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Testing Sacituzumab Govitecan Therapy in Patients With HER2-Negative Breast Cancer and Brain Metastases

Sponsor
Southwest Oncology Group (Other)
Overall Status
Recruiting
CT.gov ID
NCT04647916
Collaborator
National Cancer Institute (NCI) (NIH), Gilead Sciences (Industry)
44
Enrollment
296
Locations
1
Arm
49.6
Anticipated Duration (Months)
0.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This phase II trial studies the effect of sacituzumab govitecan in treating patients with HER2-negative breast cancer that has spread to the brain (brain metastases). Sacituzumab govitecan is a monoclonal antibody, called sacituzumab, linked to a chemotherapy drug, called govitecan. Sacituzumab is a form of targeted therapy because it attaches to specific molecules on the surface of cancer cells, known as Trop-2 receptors, and delivers govitecan to kill them. Giving sacituzumab govitecan may shrink the cancer in the brain and/or extend the time until the cancer gets worse.

Condition or Disease Intervention/Treatment Phase
  • Biological: Sacituzumab Govitecan
 Phase 2

Detailed Description

PRIMARY OBJECTIVE:
  1. To evaluate the intracranial objective response rate (ORR) (complete response [CR] or partial response [PR] by Response Assessment in Neuro-Oncology Brain Metastases [RANO-BM]) with sacituzumab govitecan (IMMU-132) in patients with HER2-negative metastatic breast cancer with brain involvement.
SECONDARY OBJECTIVES:

  1. To evaluate bi-compartmental progression-free survival in this population. II. To evaluate overall survival in this population. III. To assess safety and tolerability of sacituzumab govitecan (IMMU-132) treatment in this population.

  2. To evaluate ORR by hormone-receptor (HR) subgroup (HR+, HR-).

BANKING OBJECTIVE:
  1. To bank specimens for future correlative studies.
OUTLINE:

Patients receive sacituzumab govitecan intravenously (IV) over 1-3 hours on days 1 and 8. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

After completion of study registration, patients are followed up every 3 months for 1 year and then every 6 months for 1 year.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
44 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Trial of Sacituzumab Govitecan (IMMU-132) (NSC #820016) for Patients With HER2-Negative Breast Cancer and Brain Metastases
Actual Study Start Date :
Dec 15, 2020
Anticipated Primary Completion Date :
Dec 17, 2024
Anticipated Study Completion Date :
Feb 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment (sacituzumab govitecan)

Patients receive sacituzumab govitecan IV over 1-3 hours on days 1 and 8. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Biological: Sacituzumab Govitecan
Given IV
Other Names:
  • hRS7-SN38 Antibody Drug Conjugate
  • IMMU-132
  • RS7-SN38
  • Sacituzumab Govitecan-hziy
  • Trodelvy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Objective response rate (ORR) [Up to 2 years]

      ORR will be evaluated using use a Simon two-stage minimax design.

    Secondary Outcome Measures

    1. Overall survival [From date of registration to date of death due to any cause, assessed up to 2 years]

      Will use the Kaplan-Meier curves to estimate the respective survival curves.

    2. Progression-free survival [From date of registration to date of first documentation of progression or symptomatic deterioration or death due to any cause, assessed up to 2 years]

      Will use the Kaplan-Meier curves to estimate the respective survival curves.

    3. Incidence of adverse events [Up to 2 years]

      Adverse events will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The incidence of adverse events will be reported. Toxicity will be by grade and attribution to treatment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Participants must have histologically confirmed HER2-negative (per 2018 American Society of Clinical Oncology [ASCO]/College of American Pathologists [CAP] joint guideline) invasive breast cancer that has metastasized to the brain. NOTE: Pathology report must confirm HER2-negative invasive breast cancer. Brain metastases must be confirmed by radiology report

    • Participants must have an magnetic resonance imaging (MRI) of the brain within 28 days prior to registration and must have central nervous system metastases with at least one measurable brain metastasis >= 1.0 cm in size (per RANO-BM) that has not been irradiated, or has progressed despite prior radiation therapy (in the opinion of the treating physician). In the rare case that a previously irradiated brain metastasis is the sole target lesion and if there is concern about possible radiation necrosis, patient is eligible only if there is clear progression in the previously radiated lesion. Computed tomography (CT) of the head cannot substitute for brain MRI. All central nervous system (CNS) disease must be assessed and documented on the S2007 Brain Metastases Baseline Tumor Assessment Form

