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Trial record 1 of 4 for:    sacituzumab govitecan | Breast Cancer
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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02574455
Recruitment Status : Recruiting
First Posted : October 12, 2015
Last Update Posted : April 8, 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 488 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.


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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


Contacts
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Contact: Medical Information 888-983-4668 medinfo@immunomedics.com

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Locations
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United States, Alabama
Southern Cancer Center, 29653 Anchor Cross Blvd Active, not recruiting
Daphne, Alabama, United States, 36526
Souther Cancer Center, 3719 Dauphin St., 5 Floor Active, not recruiting
Mobile, Alabama, United States, 36608
Southern Cancer Center, 3 Mobile Infirmary Circle Active, not recruiting
Mobile, Alabama, United States, 36608
Southern Cancer Center, 6701 Airport Blvd., Bldg B, Terace Level Active, not recruiting
Mobile, Alabama, United States, 36608
United States, Arizona
Mayo Clinic Hospital Active, not recruiting
Phoenix, Arizona, United States, 85054
Mayo Clinic Hospital Active, not recruiting
Scottsdale, Arizona, United States, 85259
United States, California
UCLA Jonsson Comprehensive Cancer Center, 1411 S. Garfield Ave Suite 200 Recruiting
Alhambra, California, United States, 91801
Contact: Monica Rocha    310-582-6324    mprocha@mednet.ucla.edu   
Principal Investigator: Sarah Hurvitz, MD         
UCLA Jonsson Comprehensive Cancer Center, 201. S. Buena Vista St Suite 200 Recruiting
Burbank, California, United States, 91505
Contact: Monica Rocha    310-582-6324    mprocha@mednet.ucla.edu   
Principal Investigator: Sarah Hurvitz, MD         
UCLA Jonsson Comprehensive Cancer Center Recruiting
Laguna Hills, California, United States, 92653
Contact: Monica Rocha    310-582-6324    mprocha@mednet.ucla.edu   
Principal Investigator: Sara Hurvitz, MD         
UCLA Jonsson Comprehensive Cancer Center, 200 UCLA Medical Plaza Recruiting
Los Angeles, California, United States, 90095
Contact: Monica Rocha    310-582-6324    mprocha@mednet.ucla.edu   
Principal Investigator: Sarah Hurvitz, MD         
UCLA Jonsson Comprehensive Cancer Center, 625 South Fair Oaks Avenue Suite 320 Recruiting
Pasadena, California, United States, 91105
Contact: Monica Rocha    310-582-6324    mprocha@mednet.ucla.edu   
Principal Investigator: Sara Hurvitz, MD         
University of California, San Francisco (UCSF) - Innovation, Technology & Alliances, 1600 Divisadero Street Active, not recruiting
San Francisco, California, United States, 94115
UCLA Jonsson Comprehensive Cancer Center, 2020 Santa Monica Boulevard Recruiting
Santa Monica, California, United States, 94115
Contact: Monica Rocha    310-582-6324    mprocha@mednet.ucla.edu   
Principal Investigator: Sara Hurvitz, MD         
United States, Colorado
Rocky Mountain Cancer Centers, 1700 South Potomac Street Active, not recruiting
Aurora, Colorado, United States, 80012-5405
University of Colorado Hospital - Anschutz Cancer Pavilion, 1665 Aurora Court Recruiting
Aurora, Colorado, United States, 80045
Contact: Jonathan Scheiner    720-848-0719    jonathan.scheiner@ucdenver.edu   
Principal Investigator: Jennifer Diamond, MD         
Rocky Mountain Cancer Centers, 4715 Arapahoe Ave Active, not recruiting
Boulder, Colorado, United States, 80303
Rocky Mountain Cancer Centers, 2312 N. Nevada Avenue, Suite 400 Active, not recruiting
Colorado Springs, Colorado, United States, 80907
Rocky Mountain Cancer Centers, 1800 Williams St. Active, not recruiting
Denver, Colorado, United States, 80218
