7th Terrace
  - Wellington, Florida, United States, 98374
    - Florida Cancer Specialists & Research Institute, 1037 State Road 7 Bldg B
  - West Palm Beach, Florida, United States, 33401-3406
    - Florida Cancer Specialists & Research Institute1309 N Flagler Dr
  - Winter Park, Florida, United States, 32792
    - Florida Cancer Specialists & Research Institute, 2100 Glenwood Drive
- Georgia
  - Alpharetta, Georgia, United States, 30005
    - Atlanta Cancer Center - Alpharetta
  - Athens, Georgia, United States, 30607
    - University Cancer & Blood Center, 3320 Old Jefferson Rd
  - Atlanta, Georgia, United States, 30342
    - Northside Hospital
  - Atlanta, Georgia, United States, 30342
    - Atlanta Cancer Care - Atlanta
  - Atlanta, Georgia, United States, 30341
    - GCS/Annex
  - Canton, Georgia, United States, 30114
    - GCS/Canton
  - Conyers, Georgia, United States, 30094
    - Atlanta Cancer Care - Conyers
  - Cumming, Georgia, United States, 30041
    - Atlanta Cancer Care - Cumming
  - Decatur, Georgia, United States, 30033
    - Atlanta Cancer Care - Decatur
  - Decatur, Georgia, United States, 30033
    - GCS/Stemmer
  - Jonesboro, Georgia, United States, 30236
    - Atlanta Cancer Care - Stockbridge
  - Macon, Georgia, United States, 31217
    - GCS/Macon
  - Marietta, Georgia, United States, 30060
    - GCS/Kennestone
  - Sandy Springs, Georgia, United States, 30342
    - GCS/Northside
- Illinois
  - Arlington Heights, Illinois, United States, 60005
    - Illinois Cancer Specialists
  - Chicago, Illinois, United States, 60637
    - University of Chicago Medical Center 5841 S. Maryland Ave
  - New Lenox, Illinois, United States, 60451
    - University of Chicago Comprehensive Cancer Center at Silver Cross Hospital 1900 Silver Cross Blvd
  - Niles, Illinois, United States, 60714-5905
    - Illinois Cancer Specialists
  - Orland Park, Illinois, United States, 60462
    - Orland Park - UCMC Center for Advanced Care 14290 South LaGrange Rd
- Kansas
  - Overland Park, Kansas, United States, 66209
    - MidAmerica Division Inc. c/o Menorah Medical Center
  - Westwood, Kansas, United States, 66205-2005
    - University of Kansas Cancer Center - The Richard and Annette Bloch Cancer Care Pavilion
- Maryland
  - Bethesda, Maryland, United States, 20817
    - Maryland Oncology Hematology
  - Brandywine, Maryland, United States, 20613
    - Maryland Oncology Hematology
  - Clinton, Maryland, United States, 20735
    - Maryland Oncology Hematology
  - Columbia, Maryland, United States, 21044
    - Maryland Oncology Hematology
  - Rockville, Maryland, United States, 20850
    - Maryland Oncology Hematology
  - Silver Spring, Maryland, United States, 20904
    - Maryland Oncology Hematology
  - Silver Spring, Maryland, United States, 20902
    - Maryland Oncology Hematology
- Massachusetts
  - Boston, Massachusetts, United States, 02114
    - Massachusetts General Hospital
  - Boston, Massachusetts, United States, 02114-2621
    - Dana-Farber Cancer Institute
  - Boston, Massachusetts, United States, 02215-5400
    - Beth Israel Deaconess Medical Center (BIDMC)
  - Danvers, Massachusetts, United States, 01923
    - Mass General - North Shore Cancer Center ( NSCC )
- Minnesota
  - Coon Rapids, Minnesota, United States, 55433
    - Mercy Hospital
  - Coon Rapids, Minnesota, United States, 55433
    - Minnesota Oncology Hematology P.A.
  - Coon Rapids, Minnesota, United States, 55433
    - Suburban Imaging Northwest
  - Coon Rapids, Minnesota, United States, 55433
    - Suburban Imaging
  - Fridley, Minnesota, United States, 55432
    - Mercy Hospital - Unity Campus AHL
  - Fridley, Minnesota, United States, 55432
    - Minnesota Oncology Hematology P.A.
  - Minneapolis, Minnesota, United States, 55404
    - Minnesota Oncology Hematology P.A.
  - Minneapolis, Minnesota, United States, 55407
    - Abbot Northwestern Hospital
  - Minneapolis, Minnesota, United States, 55407
    - Virginia G. Piper Cancer Center at HonorHealth