    • Participants may have measurable or non-measurable extracranial disease. All measurable disease must be assessed within 28 days prior to registration; all non-measurable disease must be assessed within 42 days prior to registration. Participants are NOT required to have extracranial disease, but must have scans done to document disease status at baseline. All extracranial disease must be assessed and documented on the Baseline Tumor Assessment Form (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1). NOTE: Brain lesions should not be included on the Baseline Tumor Assessment Form (RECIST 1.1) for this study

    • Participants must have had CNS progression after previous CNS-directed therapy (radiation therapy, surgery, or any combination of therapy)

    • Participants must have resolution of adverse event(s) of the most recent prior systemic anti-cancer therapy to < grade 2, with the exception of alopecia and =< grade 2 neuropathy, which are allowed

    • Participants with a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial

    • Participants must have Zubrod performance status 0 or 1

    • Participants must have history and physical exam obtained within 21 days prior to registration

    • Absolute neutrophil count (ANC) >= 1,500/mcL (obtained within 21 days prior to registration)

    • Platelet count >= 100,000/mcL (obtained within 21 days prior to registration)

    • Hemoglobin >= 9.0 g/dL (obtained within 21 days prior to registration)

    • Total bilirubin =< 1.5 times institutional upper limit of normal (ULN) (obtained within 21 days prior to registration)

    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x institutional ULN (obtained within 21 days prior to registration)

    • Participants must have a serum creatinine =< 1.5 times the institutional upper limit of normal (IULN) OR measured OR calculated creatinine clearance >= 30 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 21 days prior to registration

    • Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification, and must be class 2B or better

    • Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System

    • Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines

    Exclusion Criteria:

    • Participants must not have had more than 2 seizures within 28 days prior to registration

    • Participants must not have received systemic therapy (including small-molecule kinase inhibitors) or non-cytotoxic hormonal therapy (e.g., tamoxifen) within 7 days prior to registration

    • Participants must not have received anti-cancer biologic agents (antibodies, immune modulators, vaccines, cytokines) within 21 days prior to registration

    • Participants must not have received nitrosoureas or mitomycin C within 42 days, metronomic/protracted low-dose chemotherapy within 14 days, or other cytotoxic chemotherapy within 28 days prior to registration

    • Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral agents that are strong CYP3A4 inhibitors or inducers and who are unwilling or unable to change to antiretroviral therapies without such interactions are ineligible because of the potential for pharmacokinetic interactions with sacituzumab govitecan (IMMU-132)

    • Due to potential drug interactions of anti-retroviral drugs with sacituzumab govitecan (IMMU-132), participants must not have known active or chronic hepatitis B virus (HBV) infection, requiring suppressive therapy or known active hepatitis C virus (HCV) infection. Participants with a known history of HCV infection must have been treated and cured

    • Participants must not have received enzyme-inducing anti-epileptic agents (e.g., carbamazepine, phenytoin, phenobarbital, primidone) within 7 days prior to registration or within 14 days of planned start of cycle 1, day 1 treatment, and participants must not be planning to receive enzyme-inducing anti-epileptic agents (e.g., carbamazepine, phenytoin, phenobarbital, primidone) for the duration of protocol treatment

    • Participants must not be receiving warfarin (or other coumarin derivatives) at time of registration or be planning to receive warfarin (or other coumarin derivatives) for the duration of protocol treatment. Participants who are able to switch to low molecular weight heparin (LMWH) or direct oral anticoagulants (DOACs) prior to date of registration (and plan to remain off of warfarin or other coumarin derivatives) for the duration of protocol treatment) are eligible

    • Patients must not be receiving or be planning to receive concomitantly any other anti-cancer therapy, including endocrine therapy. Note: Concomitant hormone replacement therapy is allowed

    • Participants must not have a condition requiring ongoing systemic treatment with corticosteroids (> 4 mg daily dexamethasone [or bioequivalent]) or other immunosuppressive medications within 7 days prior to the baseline MRI. Corticosteroids administration must be stable and planned to remain =< 4 mg daily for the duration of protocol treatment. However, use of corticosteroids for clinical symptoms is allowed based upon treating physician discretion