Rocky Mountain Cancer Centers, 4700 E. Hale Parkway, Suite 400 Active, not recruiting
Denver, Colorado, United States, 80220
Rocky Mountain Cancer Centers, 499 E Hampden Ave Suite 450 Active, not recruiting
Englewood, Colorado, United States, 80113
Rocky Mountain Cancer Centers, 11750 West 2nd Place, Suite 1-100 Active, not recruiting
Lakewood, Colorado, United States, 80228
Rocky Mountain Cancer Centers, 22 West Dry Creek Circle Active, not recruiting
Littleton, Colorado, United States, 80120
Rocky Mountain Cancer Centers, 10103 Ridge Gate Parkway, Suite G-01 Active, not recruiting
Lone Tree, Colorado, United States, 80124
Rocky Mountain Cancer Centers, 2030 W Mountain View Avenue, Ste. 210 Active, not recruiting
Longmont, Colorado, United States, 80501
Rocky Mountain Cancer Centers, 9397 Crown Crest Blvd., Suite 421 Active, not recruiting
Parker, Colorado, United States, 80138
Rocky Mountain Cancer Centers, 3676 Parker Blvd., Suite 350 Active, not recruiting
Pueblo, Colorado, United States, 81008
Rocky Mountain Cancer Centers, 8820 Huron Street Active, not recruiting
Thornton, Colorado, United States, 80260
United States, Connecticut
Yale School Of Medicine Active, not recruiting
New Haven, Connecticut, United States, 06510-3206
Norwalk Hospital, 34 Maple Street Recruiting
Norwalk, Connecticut, United States, 06856
Contact: Jennifer Long    203-852-2996    Jennifer.Long@wchn.org   
Principal Investigator: Linda Vahdat, MD         
United States, District of Columbia
Georgetown Lombardi Comprehensive Cancer Center Recruiting
Washington, District of Columbia, United States, 20007
Contact: Julie Castle    202-687-2209    bickmorj@georgetown.edu   
United States, Florida
Florida Cancer Specialists & Research Institute, 601 E. Altamonte Drive Active, not recruiting
Altamonte Springs, Florida, United States, 32701
Florida Cancer Specialist Active, not recruiting
Bonita Springs, Florida, United States, 34135
Florida Cancer Specialists Active, not recruiting
Bradenton, Florida, United States, 34209
Florida Cancer Specialists & Research Institute, 403 S. King Ave Active, not recruiting
Brandon, Florida, United States, 33511
Florida Cancer Specialists Active, not recruiting
Cape Coral, Florida, United States, 33914
Florida Cancer Specialists & Research Institute, 3280 McMullen Booth road Active, not recruiting
Clearwater, Florida, United States, 33761
Sylvester Comprehensive Cancer Center Active, not recruiting
Coral Gables, Florida, United States, 33146
Florida Cancer Specialists & Research Institute, 224 Memorial medical Parway Recruiting
Daytona Beach, Florida, United States, 32117
Contact: Jenifer Bar-Nur    561-472-1696    JBar-nur@flcancer.com   
Principal Investigator: Robert Weaver, MD         
Sylvester Comprehensive Cancer Center Active, not recruiting
Deerfield Beach, Florida, United States, 33442
Florida Cancer Specialists Active, not recruiting
Fort Myers, Florida, United States, 33905
Florida Cancer Specialists & Research Institute, 6420 W Newberry Road Est Wing Active, not recruiting
Gainesville, Florida, United States, 32605
Florida Cancer Specialists & Research Institute, 100 Highland Avenue Active, not recruiting
Largo, Florida, United States, 33770
Florida Cancer Specialists & Research Institute, 521 N. Lecanto Highway Active, not recruiting
Lecanto, Florida, United States, 34461
Sylvester Comprehensive Cancer Center Active, not recruiting
Miami, Florida, United States, 33136
Baptist Health Medical Group Oncology, LLC Recruiting
Miami, Florida, United States, 33176
Contact: Sandino Danieska    786-596-7710    DanieskaS@baptisthealth.net   
Florida Cancer Specialists Active, not recruiting
Naples, Florida, United States, 34102
Florida Cancer Specialists & Research Institute, 8763 River Crossing Blvd Active, not recruiting
New Port Richey, Florida, United States, 34655