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic - 200 First Street SW
- Missouri
  - Creve Coeur, Missouri, United States, 63141
    - Washington University School of Medicine in St. Louis
  - Independence, Missouri, United States, 64057
    - MidAmerica Division Inc. c/o Menorah Medical Center
  - Kansas City, Missouri, United States, 64132
    - Research Medical Center
  - Saint Louis, Missouri, United States, 63110
    - Washington University School of Medicine in St. Louis
  - Saint Louis, Missouri, United States, 63129
    - Washington University School of Medicine in St. Louis
  - Saint Louis, Missouri, United States, 63136
    - Washington University School of Medicine in St. Louis
- Nebraska
  - Omaha, Nebraska, United States, 68114
    - Nebraska Cancer Specialists - Midwest Cancer Center - Papillion
  - Omaha, Nebraska, United States, 68130
    - Nebraska Cancer Specialists - Midwest Cancer Center - Paillion
  - Papillion, Nebraska, United States, 68046-5706
    - Nebraska Cancer Specialists- Midwest Cancer Center- Papillion
- New Jersey
  - New Brunswick, New Jersey, United States, 08903
    - Rutgers Cancer Institute of New Jersey
- New York
  - Albany, New York, United States, 12206
    - New York Oncology Hematology, P.C.
  - Clifton Park, New York, United States, 12065
    - New York Oncology Hematology, P.C.
  - East Setauket, New York, United States, 11733
    - North Shore Hematology Oncology Associates., PC, 235 North Belle Mead Road
  - New York, New York, United States, 10032
    - Columbia University Medical Center
  - New York, New York, United States, 10065
    - Memorial Sloan Kettering Cancer Center
  - Patchogue, New York, United States, 11772
    - North Shore Hematology Oncology Associates., PC, 285 Sills Road Building 16
- North Carolina
  - Chapel Hill, North Carolina, United States, 27599
    - UNC Health Care System
- Ohio
  - Columbus, Ohio, United States, 432100
    - The Ohio State University Wexner Medical Center, 460 W 10th Ave
  - Columbus, Ohio, United States, 43212
    - The Ohio State University Wexner Medical Center, 1145 Olentangy River Road
- Oregon
  - Portland, Oregon, United States, 97213
    - Providence Medical Group
- Pennsylvania
  - Greensburg, Pennsylvania, United States, 15601
    - UPMC Hillman Cancer Center Mountainview Arnold Palmer Pavilion
  - Monroeville, Pennsylvania, United States, 15146
    - UPMC Hillman Cancer Center UPMC East
  - Pittsburgh, Pennsylvania, United States, 15213
    - Magee-Womens Hospital of UPMC
  - Pittsburgh, Pennsylvania, United States, 15102
    - UPMC Hillman Cancer Center Upper Saint Clair
  - Pittsburgh, Pennsylvania, United States, 15212
    - Allegheny-Singer Research Institute, 320 East North Avenue
  - Pittsburgh, Pennsylvania, United States, 15237
    - UPMC Hillman Cancer Center UPMC Passavant
- Tennessee
  - Chattanooga, Tennessee, United States, 37404-1108
    - Tennessee Oncology - Chattanooga Oncology & Hematology Associates
  - Chattanooga, Tennessee, United States, 37404
    - Tennesee Oncology - PLLC
  - Cleveland, Tennessee, United States, 37311
    - Tenesse Oncology - PLLC
  - Dickson, Tennessee, United States, 37055
    - Tennessee Oncology, LLC
  - Franklin, Tennessee, United States, 37067
    - Tennessee Ocology, LLC
  - Gallatin, Tennessee, United States, 37066
    - Tennessee Oncology, LLC
  - Germantown, Tennessee, United States, 28138
    - West Cancer Center, 7945 Wolf River Blvd
  - Hermitage, Tennessee, United States, 37076
    - Tennessee Oncology, LLC
  - Lebanon, Tennessee, United States, 37090
    - Tennessee Oncology, LLC
  - Murfreesboro, Tennessee, United States, 37129
    - Tennessee Oncology, LLC
  - Nashville, Tennessee, United States, 37232
    - Vanderbilt-Ingram Cancer Center
  - Nashville, Tennessee, United States, 37203
    - Sarah Cannon Cancer Institute/Tennessee Oncology
  - Nashville, Tennessee, United States, 37203
    - Tennessee Oncology, LLC
  - Nashville, Tennessee, United States, 37204
