AzTrials
AzTrials

Anatomic Stage IV Breast Cancer AJCC v8Phase 2NCT04647916

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

A Phase 2 study testing Sacituzumab Govitecan in people with Anatomic Stage IV Breast Cancer AJCC v8 and Invasive Breast Carcinoma, run by SWOG Cancer Research Network at 296 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sacituzumab Govitecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
296 sitesUnited States
Study dates
8 Jun 2021to Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

296 sites in 1 country.

296 sites in 1 country

United States296 sites

  • Providence Regional Cancer System-Aberdeen

    Aberdeen, Washington, 98520

  • Hickman Cancer Center

    Adrian, Michigan, 49221

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87102

  • Saint Anthony's Health

    Alton, Illinois, 62002

  • Mary Greeley Medical Center

    Ames, Iowa, 50010

  • McFarland Clinic PC - Ames

    Ames, Iowa, 50010

  • Community Hospital of Anaconda

    Anaconda, Montana, 59711

  • Anchorage Associates in Radiation Medicine

    Anchorage, Alaska, 98508

  • Anchorage Radiation Therapy Center

    Anchorage, Alaska, 99504

  • Alaska Breast Care and Surgery LLC

    Anchorage, Alaska, 99508

  • Alaska Oncology and Hematology LLC

    Anchorage, Alaska, 99508

  • Alaska Women's Cancer Care

    Anchorage, Alaska, 99508

  • Anchorage Oncology Centre

    Anchorage, Alaska, 99508

  • Katmai Oncology Group

    Anchorage, Alaska, 99508

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Mission Hope Medical Oncology - Arroyo Grande

    Arroyo Grande, California, 93420

  • Rocky Mountain Cancer Centers-Aurora

    Aurora, Colorado, 80012

  • The Medical Center of Aurora

    Aurora, Colorado, 80012

  • Rush - Copley Medical Center

    Aurora, Illinois, 60504

  • Saint Alphonsus Medical Center-Baker City

    Baker City, Oregon, 97814

  • Saint Louis Cancer and Breast Institute-Ballwin

    Ballwin, Missouri, 63011

  • Flaget Memorial Hospital

    Bardstown, Kentucky, 40004

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

  • Saint Charles Health System

    Bend, Oregon, 97701

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889-5600

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712

  • Central Care Cancer Center - Bolivar

    Bolivar, Missouri, 65613

  • McFarland Clinic PC-Boone

    Boone, Iowa, 50036

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Boulder Community Foothills Hospital

    Boulder, Colorado, 80303

  • Rocky Mountain Cancer Centers-Boulder

    Boulder, Colorado, 80304

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Harrison HealthPartners Hematology and Oncology-Bremerton

    Bremerton, Washington, 98310

  • Harrison Medical Center

    Bremerton, Washington, 98310

  • Saint Joseph Regional Cancer Center

    Bryan, Texas, 77802

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

  • Highline Medical Center-Main Campus

    Burien, Washington, 98166

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605

  • UPMC Camp Hill

    Camp Hill, Pennsylvania, 17011

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Southeast Cancer Center

    Cape Girardeau, Missouri, 63703

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62902

  • Saint Anthony Regional Hospital

    Carroll, Iowa, 51401

  • SIH Cancer Institute

    Carterville, Illinois, 62918

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Rocky Mountain Cancer Centers - Centennial

    Centennial, Colorado, 80112

  • Dayton Physicians LLC-Miami Valley South

    Centerville, Ohio, 45459

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

  • Providence Regional Cancer System-Centralia

    Centralia, Washington, 98531

  • Cheyenne Regional Medical Center-West

    Cheyenne, Wyoming, 82001

  • Northwestern University

    Chicago, Illinois, 60611

  • Good Samaritan Hospital - Cincinnati

    Cincinnati, Ohio, 45220

  • Bethesda North Hospital

    Cincinnati, Ohio, 45242

  • TriHealth Cancer Institute-Westside

    Cincinnati, Ohio, 45247

  • TriHealth Cancer Institute-Anderson

    Cincinnati, Ohio, 45255

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

  • Providence Cancer Institute Clackamas Clinic

    Clackamas, Oregon, 97015

  • Cleveland Clinic Cancer Center/Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Southeastern Medical Oncology Center-Clinton