Florida Cancer Specialists & Research Institute, 1630 SE 18th ST Active, not recruiting
Ocala, Florida, United States, 34471
Florida Cancer Specialists & Research Institute, 765 Image Way Active, not recruiting
Orange City, Florida, United States, 32763
Orlando Regional Medical Center Active, not recruiting
Orlando, Florida, United States, 32806-2008
Florida Cancer Specialists & Research Institute, 70 W Gore Street Active, not recruiting
Orlando, Florida, United States, 32806
Florida Cancer Specialists & Research Institute - 325 Clyde Morris Recruiting
Ormond Beach, Florida, United States, 32774
Contact: Jennifer Bar-Nur    561-472-1696    jbar-nur@flcancer.com   
Sylvester Comprehensive Cancer Center Active, not recruiting
Plantation, Florida, United States, 33324
Florida Cancer Specialists Active, not recruiting
Port Charlotte, Florida, United States, 33980
Florida Cancer Specialists & Research Institute, 1201 Fifth Avenue North Active, not recruiting
Saint Petersburg, Florida, United States, 33705-1449
Florida Cancer Specialists & Research Institute, 560 Jackson St Active, not recruiting
Saint Petersburg, Florida, United States, 33705
Florida Cancer Specialists Active, not recruiting
Sarasota, Florida, United States, 34236
Florida Cancer Specialists & Research Institute, 7154 Medical Center Drive Active, not recruiting
Spring Hill, Florida, United States, 34608
Florida Cancer Specialists & Research Institute, 3402 W Dr. Martin Luther King Jr Boulevard Active, not recruiting
Tampa, Florida, United States, 33607
Florida Cancer Specialists & Research Institute, 4100 Waterman Way Active, not recruiting
Tavares, Florida, United States, 32778
Florida Cancer Specialists & Research Institute, 1400 US highway 441 N Active, not recruiting
The Villages, Florida, United States, 32159
Florida Cancer Specialists Active, not recruiting
Venice, Florida, United States, 34285
Florida Cancer Specialists Active, not recruiting
Venice, Florida, United States, 34292
Florida Cancer Specialists & Research Institute - 3730 7th Terrace Recruiting
Vero Beach, Florida, United States, 32960
Contact: Jennifer Bar-Nur    561-472-1696    jbar-nur@flcancer.com   
Florida Cancer Specialists & Research Institute, 1037 State Road 7 Bldg B Recruiting
Wellington, Florida, United States, 98374
Contact: Jenifer Bar-Nur    561-472-1696    JBar-nur@flcancer.com   
Principal Investigator: Robert Weaver, MD         
Florida Cancer Specialists & Research Institute1309 N Flagler Dr Recruiting
West Palm Beach, Florida, United States, 33401-3406
Contact: Jenifer Bar-Nur    561-472-1696    JBar-nur@flcancer.com   
Principal Investigator: Robert Weaver, MD         
Florida Cancer Specialists & Research Institute, 2100 Glenwood Drive Active, not recruiting
Winter Park, Florida, United States, 32792
United States, Georgia
Atlanta Cancer Center - Alpharetta Recruiting
Alpharetta, Georgia, United States, 30005
Contact: Sally Haislip    770-496-9457    Sally.Haislip@gacancer.com   
University Cancer & Blood Center, 3320 Old Jefferson Rd Recruiting
Athens, Georgia, United States, 30607
Contact: Jamie Hodgson    706-353-2990 ext 279    jhodgson@universitycancer.com   
Principal Investigator: Petros Nikolinakos, MD         
GCS/Annex Recruiting
Atlanta, Georgia, United States, 30341
Contact: Sally Haislip    770-496-9457    Sally.Haislip@gacancer.com   
Atlanta Cancer Care - Atlanta Recruiting
Atlanta, Georgia, United States, 30342
Contact: Sally Haislip    770-496-9457    Sally.Haislip@gacancer.com   
Northside Hospital Recruiting
Atlanta, Georgia, United States, 30342
Contact: Sally Haislap    770-496-9457    sally.haislip@gacancer.com   
GCS/Canton Recruiting
Canton, Georgia, United States, 30114
Contact: Sally Haislip    770-496-9457    Sally.Haislip@gacancer.com   
Atlanta Cancer Care - Conyers Recruiting
Conyers, Georgia, United States, 30094
Contact: Sally Haislip    770-496-9457    Sally.Haislip@gacancer.com   