    - Vanderbilt Breast Cancer Center at One Hundred Oaks 719 Thompson Lane, Suite 25000
  - Nashville, Tennessee, United States, 37205
    - Tennessee Ocology, LLC
  - Nashville, Tennessee, United States, 37207
    - Tennessee Oncology, LLC
  - Nashville, Tennessee, United States, 37211
    - Tenessee Oncology
  - Nashville, Tennessee, United States, 37232
    - Henry-Joyce Cancer Clinic 1301 Medical Center Drive 1903 The Vanderbilt Clinic Nashville, TN 37232
  - Shelbyville, Tennessee, United States, 37160
    - Tennessee Oncology, LLC
- Texas
  - Arlington, Texas, United States, 76014
    - Center for Cancer and Blood Disorders
  - Burleson, Texas, United States, 76028
    - Center for Cancer and Blood Disorders
  - Dallas, Texas, United States, 75230-6899
    - Texas Oncology- Medical City Dallas Building D
  - Dallas, Texas, United States, 75246-2006
    - Texas Oncology - Baylor Charles A. Sammons Cancer Center
  - Denton, Texas, United States, 76210
    - Texas Oncology
  - Fort Worth, Texas, United States, 76104-4611
    - Center for Cancer and Blood Disorders
  - Houston, Texas, United States, 77030
    - Houston Methodist Hospital - 6565 Fannin St
  - Longview, Texas, United States, 75601
    - Texas Oncology-Longview Cancer Center
  - Plano, Texas, United States, 75075-7753
    - Texas Oncology
  - Tyler, Texas, United States, 75702
    - US Oncology
  - Weatherford, Texas, United States, 76086
    - Center for Cancer and Blood Disorders
- Virginia
  - Alexandria, Virginia, United States, 22304
    - Virginia Cancer Specialists, PC
  - Arlington, Virginia, United States, 22205
    - Virginia Cancer Specialists, PC
  - Blacksburg, Virginia, United States, 24060
    - Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
  - Chesapeake, Virginia, United States, 23320
    - Virginia Oncology Associates
  - Fairfax, Virginia, United States, 22031-4629
    - Virginia Cancer Specialists, PC
  - Gainesville, Virginia, United States, 20155
    - Virginia Cancer Specialists, PC
  - Hampton, Virginia, United States, 23666
    - Virginia Oncology Associates
  - Leesburg, Virginia, United States, 20176
    - Virginia Cancer Specialists, PC
  - Low Moor, Virginia, United States, 24457
    - Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
  - Newport News, Virginia, United States, 23606
    - Virginia Oncology Associates
  - Norfolk, Virginia, United States, 23502-0026
    - Virginia Oncology Associates, P.C.
  - Roanoke, Virginia, United States, 24014
    - Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
  - Salem, Virginia, United States, 24153
    - Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
  - Virginia Beach, Virginia, United States, 23456
    - Virginia Oncology Associates
  - Woodbridge, Virginia, United States, 22191
    - Virginia Cancer Specialists, PC
  - Wytheville, Virginia, United States, 24382
    - Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
- Washington
  - Edmonds, Washington, United States, 98026
    - Swedish Cancer Institute
  - Issaquah, Washington, United States, 98029
    - Swedish Cancer Institute
  - Seattle, Washington, United States, 98104
    - Swedish Cancer Institute
  - Seattle, Washington, United States, 98122
    - Swedish Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sacituzumab Govitecan Participants 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).	Drug: Sacituzumab govitecan 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. Other Names: IMMU-132 Trodelvy®
Active Comparator: Treatment of Physician's Choice (TPC) Participants 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.	Drug: Eribulin 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). Other Names: Halaven Drug: Capecitabine 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. Other Names: Xeloda Drug: Gemcitabine 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. Other Names: Gemzar Drug: Vinorelbine 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. Other Names: Navelbine