    Clinton, North Carolina, 28328

  • Medical Oncology and Hematology Associates-West Des Moines

    Clive, Iowa, 50325

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

  • Billings Clinic-Cody

    Cody, Wyoming, 82414

  • Kootenai Health - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814

  • Baptist Memorial Hospital and Cancer Center-Collierville

    Collierville, Tennessee, 38017

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • Rocky Mountain Cancer Centers-Penrose

    Colorado Springs, Colorado, 80907

  • Baptist Memorial Hospital and Cancer Center-Golden Triangle

    Columbus, Mississippi, 39705

  • Bay Area Hospital

    Coos Bay, Oregon, 97420

  • Commonwealth Cancer Center-Corbin

    Corbin, Kentucky, 40701

  • UC Irvine Health Cancer Center-Newport

    Costa Mesa, California, 92627

  • Alegent Health Mercy Hospital

    Council Bluffs, Iowa, 51503

  • Greater Regional Medical Center

    Creston, Iowa, 50801

  • Carle on Vermilion

    Danville, Illinois, 61832

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Dayton Physician LLC-Miami Valley Hospital North

    Dayton, Ohio, 45415

  • Miami Valley Hospital North

    Dayton, Ohio, 45415

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • The Women's Imaging Center

    Denver, Colorado, 80209

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • Presbyterian - Saint Lukes Medical Center - Health One

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers-Midtown

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers-Rose

    Denver, Colorado, 80220

  • Rose Medical Center

    Denver, Colorado, 80220

  • Western Surgical Care

    Denver, Colorado, 80220

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Des Moines

    Des Moines, Iowa, 50309

  • Broadlawns Medical Center

    Des Moines, Iowa, 50314

  • Medical Oncology and Hematology Associates-Laurel

    Des Moines, Iowa, 50314

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Illinois CancerCare-Dixon

    Dixon, Illinois, 61021

  • Epic Care-Dublin

    Dublin, California, 94568

  • Mercy Medical Center

    Durango, Colorado, 81301

  • Southwest Oncology PC

    Durango, Colorado, 81301

  • Swedish Cancer Institute-Edmonds

    Edmonds, Washington, 98026

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Bay Area Breast Surgeons Inc

    Emeryville, California, 94608

  • Epic Care Partners in Cancer Care

    Emeryville, California, 94608

  • Walter Knox Memorial Hospital

    Emmett, Idaho, 83617

  • Mountain Blue Cancer Care Center - Swedish

    Englewood, Colorado, 80113

  • Rocky Mountain Cancer Centers - Swedish

    Englewood, Colorado, 80113

  • Swedish Medical Center

    Englewood, Colorado, 80113

  • The Melanoma and Skin Cancer Institute

    Englewood, Colorado, 80113

  • Saint Elizabeth Hospital

    Enumclaw, Washington, 98022

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

  • Fairbanks Memorial Hospital

    Fairbanks, Alaska, 99701

  • Parkland Health Center - Farmington

    Farmington, Missouri, 63640

  • Saint Francis Hospital

    Federal Way, Washington, 98003

  • Armes Family Cancer Center

    Findlay, Ohio, 45840

  • McFarland Clinic PC-Trinity Cancer Center

    Fort Dodge, Iowa, 50501

  • Trinity Regional Medical Center

    Fort Dodge, Iowa, 50501

  • Mercy Hospital Fort Smith

    Fort Smith, Arkansas, 72903

  • Dayton Physicians LLC-Atrium

    Franklin, Ohio, 45005

  • Vanderbilt-Ingram Cancer Center Cool Springs

    Franklin, Tennessee, 37067

  • Saint Luke's Cancer Institute - Fruitland

    Fruitland, Idaho, 83619

  • Gibbs Cancer Center-Gaffney

    Gaffney, South Carolina, 29341

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401

  • Central Care Cancer Center - Garden City

    Garden City, Kansas, 67846

  • Southeastern Medical Oncology Center-Goldsboro

    Goldsboro, North Carolina, 27534

  • CHI Health Saint Francis

    Grand Island, Nebraska, 68803

  • Central Care Cancer Center - Great Bend

    Great Bend, Kansas, 67530

  • Benefis Healthcare- Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • Gibbs Cancer Center-Pelham

    Greer, South Carolina, 29651

  • Baptist Cancer Center-Grenada

    Grenada, Mississippi, 38901

  • UPMC Pinnacle Cancer Center/Community Osteopathic Campus

    Harrisburg, Pennsylvania, 17109

  • HaysMed University of Kansas Health System

    Hays, Kansas, 67601

  • CHI Saint Vincent Cancer Center Hot Springs

    Hot Springs, Arkansas, 71913

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • Swedish Cancer Institute-Issaquah