    • Participants must not have uncontrolled diabetes in the opinion of the treating investigator 21 days prior to registration

    • Participants must not be pregnant or nursing. Women of reproductive potential must have a negative serum or urine pregnancy test within 7 days prior to registration. Women and men of reproductive potential must have agreed to use an effective contraceptive method for the duration of protocol treatment and for at least 6 months after the last dose of sacituzumab govitecan (IMMU-132). A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures outlined, he/she is responsible for beginning contraceptive measures

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anchorage Associates in Radiation Medicine Anchorage Alaska United States 98508
    2 Anchorage Radiation Therapy Center Anchorage Alaska United States 99504
    3 Alaska Breast Care and Surgery LLC Anchorage Alaska United States 99508
    4 Alaska Oncology and Hematology LLC Anchorage Alaska United States 99508
    5 Alaska Women's Cancer Care Anchorage Alaska United States 99508
    6 Anchorage Oncology Centre Anchorage Alaska United States 99508
    7 Katmai Oncology Group Anchorage Alaska United States 99508
    8 Providence Alaska Medical Center Anchorage Alaska United States 99508
    9 Fairbanks Memorial Hospital Fairbanks Alaska United States 99701
    10 Cancer Center at Saint Joseph's Phoenix Arizona United States 85004
    11 University of Arizona Cancer Center-Orange Grove Campus Tucson Arizona United States 85704
    12 Banner University Medical Center - Tucson Tucson Arizona United States 85719
    13 University of Arizona Cancer Center-North Campus Tucson Arizona United States 85719
    14 Mercy Hospital Fort Smith Fort Smith Arkansas United States 72903
    15 CHI Saint Vincent Cancer Center Hot Springs Hot Springs Arkansas United States 71913
    16 Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande California United States 93420
    17 Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California United States 91505
    18 UC Irvine Health Cancer Center-Newport Costa Mesa California United States 92627
    19 Epic Care-Dublin Dublin California United States 94568
    20 Bay Area Breast Surgeons Inc Emeryville California United States 94608
    21 Epic Care Partners in Cancer Care Emeryville California United States 94608
    22 Contra Costa Regional Medical Center Martinez California United States 94553-3156
    23 Alta Bates Summit Medical Center - Summit Campus Oakland California United States 94609
    24 Bay Area Tumor Institute Oakland California United States 94609
    25 UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California United States 92868
    26 Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo California United States 93401
    27 Mission Hope Medical Oncology - Santa Maria Santa Maria California United States 93444
    28 Saint John's Cancer Institute Santa Monica California United States 90404
    29 Epic Care Cyberknife Center Walnut Creek California United States 94597
    30 Rocky Mountain Cancer Centers-Aurora Aurora Colorado United States 80012
    31 The Medical Center of Aurora Aurora Colorado United States 80012
    32 Boulder Community Foothills Hospital Boulder Colorado United States 80303
    33 Rocky Mountain Cancer Centers-Boulder Boulder Colorado United States 80304
    34 Rocky Mountain Cancer Centers - Centennial Centennial Colorado United States 80112
    35 Penrose-Saint Francis Healthcare Colorado Springs Colorado United States 80907
    36 Rocky Mountain Cancer Centers-Penrose Colorado Springs Colorado United States 80907
    37 The Women's Imaging Center Denver Colorado United States 80209
    38 Porter Adventist Hospital Denver Colorado United States 80210
    39 Colorado Blood Cancer Institute Denver Colorado United States 80218
    40 Presbyterian - Saint Lukes Medical Center - Health One Denver Colorado United States 80218
    41 Rocky Mountain Cancer Centers-Midtown Denver Colorado United States 80218
    42 Rocky Mountain Cancer Centers-Rose Denver Colorado United States 80220
    43 Rose Medical Center Denver Colorado United States 80220