Atlanta Cancer Care - Cumming Recruiting
Cumming, Georgia, United States, 30041
Contact: Sally Haislip    770-496-9457    Sally.Haislip@gacancer.com   
Atlanta Cancer Care - Decatur Recruiting
Decatur, Georgia, United States, 30033
Contact: Sally Haislip    770-496-9457    Sally.Haislip@gacancer.com   
GCS/Stemmer Recruiting
Decatur, Georgia, United States, 30033
Contact: Sally Haislip    770-496-9547    Sally.Haislip@gacancer.com   
Atlanta Cancer Care - Stockbridge Recruiting
Jonesboro, Georgia, United States, 30236
Contact: Sally Haislip    770-496-9457    Sally.Haislip@gacancer.com   
GCS/Macon Recruiting
Macon, Georgia, United States, 31217
Contact: Sally Haislip    770-496-9457    Sally.Haislip@gacancer.com   
GCS/Kennestone Recruiting
Marietta, Georgia, United States, 30060
Contact: Sally Haislip    770-496-9457    Sally.Haislip@gacancer.com   
GCS/Northside Recruiting
Sandy Springs, Georgia, United States, 30342
Contact: Sally Haislip    770-496-9457    Sally.Haislip@gacancer.com   
United States, Illinois
Illinois Cancer Specialists Active, not recruiting
Arlington Heights, Illinois, United States, 60005
The University of Chicago Medical Center Active, not recruiting
Chicago, Illinois, United States, 60637
University of Chicago Medical Center 5841 S. Maryland Ave Active, not recruiting
Chicago, Illinois, United States, 60637
University of Chicago Comprehensive Cancer Center at Silver Cross Hospital 1900 Silver Cross Blvd Active, not recruiting
New Lenox, Illinois, United States, 60451
Illinois Cancer Specialists Active, not recruiting
Niles, Illinois, United States, 60714-5905
Orland Park - UCMC Center for Advanced Care 14290 South LaGrange Rd Active, not recruiting
Orland Park, Illinois, United States, 60462
United States, Kansas
MidAmerica Division Inc. c/o Menorah Medical Center Active, not recruiting
Overland Park, Kansas, United States, 66209
University of Kansas Cancer Center - The Richard and Annette Bloch Cancer Care Pavilion Recruiting
Westwood, Kansas, United States, 66205-2005
United States, Maryland
Maryland Oncology Hematology Active, not recruiting
Bethesda, Maryland, United States, 20817
Maryland Oncology Hematology Active, not recruiting
Brandywine, Maryland, United States, 20613
Maryland Oncology Hematology Active, not recruiting
Clinton, Maryland, United States, 20735
Maryland Oncology Hematology Active, not recruiting
Columbia, Maryland, United States, 21044
Maryland Oncology Hematology Active, not recruiting
Rockville, Maryland, United States, 20850
Maryland Oncology Hematology Active, not recruiting
Silver Spring, Maryland, United States, 20902
Maryland Oncology Hematology Active, not recruiting
Silver Spring, Maryland, United States, 20904
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02114-2621
Contact: Alyssa Savarino    617-643-4732    alsavarino@mgh.harvard.edu   
Principal Investigator: Aditya Bardia         
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Alyssa Savarino    617-643-4732    alsavarino@mgh.harvard.edu   
Principal Investigator: Aditya Bardia         
Beth Israel Deaconess Medical Center (BIDMC) Recruiting
Boston, Massachusetts, United States, 02215-5400
Contact: Alyssa Savarino    617-643-4732    alsavarino@mgh.harvard.edu   
Principal Investigator: Aditya Bardia         
Mass General - North Shore Cancer Center ( NSCC ) Recruiting
Danvers, Massachusetts, United States, 01923
Contact: Alyssa Savarino    617-643-4732    alsavarino@mgh.harvard.edu   
United States, Minnesota
Mercy Hospital Active, not recruiting
Coon Rapids, Minnesota, United States, 55433
Minnesota Oncology Hematology P.A. Active, not recruiting
Coon Rapids, Minnesota, United States, 55433
Suburban Imaging Northwest Active, not recruiting
Coon Rapids, Minnesota, United States, 55433
Suburban Imaging Active, not recruiting
Coon Rapids, Minnesota, United States, 55433