    Issaquah, Washington, 98029

  • Southeastern Medical Oncology Center-Jacksonville

    Jacksonville, North Carolina, 28546

  • McFarland Clinic PC-Jefferson

    Jefferson, Iowa, 50129

  • Capital Region Southwest Campus

    Jefferson City, Missouri, 65109

  • Freeman Health System

    Joplin, Missouri, 64804

  • Mercy Hospital Joplin

    Joplin, Missouri, 64804

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Truman Medical Centers

    Kansas City, Missouri, 64108

  • University of Kansas Cancer Center - North

    Kansas City, Missouri, 64154

  • CHI Health Good Samaritan

    Kearney, Nebraska, 68847

  • Kadlec Clinic Hematology and Oncology

    Kennewick, Washington, 99336

  • Greater Dayton Cancer Center

    Kettering, Ohio, 45409

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

  • Providence Regional Cancer System-Lacey

    Lacey, Washington, 98503

  • Northwell Health/Center for Advanced Medicine

    Lake Success, New York, 11042

  • Rocky Mountain Cancer Centers-Lakewood

    Lakewood, Colorado, 80228

  • Saint Anthony Hospital

    Lakewood, Colorado, 80228

  • Saint Clare Hospital

    Lakewood, Washington, 98499

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • University of Kansas Cancer Center - Lee's Summit

    Lee's Summit, Missouri, 64064

  • Saint Joseph Radiation Oncology Resource Center

    Lexington, Kentucky, 40504

  • Saint Joseph Hospital East

    Lexington, Kentucky, 40509

  • Saint Elizabeth Regional Medical Center

    Lincoln, Nebraska, 68510

  • Rocky Mountain Cancer Centers-Littleton

    Littleton, Colorado, 80120

  • Littleton Adventist Hospital

    Littleton, Colorado, 80122

  • Saint Joseph London

    London, Kentucky, 40741

  • Rocky Mountain Cancer Centers-Sky Ridge

    Lone Tree, Colorado, 80124

  • Sky Ridge Medical Center

    Lone Tree, Colorado, 80124

  • Longmont United Hospital

    Longmont, Colorado, 80501

  • Rocky Mountain Cancer Centers-Longmont

    Longmont, Colorado, 80501

  • PeaceHealth Saint John Medical Center

    Longview, Washington, 98632

  • Jewish Hospital

    Louisville, Kentucky, 40202

  • Saints Mary and Elizabeth Hospital

    Louisville, Kentucky, 40215

  • UofL Health Medical Center Northeast

    Louisville, Kentucky, 40245

  • McKee Medical Center

    Loveland, Colorado, 80539

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

  • Solinsky Center for Cancer Care

    Manchester, New Hampshire, 03103

  • Cleveland Clinic Cancer Center Mansfield

    Mansfield, Ohio, 44906

  • McFarland Clinic PC-Marshalltown

    Marshalltown, Iowa, 50158

  • Contra Costa Regional Medical Center

    Martinez, California, 94553-3156

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

  • Hillcrest Hospital Cancer Center

    Mayfield Heights, Ohio, 44124

  • Baptist Memorial Hospital and Cancer Center-Memphis

    Memphis, Tennessee, 38120

  • Idaho Urologic Institute-Meridian

    Meridian, Idaho, 83642

  • Saint Luke's Cancer Institute - Meridian

    Meridian, Idaho, 83642

  • Saint Patrick Hospital - Community Hospital

    Missoula, Montana, 59802

  • Community Medical Hospital

    Missoula, Montana, 59804

  • Toledo Clinic Cancer Centers-Monroe

    Monroe, Michigan, 48162

  • Good Samaritan Regional Health Center

    Mount Vernon, Illinois, 62864

  • Saint Alphonsus Medical Center-Nampa

    Nampa, Idaho, 83686

  • Saint Luke's Cancer Institute - Nampa

    Nampa, Idaho, 83686

  • Vanderbilt Breast Center at One Hundred Oaks

    Nashville, Tennessee, 37204

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Providence Newberg Medical Center