    44 Western Surgical Care Denver Colorado United States 80220
    45 Mercy Medical Center Durango Colorado United States 81301
    46 Southwest Oncology PC Durango Colorado United States 81301
    47 Mountain Blue Cancer Care Center - Swedish Englewood Colorado United States 80113
    48 Rocky Mountain Cancer Centers - Swedish Englewood Colorado United States 80113
    49 Swedish Medical Center Englewood Colorado United States 80113
    50 The Melanoma and Skin Cancer Institute Englewood Colorado United States 80113
    51 North Colorado Medical Center Greeley Colorado United States 80631
    52 Rocky Mountain Cancer Centers-Lakewood Lakewood Colorado United States 80228
    53 Saint Anthony Hospital Lakewood Colorado United States 80228
    54 Rocky Mountain Cancer Centers-Littleton Littleton Colorado United States 80120
    55 Littleton Adventist Hospital Littleton Colorado United States 80122
    56 Rocky Mountain Cancer Centers-Sky Ridge Lone Tree Colorado United States 80124
    57 Sky Ridge Medical Center Lone Tree Colorado United States 80124
    58 Longmont United Hospital Longmont Colorado United States 80501
    59 Rocky Mountain Cancer Centers-Longmont Longmont Colorado United States 80501
    60 McKee Medical Center Loveland Colorado United States 80539
    61 Parker Adventist Hospital Parker Colorado United States 80138
    62 Saint Mary Corwin Medical Center Pueblo Colorado United States 81004
    63 Rocky Mountain Cancer Centers-Thornton Thornton Colorado United States 80260
    64 Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia United States 31405
    65 Saint Alphonsus Cancer Care Center-Boise Boise Idaho United States 83706
    66 Saint Luke's Cancer Institute - Boise Boise Idaho United States 83712
    67 Saint Alphonsus Cancer Care Center-Caldwell Caldwell Idaho United States 83605
    68 Kootenai Health - Coeur d'Alene Coeur d'Alene Idaho United States 83814
    69 Walter Knox Memorial Hospital Emmett Idaho United States 83617
    70 Saint Luke's Cancer Institute - Fruitland Fruitland Idaho United States 83619
    71 Idaho Urologic Institute-Meridian Meridian Idaho United States 83642
    72 Saint Luke's Cancer Institute - Meridian Meridian Idaho United States 83642
    73 Saint Alphonsus Medical Center-Nampa Nampa Idaho United States 83686
    74 Saint Luke's Cancer Institute - Nampa Nampa Idaho United States 83686
    75 Kootenai Clinic Cancer Services - Post Falls Post Falls Idaho United States 83854
    76 Kootenai Cancer Clinic Sandpoint Idaho United States 83864
    77 Saint Luke's Cancer Institute - Twin Falls Twin Falls Idaho United States 83301
    78 Saint Anthony's Health Alton Illinois United States 62002
    79 Rush - Copley Medical Center Aurora Illinois United States 60504
    80 Illinois CancerCare-Bloomington Bloomington Illinois United States 61704
    81 Illinois CancerCare-Canton Canton Illinois United States 61520
    82 Memorial Hospital of Carbondale Carbondale Illinois United States 62902
    83 SIH Cancer Institute Carterville Illinois United States 62918
    84 Illinois CancerCare-Carthage Carthage Illinois United States 62321
    85 Centralia Oncology Clinic Centralia Illinois United States 62801
    86 Northwestern University Chicago Illinois United States 60611
    87 Carle on Vermilion Danville Illinois United States 61832
    88 Cancer Care Specialists of Illinois - Decatur Decatur Illinois United States 62526
    89 Decatur Memorial Hospital Decatur Illinois United States 62526
    90 Illinois CancerCare-Dixon Dixon Illinois United States 61021
    91 Carle Physician Group-Effingham Effingham Illinois United States 62401
    92 Crossroads Cancer Center Effingham Illinois United States 62401
    93 Illinois CancerCare-Eureka Eureka Illinois United States 61530
    94 Illinois CancerCare-Galesburg Galesburg Illinois United States 61401
    95 Western Illinois Cancer Treatment Center Galesburg Illinois United States 61401
    96 Illinois CancerCare-Kewanee Clinic Kewanee Illinois United States 61443
    97 Illinois CancerCare-Macomb Macomb Illinois United States 61455
    98 Carle Physician Group-Mattoon/Charleston Mattoon Illinois United States 61938