Mercy Hospital - Unity Campus AHL Active, not recruiting
Fridley, Minnesota, United States, 55432
Minnesota Oncology Hematology P.A. Active, not recruiting
Fridley, Minnesota, United States, 55432
Minnesota Oncology Hematology P.A. Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Laura Rockwell    612-863-8716    Laura.Rockwell@allina.com   
Abbot Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Laura Rockwell    612-863-8716    Laura.Rockwell@allina.com   
Virginia G. Piper Cancer Center at HonorHealth Active, not recruiting
Minneapolis, Minnesota, United States, 55407
Mayo Clinic - 200 First Street SW Active, not recruiting
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University School of Medicine in St. Louis Active, not recruiting
Creve Coeur, Missouri, United States, 63141
MidAmerica Division Inc. c/o Menorah Medical Center Active, not recruiting
Independence, Missouri, United States, 64057
Research Medical Center Active, not recruiting
Kansas City, Missouri, United States, 64132
Washington University School of Medicine in St. Louis Active, not recruiting
Saint Louis, Missouri, United States, 63110
Washington University School of Medicine in St. Louis Active, not recruiting
Saint Louis, Missouri, United States, 63129
Washington University School of Medicine in St. Louis Active, not recruiting
Saint Louis, Missouri, United States, 63136
United States, Nebraska
Nebraska Cancer Specialists - Midwest Cancer Center - Papillion Active, not recruiting
Omaha, Nebraska, United States, 68114
Nebraska Cancer Specialists - Midwest Cancer Center - Paillion Active, not recruiting
Omaha, Nebraska, United States, 68130
Nebraska Cancer Specialists- Midwest Cancer Center- Papillion Active, not recruiting
Papillion, Nebraska, United States, 68046-5706
United States, New Jersey
Rutgers Cancer Institute of New Jersey Active, not recruiting
New Brunswick, New Jersey, United States, 08903
United States, New York
New York Oncology Hematology, P.C. Active, not recruiting
Albany, New York, United States, 12206
New York Oncology Hematology, P.C. Active, not recruiting
Clifton Park, New York, United States, 12065
North Shore Hematology Oncology Associates., PC, 235 North Belle Mead Road Active, not recruiting
East Setauket, New York, United States, 11733
Columbia University Medical Center Active, not recruiting
New York, New York, United States, 10032
Memorial Sloan Kettering Cancer Center Active, not recruiting
New York, New York, United States, 10065
North Shore Hematology Oncology Associates., PC, 285 Sills Road Building 16 Active, not recruiting
Patchogue, New York, United States, 11772
United States, North Carolina
UNC Health Care System Active, not recruiting
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
The Ohio State University Wexner Medical Center, 460 W 10th Ave Recruiting
Columbus, Ohio, United States, 432100
Contact: Erika Prizzi    614-685-6046    cto.implementation@osumc.edu   
Principal Investigator: Sagar Sardesai, MD         
The Ohio State University Wexner Medical Center, 1145 Olentangy River Road Recruiting
Columbus, Ohio, United States, 43212
Contact: Erika Prizzi    614-685-6046    sagar.sardesai@osumc.edu   
Principal Investigator: Sagar Sardesai, MD         
United States, Oregon
Providence Medical Group Recruiting
Portland, Oregon, United States, 97213
Contact: Nikki Moxon    503-215-2619    nicole.moxon@providence.org   
United States, Pennsylvania
UPMC Hillman Cancer Center Mountainview Arnold Palmer Pavilion Recruiting
Greensburg, Pennsylvania, United States, 15601
Contact: Brenda Steele    412-641-2261    steebx@upmc.edu   
Principal Investigator: Adam Brufsky, MD         
UPMC Hillman Cancer Center UPMC East Recruiting
Monroeville, Pennsylvania, United States, 15146
Contact: Brenda Lee    412-641-2261    steebx@upmc.edu   
Principal Investigator: Adam Brufsky, MD         
