Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02574455
Recruitment Status : Active, not recruiting
First Posted : October 12, 2015
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Immunomedics, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Drug: Sacituzumab govitecan Drug: Eribulin Drug: Capecitabine Drug: Gemcitabine Drug: Vinorelbine Phase 3

Detailed Description:

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.

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 progression-free survival (PFS) in patients with metastatic TNBC previously treated with at least two systemic chemotherapy regimens.

The secondary objectives of the study are to compare between the two treatment groups for:

  • Overall Survival (OS)
  • Independently-determined Objective Response Rate (ORR), duration of response and time to onset of response per RECIST 1.1 criteria
  • Quality of life
  • Safety (adverse events, safety laboratories, incidence of dose delays and dose reductions, treatment discontinuations due to adverse events) Exploratory objectives include exposure-response analysis for the efficacy (PFS and OS) and safety (incidence of Grade 3-5 adverse events, related to UGT1A1 endpoints).

Four-Hundred and eighty-eight patients are anticipated to be enrolled. Approximately 150 institutions will participate in this study, including sites in North America and Europe.

Clinical sites will use standard ASCO/CAP criteria for the pathological diagnosis of TNBC, defined as negative for estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER2). Receptor results will be based on local assessment. TNBC status will be reviewed centrally but these results are not required prior to determining eligibility.

BRCA 1&2 mutational status will be collected, if known. Baseline serum biomarkers (CA15-3, CA27-29, and CEA) will be measured. A single whole-blood sample will be also collected from all patients for determination of UGT1A1 genotype for retrospective assessment predicting of toxicity.

The Sponsor will request slides from prior (archived) biopsy or surgical specimens, particularly for immunohistology documentation of tumor Trop-2 expression and other appropriate tumor markers, including topoisomerase 1.

Patients meeting eligibility will be randomized 1:1 to receive either sacituzumab govitecan or treatment of physician choice (TPC), which needs to be selected prior to randomization from one of the 4 allowed regimens. Randomization will be stratified by number of prior chemotherapies for advanced disease (2-3 vs > 3) and geographical location (North America vs Europe).

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.

No crossover to sacituzumab govitecan treatment will be allowed after discontinuing treatment in the TPC arm, but otherwise there is no restriction on subsequent therapies that a patient may receive after discontinuing the study.

All patients, including those prematurely terminating study participation, will be followed every 4 weeks for survival follow-up.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 529 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Study of Sacituzumab Govitecan (IMMU-132) in Refractory/Relapsed Triple-Negative Breast Cancer
Actual Study Start Date : October 12, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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)
Other Name: IMMU-132

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: Eribulin
Eribulin (1.4 mg/m2 IV on Days 1 and 8 of a 21-day cycle) See section 6.5.1
Other Name: Halaven

Drug: Capecitabine
Capecitabine (1000-1250 mg/m2 orally twice daily on Days 1-14 of a 21-day cycle) See section 6.5.2
Other Name: Xeloda

Drug: Gemcitabine
Gemcitabine (800-1200 mg/m2 IV on Days 1, 8 and 15 of a 28-day cycle). See section 6.5.3
Other Name: Gemzar

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).
Other Name: Navelbine




Primary Outcome Measures :
  1. Progression-Free Survival (PFS): [ Time Frame: 3 YEARS ]
    PFS


Secondary Outcome Measures :
  1. Overall Survival (OS): [ Time Frame: 3 YEARS ]

    OS will compared between the two treatment groups.

    PFS will be measured by an independent centralized and blinded group of radiology experts who will be assessing tumor response using RECIST 1.1 criteria. FDA definitions and guidance as described in Guidance for Industry:


  2. Objective Response Rate [ Time Frame: 3 years ]
    ORR will compared between the two treatment groups.

  3. Duration of Response [ Time Frame: 3 years ]
    Duration of response will compared between the two treatment groups.

  4. Time to Onset of response [ Time Frame: 3 years ]
    Time to onset of response will compared between the two treatment groups.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02574455


  Hide Study Locations
Locations
Layout table for location information
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
Colchester Hospital University NHS Foundation Trust - Colchester General Hospital, Turner Road
Colchester, ESS, United Kingdom, C04 5JL
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.
Investigators
Layout table for investigator information
Study Chair: William Wegener, MD,PhD Immunomedics, Inc.

Layout table for additonal information
Responsible Party: Immunomedics, Inc.
ClinicalTrials.gov Identifier: NCT02574455     History of Changes
Other Study ID Numbers: IMMU-132-05
First Posted: October 12, 2015    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Capecitabine
Vinorelbine
Camptothecin
Immunoconjugates
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Topoisomerase I Inhibitors
Topoisomerase Inhibitors