Clinical Trial - NCT02574455

ASCENT-Study of Sacituzumab Govitecan in Refractory/Relapsed Triple-Negative Breast Cancer

Active, not recruiting

Sponsor: Immunomedics, Inc.

Collaborators:

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT02574455

Protocol Info

Short Description: ASCENT-Study of Sacituzumab Govitecan in Refractory/Relapsed Triple-Negative Breast Cancer
Long Description: 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
MGH Status: Closed
Sponsor: Immunomedics
Disease Program: Breast

Next Steps


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Purpose

This is an international, multi-center, open-label, randomized, Phase III study in patients with metastatic TNBC refractory or relapsing after at least 2 prior chemotherapies (including a taxane) for their metastatic disease. Patients meeting eligibility will be randomized 1:1 to receive either sacituzumab govitecan or treatment of physician choice (TPC) Patients will be treated until progression, unacceptable toxicity, study withdrawal, or death, whichever comes first. Tumor progression leading to treatment withdrawal will be assessed by the investigator. Starting with the initial dose of sacituzumab govitecan or TPC, Imaging assessments will be obtained at least every 8 weeks until the occurrence of progression of disease requiring discontinuation of further treatment. All patients, will be followed every 4 weeks during the first year and every 8 weeks thereafter for survival follow-up.
Condition Title Intervention Phase
Breast Cancer Sacituzumab govitecan Eribulin Capecitabine Gemcitabine Vinorelbine Phase 3
Study Type Interventional
Official Title Phase III Study of Sacituzumab Govitecan (IMMU-132) in Refractory/Relapsed Triple-Negative Breast Cancer

Primary Outcome Measures

Progression-Free Survival (PFS): [Time Frame: 3 YEARS] [Designated as safety issue: ]


Secondary Outcome Measures

Overall Survival (OS): [Time Frame: 3 YEARS] [Designated as safety issue: ]

Objective Response Rate [Time Frame: 3 years] [Designated as safety issue: ]

Duration of Response [Time Frame: 3 years] [Designated as safety issue: ]

Time to Onset of response [Time Frame: 3 years] [Designated as safety issue: ]

Estimated Enrollment: 529
Study Start Date: November 2017
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: April 2020
Arms Assigned Interventions

Experimental:IMMU-132

Sacituzumab govitecan (10 mg/kg on Days 1 and 8 of 21-day cycles)
Drug:Sacituzumab govitecan
Sacituzumab govitecan (10 mg/kg on Days 1 and 8 of 21-day cycles)

Active Comparator:Control Arm

Treatment of Physician's Choice determined before randomization from only one of the following treatments (see Appendix 2 for more details on administration and dosing management): Eribulin (1.4 mg/m2 IV on Days 1 and 8 of a 21-day cycle). See section 6.5.1 Capecitabine (1000-1250 mg/m2 orally twice daily on Days1-14 of a 21-day cycle). See section 6.5.2 Gemcitabine (800-1200 mg/m2 IV on Days 1, 8 and 15 of a 28-day cycle). See section 6.5.3 Vinorelbine (25 mg/m2 weekly IV on Day 1 weekly) See section 6.5.4 (Note: eligible patients with Grade 2 neuropathy should not be prescribed vinorelbine as TPC)
Drug:Vinorelbine
Vinorelbine (25 mg/m2 IV on Day 1 weekly). See section 6.5.4 (Note: eligible patients with Grade 2 neuropathy should not be prescribed vinorelbine as TPC).

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

Inclusion Criteria:

  • Female or male patients, >18 years of age, able to understand and give written informed consent.
  • Histologically or cytologically confirmed TNBC based on the most recent analyzed biopsy or other pathology specimen. TNBC determination as per local institution as per standard guidelines.
  • Refractory to or relapsed after at least two prior standard therapeutic regimens for advanced/metastatic TNBC.
  • Prior exposure to a taxane (paclitaxel or docetaxel)-based regimen 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.
  • ECOG performance score of 0 or 1 .
  • Measurable disease by CT or MRI as per RECIST 1.1. Bone-only disease is not permitted.
  • At least 2 weeks beyond prior treatment (chemotherapy, investigational drugs including small molecular inhibitors, endocrine therapy, immunotherapy and/or radiation therapy) 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).
  • Adequate hematology without ongoing transfusional support (hemoglobin > 9 g/dL, ANC > 1,500 per mm3, platelets > 100,000 per mm3).
  • Adequate renal and hepatic function (creatinine = 2.0 x IULN, bilirubin = 1.5 IULN, AST and ALT = 3.0 x IULN or 5 x IULN if known liver metastases).
  • Otherwise, all toxicity at study entry < Grade 1 by NCI CTCAE v4.00 (Patients with = Grade 2 neuropathy are eligible).
  • Patients 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.

Exclusion Criteria:

  • Women who are pregnant or lactating.
  • Women of childbearing potential or fertile men unwilling to use effective contraception during study until conclusion of 4-week post-treatment evaluation period.
  • Patients with Gilbert's disease.
  • Patients with active = grade 2 anorexia, nausea or vomiting, and/or signs of intestinal obstruction.
  • Patients with non-melanoma skin cancer or carcinoma in situ of the cervix are eligible, while patients with other prior malignancies must have had at least a 3-year disease-free interval.
  • Patients known to be HIV positive, hepatitis B positive, or hepatitis C positive.
  • Infection requiring intravenous antibiotic use within one week of enrollment.
  • Patients with a history of an anaphylactic reaction to irinotecan.
  • 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT02574455

Locations

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

Sponsors and Collaborators

Immunomedics, Inc.

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT02574455
Other Study ID Numbers:
Study First Received:
Last Updated:
Health Authority:

Additional relevant MeSH terms:

Breast Neoplasms

Triple Negative Breast Neoplasms

Gemcitabine

Capecitabine

Vinorelbine

Camptothecin

Immunoconjugates

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on April 09, 2020