UPMC Hillman Cancer Center Upper Saint Clair Recruiting
Pittsburgh, Pennsylvania, United States, 15102
Contact: Brenda Steele    412-641-2261    steebx@upmc.edu   
Principal Investigator: Adam Brufsky, MD         
Allegheny-Singer Research Institute, 320 East North Avenue Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15212
Magee-Womens Hospital of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Brenda Lee    412-641-2261    steebx@upmc.edu   
Principal Investigator: Adam Brufsky, MD         
UPMC Hillman Cancer Center UPMC Passavant Recruiting
Pittsburgh, Pennsylvania, United States, 15237
Contact: Brenda Lee    412-641-2261    steebx@upmc.edu   
Principal Investigator: Adam Brufsky, MD         
United States, Tennessee
Tennessee Oncology - Chattanooga Oncology & Hematology Associates Recruiting
Chattanooga, Tennessee, United States, 37404-1108
Contact: Bobby Stillman    423-702-7897    kenneth.stillman@sarahcannon.com   
Tennesee Oncology - PLLC Recruiting
Chattanooga, Tennessee, United States, 37404
Contact: Kimberly Tucker    423-698-1844    KimberlyTucker@sarahcannon.com   
Tenesse Oncology - PLLC Recruiting
Cleveland, Tennessee, United States, 37311
Contact: Kimberly Tucker    423-698-1844    Kimberly.Tucker@sarahcannon.com   
Tennessee Oncology, LLC Recruiting
Dickson, Tennessee, United States, 37055
Contact: Michelle Wittinghill    615-524-4239    laura.whittinghill@sarahcannon.com   
Tennessee Ocology, LLC Recruiting
Franklin, Tennessee, United States, 37067
Contact: Michelle Whittinghill    615-524-4239    laura.whittinghill@sarahcannon.com   
Tennessee Oncology, LLC Recruiting
Gallatin, Tennessee, United States, 37066
Contact: Michelle Whittinghill    615-524-4239    laura.whittinghill@sarahcannon.com   
West Cancer Center, 7945 Wolf River Blvd Active, not recruiting
Germantown, Tennessee, United States, 28138
Tennessee Oncology, LLC Recruiting
Hermitage, Tennessee, United States, 37076
Contact: Michelle Whittinghill    615-524-4239    laura.whittinghill@sarahcannon.com   
Tennessee Oncology, LLC Recruiting
Lebanon, Tennessee, United States, 37090
Contact: Michelle Whittinghill    615-524-4239    laura.whittinghill@sarahcannon.com   
Tennessee Oncology, LLC Recruiting
Murfreesboro, Tennessee, United States, 37129
Contact: Michelle Whittinghill    615-524-4239    laura.whittinghill@sarahcannon.com   
Sarah Cannon Cancer Institute/Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
Contact: Michelle Whittinghill    615-524-4239    laura.whittinghill@sarahcannon.com   
Tennessee Oncology, LLC Recruiting
Nashville, Tennessee, United States, 37203
Contact: Michelle Whittinghill    615-524-4239    laura.whittinghill@sarahcannon.com   
Vanderbilt Breast Cancer Center at One Hundred Oaks 719 Thompson Lane, Suite 25000 Active, not recruiting
Nashville, Tennessee, United States, 37204
Tennessee Ocology, LLC Recruiting
Nashville, Tennessee, United States, 37205
Contact: Michelle Whittinghill    615-524-4239    laura.whittinghill@sarahcannon.com   
Tennessee Oncology, LLC Recruiting
Nashville, Tennessee, United States, 37207
Contact: Michelle Whittinghill    615-524-4239    laura.whittinghill@sarahcannon.com   
Tenessee Oncology Recruiting
Nashville, Tennessee, United States, 37211
Contact: Michelle Whittinghill    615-329-7274    laura.whittinghill@sarahcannon.com   
Henry-Joyce Cancer Clinic 1301 Medical Center Drive 1903 The Vanderbilt Clinic Nashville, TN 37232 Active, not recruiting
Nashville, Tennessee, United States, 37232
Vanderbilt-Ingram Cancer Center Active, not recruiting
Nashville, Tennessee, United States, 37232
Tennessee Oncology, LLC Recruiting
Shelbyville, Tennessee, United States, 37160
Contact: Michelle Whittinghill    615-524-4239    laura.whittinghill@sarahcannon.com   
United States, Texas
Center for Cancer and Blood Disorders Active, not recruiting
Arlington, Texas, United States, 76014