    Newberg, Oregon, 97132

  • University of Kansas Cancer Center at North Kansas City Hospital

    North Kansas City, Missouri, 64116

  • Ascension Providence Hospitals - Novi

    Novi, Michigan, 48374

  • Cancer Care Center of O'Fallon

    O'Fallon, Illinois, 62269

  • Alta Bates Summit Medical Center - Summit Campus

    Oakland, California, 94609

  • Bay Area Tumor Institute

    Oakland, California, 94609

  • Mercy Hospital Oklahoma City

    Oklahoma City, Oklahoma, 73120

  • Olathe Health Cancer Center

    Olathe, Kansas, 66061

  • Alegent Health Immanuel Medical Center

    Omaha, Nebraska, 68122

  • Alegent Health Bergan Mercy Medical Center

    Omaha, Nebraska, 68124

  • Alegent Health Lakeside Hospital

    Omaha, Nebraska, 68130

  • Creighton University Medical Center

    Omaha, Nebraska, 68131

  • Saint Alphonsus Medical Center-Ontario

    Ontario, Oregon, 97914

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

  • University of Kansas Cancer Center-Overland Park

    Overland Park, Kansas, 66210

  • Baptist Memorial Hospital and Cancer Center-Oxford

    Oxford, Mississippi, 38655

  • Midlands Community Hospital

    Papillion, Nebraska, 68046

  • Parker Adventist Hospital

    Parker, Colorado, 80138

  • Illinois CancerCare-Pekin

    Pekin, Illinois, 61554

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • Illinois CancerCare-Peru

    Peru, Illinois, 61354

  • Valley Radiation Oncology

    Peru, Illinois, 61354

  • Cancer Center at Saint Joseph's

    Phoenix, Arizona, 85004

  • Ascension Via Christi - Pittsburg

    Pittsburg, Kansas, 66762

  • UPMC-Mercy Hospital

    Pittsburgh, Pennsylvania, 15219

  • University of Pittsburgh Cancer Institute (UPCI)

    Pittsburgh, Pennsylvania, 15232

  • Jefferson Healthcare

    Port Townsend, Washington, 98368

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225

  • Kootenai Clinic Cancer Services - Post Falls

    Post Falls, Idaho, 83854

  • Harrison HealthPartners Hematology and Oncology-Poulsbo

    Poulsbo, Washington, 98370

  • Illinois CancerCare-Princeton

    Princeton, Illinois, 61356

  • Saint Mary Corwin Medical Center

    Pueblo, Colorado, 81004

  • Saint Charles Health System-Redmond

    Redmond, Oregon, 97756

  • Reid Health

    Richmond, Indiana, 47374

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

  • Delbert Day Cancer Institute at PCRMC

    Rolla, Missouri, 65401

  • Mercy Clinic-Rolla-Cancer and Hematology

    Rolla, Missouri, 65401

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64506

  • Sainte Genevieve County Memorial Hospital

    Sainte Genevieve, Missouri, 63670

  • Salina Regional Health Center

    Salina, Kansas, 67401

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • Pacific Central Coast Health Center-San Luis Obispo