    99 Good Samaritan Regional Health Center Mount Vernon Illinois United States 62864
    100 Cancer Care Center of O'Fallon O'Fallon Illinois United States 62269
    101 Illinois CancerCare-Ottawa Clinic Ottawa Illinois United States 61350
    102 Illinois CancerCare-Pekin Pekin Illinois United States 61554
    103 Illinois CancerCare-Peoria Peoria Illinois United States 61615
    104 Methodist Medical Center of Illinois Peoria Illinois United States 61636
    105 Illinois CancerCare-Peru Peru Illinois United States 61354
    106 Valley Radiation Oncology Peru Illinois United States 61354
    107 Illinois CancerCare-Princeton Princeton Illinois United States 61356
    108 Southern Illinois University School of Medicine Springfield Illinois United States 62702
    109 Springfield Clinic Springfield Illinois United States 62702
    110 Memorial Medical Center Springfield Illinois United States 62781
    111 Carle Cancer Center Urbana Illinois United States 61801
    112 The Carle Foundation Hospital Urbana Illinois United States 61801
    113 Illinois CancerCare - Washington Washington Illinois United States 61571
    114 Rush-Copley Healthcare Center Yorkville Illinois United States 60560
    115 Reid Health Richmond Indiana United States 47374
    116 Mary Greeley Medical Center Ames Iowa United States 50010
    117 McFarland Clinic PC - Ames Ames Iowa United States 50010
    118 McFarland Clinic PC-Boone Boone Iowa United States 50036
    119 Saint Anthony Regional Hospital Carroll Iowa United States 51401
    120 Medical Oncology and Hematology Associates-West Des Moines Clive Iowa United States 50325
    121 Mercy Cancer Center-West Lakes Clive Iowa United States 50325
    122 Alegent Health Mercy Hospital Council Bluffs Iowa United States 51503
    123 Greater Regional Medical Center Creston Iowa United States 50801
    124 Iowa Methodist Medical Center Des Moines Iowa United States 50309
    125 Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa United States 50309
    126 Broadlawns Medical Center Des Moines Iowa United States 50314
    127 Medical Oncology and Hematology Associates-Laurel Des Moines Iowa United States 50314
    128 Mercy Medical Center - Des Moines Des Moines Iowa United States 50314
    129 Iowa Lutheran Hospital Des Moines Iowa United States 50316
    130 McFarland Clinic PC-Trinity Cancer Center Fort Dodge Iowa United States 50501
    131 Trinity Regional Medical Center Fort Dodge Iowa United States 50501
    132 McFarland Clinic PC-Jefferson Jefferson Iowa United States 50129
    133 McFarland Clinic PC-Marshalltown Marshalltown Iowa United States 50158
    134 Methodist West Hospital West Des Moines Iowa United States 50266-7700
    135 Mercy Medical Center-West Lakes West Des Moines Iowa United States 50266
    136 Central Care Cancer Center - Garden City Garden City Kansas United States 67846
    137 Central Care Cancer Center - Great Bend Great Bend Kansas United States 67530
    138 HaysMed University of Kansas Health System Hays Kansas United States 67601
    139 Lawrence Memorial Hospital Lawrence Kansas United States 66044
    140 Olathe Health Cancer Center Olathe Kansas United States 66061
    141 University of Kansas Cancer Center-Overland Park Overland Park Kansas United States 66210
    142 Ascension Via Christi - Pittsburg Pittsburg Kansas United States 66762
    143 Salina Regional Health Center Salina Kansas United States 67401
    144 University of Kansas Health System Saint Francis Campus Topeka Kansas United States 66606
    145 University of Kansas Hospital-Westwood Cancer Center Westwood Kansas United States 66205
    146 Flaget Memorial Hospital Bardstown Kentucky United States 40004
    147 Commonwealth Cancer Center-Corbin Corbin Kentucky United States 40701
    148 Saint Joseph Radiation Oncology Resource Center Lexington Kentucky United States 40504
    149 Saint Joseph Hospital East Lexington Kentucky United States 40509
    150 Saint Joseph London London Kentucky United States 40741
    151 Jewish Hospital Louisville Kentucky United States 40202
    152 Saints Mary and Elizabeth Hospital Louisville Kentucky United States 40215