Participant Group / Arm

Intervention / Treatment

Experimental: Sacituzumab Govitecan

Participants 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).

Drug: Sacituzumab govitecan

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.

Other Names:

IMMU-132
Trodelvy®

Active Comparator: Treatment of Physician's Choice (TPC)

Participants 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.

Drug: Eribulin

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).

Other Names:

Halaven

Drug: Capecitabine

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.

Other Names:

Xeloda

Drug: Gemcitabine

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.

Other Names:

Gemzar

Drug: Vinorelbine

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.

Other Names:

Navelbine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS) by IRC Assessment in the ITT 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)	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.	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 Time Frame: From the randomization to death from any cause (maximum follow-up duration: 30.8 months)	Overall survival (OS) was defined as the time from the randomization to death from any cause. OS was estimated using Kaplan-Meier estimate.	From the randomization to death from any cause (maximum follow-up duration: 30.8 months)
Overall Survival (OS) in ITT Population Time Frame: From the randomization to death from any cause (maximum follow-up duration: 30.8 months)	Overall survival (OS) was defined as the time from the randomization to death from any cause. OS was estimated using Kaplan-Meier estimate.	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 Time Frame: 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)	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.	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 Time Frame: 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)	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.	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)
Time to Objective Response by the IRC Assessment in BM-ve Population Time Frame: 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)	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.	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)
Duration of Response (DOR) by IRC and Investigator Assessment in BM-ve Population Time Frame: 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)	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.	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)
Time to Progression (TTP) by Investigator Assessment in BM-ve Population Time Frame: 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)	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.	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)
Time to Progression (TTP) by IRC Assessment in BM-ve Population Time Frame: 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)	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.	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)
Clinical Benefit Rate (CBR) by IRC and Investigator Assessment in BM-ve Population Time Frame: 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)	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.	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)
Percentage of Participants Experiencing Any Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation of Study Drug Time Frame: First dose date up to last follow-up (maximum up to 30.8 months)	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	First dose date up to last follow-up (maximum up to 30.8 months)
Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ-C30) Score Time Frame: Baseline; End of Treatment (EOT) (up to 29.6 months)	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.	Baseline; End of Treatment (EOT) (up to 29.6 months)
Percentage of Participants Experiencing the Worst Laboratory Abnormalities Grade 3 or 4 Post-Baseline Time Frame: First dose date up to last follow-up (maximum up to 30.8 months)	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.	First dose date up to last follow-up (maximum up to 30.8 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
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.
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
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.
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.
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, Cortés J, O'Shaughnessy J, Diéras 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.
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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2017

Primary Completion (Actual)

March 30, 2020

Study Completion (Actual)

December 8, 2020

Study Registration Dates

First Submitted

October 8, 2015

First Submitted That Met QC Criteria

October 9, 2015

First Posted (Estimate)

October 12, 2015

Study Record Updates

Last Update Posted (Actual)

June 15, 2022

Last Update Submitted That Met QC Criteria

May 26, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

IMMU-132-05
2017-003019-21 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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/

IPD Sharing Time Frame

18 months after study completion

IPD Sharing Access Criteria

A secured external environment with username, password, and RSA code.

IPD Sharing Supporting Information Type

Study Protocol
Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Breast Cancer

Clinical Trials on Sacituzumab govitecan

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