    San Luis Obispo, California, 93401

  • Kootenai Cancer Clinic

    Sandpoint, Idaho, 83864

  • North Coast Cancer Care

    Sandusky, Ohio, 44870

  • Mission Hope Medical Oncology - Santa Maria

    Santa Maria, California, 93444

  • Saint John's Cancer Institute

    Santa Monica, California, 90404

  • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

    Savannah, Georgia, 31405

  • Pacific Gynecology Specialists

    Seattle, Washington, 98104

  • Swedish Medical Center-Ballard Campus

    Seattle, Washington, 98107

  • Swedish Medical Center-First Hill

    Seattle, Washington, 98122-4307

  • Swedish Medical Center-Cherry Hill

    Seattle, Washington, 98122-5711

  • PeaceHealth United General Medical Center

    Sedro-Woolley, Washington, 98284

  • Providence Regional Cancer System-Shelton

    Shelton, Washington, 98584

  • Jewish Hospital Medical Center South

    Shepherdsville, Kentucky, 40165

  • Welch Cancer Center

    Sheridan, Wyoming, 82801

  • Ascension Providence Hospitals - Southfield

    Southfield, Michigan, 48075

  • Baptist Memorial Hospital and Cancer Center-Desoto

    Southhaven, Mississippi, 38671

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

  • Springfield Clinic

    Springfield, Illinois, 62702

  • Memorial Medical Center

    Springfield, Illinois, 62781

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • CoxHealth South Hospital

    Springfield, Missouri, 65807

  • Springfield Regional Cancer Center

    Springfield, Ohio, 45504

  • Saint Louis Cancer and Breast Institute-South City

    St Louis, Missouri, 63109

  • Mercy Hospital South

    St Louis, Missouri, 63128

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

  • Missouri Baptist Sullivan Hospital

    Sullivan, Missouri, 63080

  • Missouri Baptist Outpatient Center-Sunset Hills

    Sunset Hills, Missouri, 63127

  • Franciscan Research Center-Northwest Medical Plaza

    Tacoma, Washington, 98405

  • Northwest Medical Specialties PLLC

    Tacoma, Washington, 98405

  • Rocky Mountain Cancer Centers-Thornton

    Thornton, Colorado, 80260

  • Mercy Health - Saint Anne Hospital

    Toledo, Ohio, 43623

  • Toledo Clinic Cancer Centers-Toledo

    Toledo, Ohio, 43623

  • University of Kansas Health System Saint Francis Campus

    Topeka, Kansas, 66606

  • University of Arizona Cancer Center-Orange Grove Campus

    Tucson, Arizona, 85704

  • Banner University Medical Center - Tucson

    Tucson, Arizona, 85719

  • University of Arizona Cancer Center-North Campus

    Tucson, Arizona, 85719

  • Saint Luke's Cancer Institute - Twin Falls

    Twin Falls, Idaho, 83301

  • MGC Hematology Oncology-Union

    Union, South Carolina, 29379

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • The Carle Foundation Hospital

    Urbana, Illinois, 61801

  • PeaceHealth Southwest Medical Center

    Vancouver, Washington, 98664

  • Providence Saint Mary Regional Cancer Center

    Walla Walla, Washington, 99362

  • Epic Care Cyberknife Center

    Walnut Creek, California, 94597

  • South Pointe Hospital

    Warrensville Heights, Ohio, 44122

  • Illinois CancerCare - Washington

    Washington, Illinois, 61571

  • Mercy Hospital Washington

    Washington, Missouri, 63090

  • Methodist West Hospital

    West Des Moines, Iowa, 50266-7700

  • Mercy Medical Center-West Lakes

    West Des Moines, Iowa, 50266

  • Good Samaritan Hospital Medical Center

    West Islip, New York, 11795

  • University of Kansas Hospital-Westwood Cancer Center

    Westwood, Kansas, 66205

  • UPMC Susquehanna

    Williamsport, Pennsylvania, 17701

  • Providence Regional Cancer System-Yelm

    Yelm, Washington, 98597

  • UPMC Memorial

    York, Pennsylvania, 17408

  • Rush-Copley Healthcare Center

    Yorkville, Illinois, 60560

Other trials in United States

About this study

Official title: A Phase II Trial of Sacituzumab Govitecan (IMMU-132) (NSC #820016) for Patients With HER2-Negative Breast Cancer and Brain Metastases

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.

Read the 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.

IV. 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.

Being tested
Sacituzumab Govitecan
Medical subject headings
Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sacituzumab GovitecanBiological

    Also called hRS7-SN38 Antibody Drug Conjugate, IMMU-132, RS7-SN38, Sacituzumab Govitecan-hziy

    Given IV

Study groups in NCT04647916
Study groupRoleWhat they receive
Treatment (sacituzumab govitecan)ExperimentalPatients 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.
Receives: Biological: Sacituzumab Govitecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR)

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

    Measured: Up to 2 years

Secondary outcomes (3)

  1. Overall survival

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

    Measured: From date of registration to date of death due to any cause, assessed up to 2 years

  2. Progression-free survival

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

    Measured: 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

  3. Incidence of adverse events

    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.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2020
  2. Study start8 Jun 2021
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04647916
Sponsor's protocol ID
S2007
Other IDs
NCI-2020-07706, S2007, S2007, U10CA180888
Status last verified
May 2026
First submitted
23 Nov 2020
Last updated
6 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Kwapisz D. Sacituzumab Govitecan-hziy in Breast Cancer. Am J Clin Oncol. 2022 Jul 1;45(7):279-285. doi: 10.1097/COC.0000000000000919. Epub 2022 May 12.

    PubMed 35728046

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sacituzumab Govitecan in people with Anatomic Stage IV Breast Cancer AJCC v8 and Invasive Breast Carcinoma, run by SWOG Cancer Research Network at 296 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 296 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04647916, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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