    153 UofL Health Medical Center Northeast Louisville Kentucky United States 40245
    154 Jewish Hospital Medical Center South Shepherdsville Kentucky United States 40165
    155 Walter Reed National Military Medical Center Bethesda Maryland United States 20889-5600
    156 Dana-Farber Cancer Institute Boston Massachusetts United States 02215
    157 Hickman Cancer Center Adrian Michigan United States 49221
    158 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109
    159 Toledo Clinic Cancer Centers-Monroe Monroe Michigan United States 48162
    160 Ascension Providence Hospitals - Novi Novi Michigan United States 48374
    161 Ascension Providence Hospitals - Southfield Southfield Michigan United States 48075
    162 Mayo Clinic in Rochester Rochester Minnesota United States 55905
    163 Baptist Memorial Hospital and Cancer Center-Golden Triangle Columbus Mississippi United States 39705
    164 Baptist Cancer Center-Grenada Grenada Mississippi United States 38901
    165 Baptist Memorial Hospital and Cancer Center-Oxford Oxford Mississippi United States 38655
    166 Baptist Memorial Hospital and Cancer Center-Desoto Southhaven Mississippi United States 38671
    167 Saint Louis Cancer and Breast Institute-Ballwin Ballwin Missouri United States 63011
    168 Central Care Cancer Center - Bolivar Bolivar Missouri United States 65613
    169 Saint Francis Medical Center Cape Girardeau Missouri United States 63703
    170 Southeast Cancer Center Cape Girardeau Missouri United States 63703
    171 Parkland Health Center - Farmington Farmington Missouri United States 63640
    172 Capital Region Southwest Campus Jefferson City Missouri United States 65109
    173 Freeman Health System Joplin Missouri United States 64804
    174 Mercy Hospital Joplin Joplin Missouri United States 64804
    175 Truman Medical Centers Kansas City Missouri United States 64108
    176 University of Kansas Cancer Center - North Kansas City Missouri United States 64154
    177 University of Kansas Cancer Center - Lee's Summit Lee's Summit Missouri United States 64064
    178 University of Kansas Cancer Center at North Kansas City Hospital North Kansas City Missouri United States 64116
    179 Delbert Day Cancer Institute at PCRMC Rolla Missouri United States 65401
    180 Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri United States 65401
    181 Heartland Regional Medical Center Saint Joseph Missouri United States 64506
    182 Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri United States 63109
    183 Mercy Hospital South Saint Louis Missouri United States 63128
    184 Missouri Baptist Medical Center Saint Louis Missouri United States 63131
    185 Mercy Hospital Saint Louis Saint Louis Missouri United States 63141
    186 Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri United States 63670
    187 Mercy Hospital Springfield Springfield Missouri United States 65804
    188 CoxHealth South Hospital Springfield Missouri United States 65807
    189 Missouri Baptist Sullivan Hospital Sullivan Missouri United States 63080
    190 Missouri Baptist Outpatient Center-Sunset Hills Sunset Hills Missouri United States 63127
    191 Mercy Hospital Washington Washington Missouri United States 63090
    192 Community Hospital of Anaconda Anaconda Montana United States 59711
    193 Billings Clinic Cancer Center Billings Montana United States 59101
    194 Bozeman Deaconess Hospital Bozeman Montana United States 59715
    195 Benefis Healthcare- Sletten Cancer Institute Great Falls Montana United States 59405
    196 Great Falls Clinic Great Falls Montana United States 59405
    197 Kalispell Regional Medical Center Kalispell Montana United States 59901
    198 Saint Patrick Hospital - Community Hospital Missoula Montana United States 59802
    199 Community Medical Hospital Missoula Montana United States 59804
    200 CHI Health Saint Francis Grand Island Nebraska United States 68803
    201 CHI Health Good Samaritan Kearney Nebraska United States 68847
    202 Saint Elizabeth Regional Medical Center Lincoln Nebraska United States 68510
    203 Alegent Health Immanuel Medical Center Omaha Nebraska United States 68122