Center for Cancer and Blood Disorders Active, not recruiting
Burleson, Texas, United States, 76028
Texas Oncology- Medical City Dallas Building D Active, not recruiting
Dallas, Texas, United States, 75230-6899
Texas Oncology - Baylor Charles A. Sammons Cancer Center Active, not recruiting
Dallas, Texas, United States, 75246-2006
Texas Oncology Active, not recruiting
Denton, Texas, United States, 76210
Center for Cancer and Blood Disorders Active, not recruiting
Fort Worth, Texas, United States, 76104-4611
Houston Methodist Hospital - 6565 Fannin St Recruiting
Houston, Texas, United States, 77030
Contact: Rhette Lambert    713-441-6662      
Contact       rlambert@houstonmethodist.org   
Texas Oncology-Longview Cancer Center Active, not recruiting
Longview, Texas, United States, 75601
Texas Oncology Active, not recruiting
Plano, Texas, United States, 75075-7753
US Oncology Active, not recruiting
Tyler, Texas, United States, 75702
Center for Cancer and Blood Disorders Active, not recruiting
Weatherford, Texas, United States, 76086
United States, Virginia
Virginia Cancer Specialists, PC Active, not recruiting
Alexandria, Virginia, United States, 22304
Virginia Cancer Specialists, PC Active, not recruiting
Arlington, Virginia, United States, 22205
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care Active, not recruiting
Blacksburg, Virginia, United States, 24060
Virginia Oncology Associates Active, not recruiting
Chesapeake, Virginia, United States, 23320
Virginia Cancer Specialists, PC Active, not recruiting
Fairfax, Virginia, United States, 22031-4629
Virginia Cancer Specialists, PC Active, not recruiting
Gainesville, Virginia, United States, 20155
Virginia Oncology Associates Active, not recruiting
Hampton, Virginia, United States, 23666
Virginia Cancer Specialists, PC Active, not recruiting
Leesburg, Virginia, United States, 20176
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care Active, not recruiting
Low Moor, Virginia, United States, 24457
Virginia Oncology Associates Active, not recruiting
Newport News, Virginia, United States, 23606
Virginia Oncology Associates, P.C. Active, not recruiting
Norfolk, Virginia, United States, 23502-0026
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care Active, not recruiting
Roanoke, Virginia, United States, 24014
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care Active, not recruiting
Salem, Virginia, United States, 24153
Virginia Oncology Associates Active, not recruiting
Virginia Beach, Virginia, United States, 23456
Virginia Cancer Specialists, PC Active, not recruiting
Woodbridge, Virginia, United States, 22191
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care Active, not recruiting
Wytheville, Virginia, United States, 24382
United States, Washington
Swedish Cancer Institute Active, not recruiting
Edmonds, Washington, United States, 98026
Swedish Cancer Institute Active, not recruiting
Issaquah, Washington, United States, 98029
Swedish Cancer Institute Active, not recruiting
Seattle, Washington, United States, 98104
Swedish Cancer Institute Active, not recruiting
Seattle, Washington, United States, 98122
Belgium
Universitair Zlekenhuis Brussel Active, not recruiting
Brussels, Belgium, 1090
Institut Jules Bordet Active, not recruiting
Bruxelles, Belgium, 1000
UZ Leuven Active, not recruiting
Leuven, Belgium, 3000
Clinique et Maternite Sainte-Elisabeth Active, not recruiting
Namur, Belgium, 5000
Canada, Alberta
Cross Cancer Institute, 11560 University Avenue Active, not recruiting
Edmonton, Alberta, Canada, TG6 1Z2
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre Active, not recruiting
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Sunnybrook Health Sciences Centre Active, not recruiting
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Jewish General Hospital, 3755 Côte-Sainte-Catherine Active, not recruiting
Montréal, Quebec, Canada, H3T 1E2