    204 Alegent Health Bergan Mercy Medical Center Omaha Nebraska United States 68124
    205 Alegent Health Lakeside Hospital Omaha Nebraska United States 68130
    206 Creighton University Medical Center Omaha Nebraska United States 68131
    207 Midlands Community Hospital Papillion Nebraska United States 68046
    208 Solinsky Center for Cancer Care Manchester New Hampshire United States 03103
    209 University of New Mexico Cancer Center Albuquerque New Mexico United States 87102
    210 Northwell Health/Center for Advanced Medicine Lake Success New York United States 11042
    211 Good Samaritan Hospital Medical Center West Islip New York United States 11795
    212 Southeastern Medical Oncology Center-Clinton Clinton North Carolina United States 28328
    213 Southeastern Medical Oncology Center-Goldsboro Goldsboro North Carolina United States 27534
    214 Southeastern Medical Oncology Center-Jacksonville Jacksonville North Carolina United States 28546
    215 Dayton Physicians LLC-Miami Valley South Centerville Ohio United States 45459
    216 Miami Valley Hospital South Centerville Ohio United States 45459
    217 Good Samaritan Hospital - Cincinnati Cincinnati Ohio United States 45220
    218 Bethesda North Hospital Cincinnati Ohio United States 45242
    219 TriHealth Cancer Institute-Westside Cincinnati Ohio United States 45247
    220 TriHealth Cancer Institute-Anderson Cincinnati Ohio United States 45255
    221 Cleveland Clinic Cancer Center/Fairview Hospital Cleveland Ohio United States 44111
    222 Cleveland Clinic Foundation Cleveland Ohio United States 44195
    223 Miami Valley Hospital Dayton Ohio United States 45409
    224 Dayton Physician LLC-Miami Valley Hospital North Dayton Ohio United States 45415
    225 Miami Valley Hospital North Dayton Ohio United States 45415
    226 Armes Family Cancer Center Findlay Ohio United States 45840
    227 Dayton Physicians LLC-Atrium Franklin Ohio United States 45005
    228 Greater Dayton Cancer Center Kettering Ohio United States 45409
    229 Kettering Medical Center Kettering Ohio United States 45429
    230 Cleveland Clinic Cancer Center Mansfield Mansfield Ohio United States 44906
    231 Hillcrest Hospital Cancer Center Mayfield Heights Ohio United States 44124
    232 North Coast Cancer Care Sandusky Ohio United States 44870
    233 Springfield Regional Cancer Center Springfield Ohio United States 45504
    234 Mercy Health - Saint Anne Hospital Toledo Ohio United States 43623
    235 Toledo Clinic Cancer Centers-Toledo Toledo Ohio United States 43623
    236 South Pointe Hospital Warrensville Heights Ohio United States 44122
    237 Mercy Hospital Oklahoma City Oklahoma City Oklahoma United States 73120
    238 Saint Alphonsus Medical Center-Baker City Baker City Oregon United States 97814
    239 Saint Charles Health System Bend Oregon United States 97701
    240 Clackamas Radiation Oncology Center Clackamas Oregon United States 97015
    241 Providence Cancer Institute Clackamas Clinic Clackamas Oregon United States 97015
    242 Bay Area Hospital Coos Bay Oregon United States 97420
    243 Providence Newberg Medical Center Newberg Oregon United States 97132
    244 Saint Alphonsus Medical Center-Ontario Ontario Oregon United States 97914
    245 Providence Portland Medical Center Portland Oregon United States 97213
    246 Providence Saint Vincent Medical Center Portland Oregon United States 97225
    247 Saint Charles Health System-Redmond Redmond Oregon United States 97756
    248 UPMC Camp Hill Camp Hill Pennsylvania United States 17011
    249 UPMC Pinnacle Cancer Center/Community Osteopathic Campus Harrisburg Pennsylvania United States 17109
    250 UPMC-Mercy Hospital Pittsburgh Pennsylvania United States 15219
    251 University of Pittsburgh Cancer Institute (UPCI) Pittsburgh Pennsylvania United States 15232
    252 UPMC Susquehanna Williamsport Pennsylvania United States 17701
    253 UPMC Memorial York Pennsylvania United States 17408
    254 Gibbs Cancer Center-Gaffney Gaffney South Carolina United States 29341
    255 Gibbs Cancer Center-Pelham Greer South Carolina United States 29651