Jewish General Hospital, 3755 Côte-Sainte-Catherine Active, not recruiting
Québec, Quebec, Canada, H3T 1E2
France
Centre de Lutte Contre le Cancer - Institut de Cancerologie de l'Ouest - Paul Papin Active, not recruiting
Angers, France, 49005
CHU Besançon - Hôpital Jean Minjoz Active, not recruiting
Besançon, France, 25000
Institut Régional du Cancer de Montpellier Active, not recruiting
Montpellier, France
Institut Curie Active, not recruiting
Paris, France, 75248
Centre Eugène Marquis Active, not recruiting
Rennes Cedex, France, 35042
Florence Lerebours Active, not recruiting
Saint-Cloud, France, 92210
CHU de Nantes - Hôpital Nord Laennec Active, not recruiting
Saint-Herblain, France, 44805
Institut Claudius Regaud Active, not recruiting
Toulouse, France, 31059
Gustave Roussy Active, not recruiting
Villejuif, France, 94800
Germany
Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus Active, not recruiting
Frankfurt, Germany, 60389
Praxis für interdisziplinäre Onkologie & Hämatologie GbR Active, not recruiting
Freiburg im Breisgau, Germany, 79110
Facharztzentrum Eppendorf Active, not recruiting
Hamburg, Germany, 20249
Institut für Versorgungsforschung in der Onkologie Active, not recruiting
Koblenz, Germany, 56068
Praxis für Hämatologie und Internistische Onkologie Active, not recruiting
Velbert, Germany, 42551
Spain
Hospital Teresa Herrera, As Xubias, 84 Active, not recruiting
A Coruña, Spain, 15006
Hospital Quirón Barcelona, Plaza Alfonso Comín 5 Active, not recruiting
Barcelona, Spain, 08023
Hospital del Mar Active, not recruiting
Barcelona, Spain, 8003
Hospital Universitario Vall d'Hebron Active, not recruiting
Barcelona, Spain, 8035
Hospital de la Santa Creu i Sant Pau, Carrer del Mas Casanovas, 90 Active, not recruiting
Barcelona, Spain, 8041
Institut Catala d'Oncologia Hospitalet, Avenida Gran Via 199-203 Active, not recruiting
Hospitalet de Llobregat, Spain, 08908
Hospital Universitari Arnau de Vilanova de Lleida Active, not recruiting
Lleida, Spain, 25195
Hospital Universitario Ramon y Cajal Active, not recruiting
Madrid, Spain, 28034
Hospital Universitario 12 de Octubre Active, not recruiting
Madrid, Spain, 28041
Complexo Hospitalario Universitario de Santiago (CHUS) - Hospital Clinco Universaitario Active, not recruiting
Santiago De Compostela, Spain, 15706
Hospital Universitario Virgen del Rocío Active, not recruiting
Sevilla, Spain, 41013
United Kingdom
Colchester Hospital University NHS Foundation Trust - Colchester General Hospital, Turner Road Active, not recruiting
Colchester, ESS, United Kingdom, C04 5JL
The Arden Cancer Centre- University Hospital Coventry Active, not recruiting
Coventry, United Kingdom, CV2 2DX
County Durham and Darlington NHS Foundation Trust - University Hospital of North Durham Active, not recruiting
Durham, United Kingdom, DH1 5TW
The Royal Surrey County Hospital NHS Foundation Trust Active, not recruiting
Guildford, United Kingdom, GU2 7XX
The County Hospital, Wye Valley NHS Trust Active, not recruiting
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 Active, not recruiting
London, United Kingdom, NW3 2QG
The Christie NHS Foundation Trust Active, not recruiting
Manchester, United Kingdom, M20 4BX
Nottingham University Hospitals NHS Trust - City Hospital Active, not recruiting
Nottingham, United Kingdom, NG5 1PB
Plymouth Hospitals NHS Trust - Derriford Hospital Active, not recruiting
Plymouth, United Kingdom, PL6 8DH
Taunton and Somerset NHS Foundation Trust - Musgrove Park Hospital, Musgrove Park Hospital Active, not recruiting
Taunton, United Kingdom, TA1 5DA
The Mid Yorkshire Hospitals NHS Trust - Pinderfields Hospital Active, not recruiting
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: April 8, 2019
Last Verified: April 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
Camptothecin
Vinorelbine
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