    256 Spartanburg Medical Center Spartanburg South Carolina United States 29303
    257 MGC Hematology Oncology-Union Union South Carolina United States 29379
    258 Baptist Memorial Hospital and Cancer Center-Collierville Collierville Tennessee United States 38017
    259 Vanderbilt-Ingram Cancer Center Cool Springs Franklin Tennessee United States 37067
    260 Baptist Memorial Hospital and Cancer Center-Memphis Memphis Tennessee United States 38120
    261 Vanderbilt Breast Center at One Hundred Oaks Nashville Tennessee United States 37204
    262 Vanderbilt University/Ingram Cancer Center Nashville Tennessee United States 37232
    263 Saint Joseph Regional Cancer Center Bryan Texas United States 77802
    264 M D Anderson Cancer Center Houston Texas United States 77030
    265 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78229
    266 Providence Regional Cancer System-Aberdeen Aberdeen Washington United States 98520
    267 PeaceHealth Saint Joseph Medical Center Bellingham Washington United States 98225
    268 Harrison HealthPartners Hematology and Oncology-Bremerton Bremerton Washington United States 98310
    269 Harrison Medical Center Bremerton Washington United States 98310
    270 Highline Medical Center-Main Campus Burien Washington United States 98166
    271 Providence Regional Cancer System-Centralia Centralia Washington United States 98531
    272 Swedish Cancer Institute-Edmonds Edmonds Washington United States 98026
    273 Saint Elizabeth Hospital Enumclaw Washington United States 98022
    274 Providence Regional Cancer Partnership Everett Washington United States 98201
    275 Saint Francis Hospital Federal Way Washington United States 98003
    276 Swedish Cancer Institute-Issaquah Issaquah Washington United States 98029
    277 Kadlec Clinic Hematology and Oncology Kennewick Washington United States 99336
    278 Providence Regional Cancer System-Lacey Lacey Washington United States 98503
    279 Saint Clare Hospital Lakewood Washington United States 98499
    280 PeaceHealth Saint John Medical Center Longview Washington United States 98632
    281 Jefferson Healthcare Port Townsend Washington United States 98368
    282 Harrison HealthPartners Hematology and Oncology-Poulsbo Poulsbo Washington United States 98370
    283 Pacific Gynecology Specialists Seattle Washington United States 98104
    284 Swedish Medical Center-Ballard Campus Seattle Washington United States 98107
    285 Swedish Medical Center-First Hill Seattle Washington United States 98122-4307
    286 Swedish Medical Center-Cherry Hill Seattle Washington United States 98122-5711
    287 PeaceHealth United General Medical Center Sedro-Woolley Washington United States 98284
    288 Providence Regional Cancer System-Shelton Shelton Washington United States 98584
    289 Franciscan Research Center-Northwest Medical Plaza Tacoma Washington United States 98405
    290 Northwest Medical Specialties PLLC Tacoma Washington United States 98405
    291 PeaceHealth Southwest Medical Center Vancouver Washington United States 98664
    292 Providence Saint Mary Regional Cancer Center Walla Walla Washington United States 99362
    293 Providence Regional Cancer System-Yelm Yelm Washington United States 98597
    294 Cheyenne Regional Medical Center-West Cheyenne Wyoming United States 82001
    295 Billings Clinic-Cody Cody Wyoming United States 82414
    296 Welch Cancer Center Sheridan Wyoming United States 82801

    Sponsors and Collaborators

    • Southwest Oncology Group
    • National Cancer Institute (NCI)
    • Gilead Sciences

    Investigators

    • Principal Investigator: Andrew J Brenner, Southwest Oncology Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Southwest Oncology Group
    ClinicalTrials.gov Identifier:
    NCT04647916
    Other Study ID Numbers:
    • S2007
    • NCI-2020-07706
    • S2007
    • S2007
    • U10CA180888
    First Posted:
    Dec 1, 2020
    Last Update Posted:
    Jul 22, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Breast Neoplasms
    Brain Neoplasms
    Neoplasms
    Camptothecin
    Irinotecan
    Immunoconjugates

    Study Results

    No Results Posted as of Jul 22, 2022