Testing the Use of Fulvestrant and Binimetinib Targeted Treatment for NF1 Mutation in Hormone Receptor-Positive Metastatic Breast Cancer (A ComboMATCH Treatment Trial)

NCT ID: NCT05554354

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-13
• Study Completion Date: 2025-04-04

Brief Summary

This phase II ComboMATCH treatment trial compares the usual treatment alone (fulvestrant) to using binimetinib plus the usual treatment in patients with hormone receptor positive breast cancer that has spread from where it first started to other places in the body (metastatic) and has an NF1 genetic change. Fulvestrant is a hormonal therapy that binds to estrogen receptors in tumor cells, resulting in estrogen receptor destruction and decreased estrogen binding, which may inhibit the growth of estrogen-sensitive tumor cells. Binimetinib is a targeted therapy that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The addition of binimetinib to fulvestrant in breast cancers with an NF1 genetic change could increase the percentage of tumors that shrink as well as lengthen the time that the tumors remain stable (without progression) as compared to fulvestrant alone.

Detailed Description

PRIMARY OBJECTIVES:

I. To determine whether the combination of fulvestrant and binimetinib improves progression-free survival (PFS) compared to treatment with fulvestrant alone in patients not previously treated with fulvestrant. (Cohort 1) II. To determine whether overall response rate (ORR) within 4 months in patients who have previously progressed on a fulvestrant-containing regimen is greater than 10%, as a historical comparison, when these patients receive combination fulvestrant and binimetinib therapy. (Cohort 2)

SECONDARY OBJECTIVES:

I. To estimate ORR at any time after the start of the treatment for Cohort 2 and separately for the two arms in Cohort 1.

II. To estimate PFS distribution in Cohort 2. III. To estimate clinical benefit rate separately for the two arms in Cohort 1 and Cohort 2.

IV. To determine the safety and toxicity profile in both cohorts. V. To estimate the overall survival (OS) in both cohorts. VI. Collect tissue and provide it to the ComboMATCH Registration Protocol to assess concordance between the diagnostic tumor mutation profile generated by the Designated Laboratories, the pre-treatment biopsy mutation profile, and the pre-treatment circulating tumor deoxyribonucleic acid (DNA) (ctDNA) mutation profile from plasma, as described in ComboMATCH Registration Protocol. For this treatment substudy, the outcome objective will be to report the proportion of cases providing sufficient tissue for that integrated scientific activity in the ComboMATCH Registration Protocol.

EXPLORATORY BIOMARKER OBJECTIVES:

I. To analyze the cell-free (cf)DNA at progression to determine the changes in cfDNA profile in order to understand blood-based mutation dynamics.

II. To analyze RNAseq at progression to determine potential pathways that are altered that may contribute to the sensitivity/resistance.

III. To discover/detect novel biomarkers using microscaled proteogenomics by analyzing the proteins and phosphor-proteins along with genomics to determine potential pathways that may correlate with the response to the combination treatment.

IV. To detect the loss of NF1, using immunohistochemistry staining to precisely measure the level of the NF1 protein.

V. To determine the variant allele frequency (VAF) of mutant NF1 measuring by using droplet digital polymerase chain reaction (ddPCR) for the targeted NF1 gene level.

OUTLINE: Patients who are fulvestrant naive are assigned to Cohort I, while patients who are fulvestrant resistant are assigned to Cohort II.

COHORT I: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive fulvestrant intramuscularly (IM) on day 1 and day 15 of cycle 1 and day 1 of subsequent cycles and binimetinib orally (PO) twice daily (BID) on days 15 to 28 of cycle 1 and day 1 through 28 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo a computed tomography (CT), magnetic resonance imaging (MRI), or bone scan, echocardiography (ECHO) or multi-gated acqusition scan (MUGA), and tumor biopsy, as well as possible blood sample collection during screening and on study.

ARM II: Patients receive fulvestrant IM on day 1 and day 15 of cycle 1 and day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who progress on fulvestrant alone may migrate to cohort II if they meet the migration eligibility criteria. Patients not willing to migrate to cohort II will have further therapy at the investigator's discretion. Patients undergo a CT, MRI, or bone scan and tumor biopsy, as well as ECHO or MUGA and possible blood sample collection during screening and on study.

COHORT II: Patients receive fulvestrant IM on day 1 of each cycle and binimetinib PO BID on days 15-28 of cycle 1 and day 1 through 28 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo a CT, MRI, or bone scan, ECHO or MUGA and tumor biopsy, as well as possible blood sample collection during screening and on study.

Upon completion of study treatment patients are followed up every 6 months for 5 years.

Conditions

Anatomic Stage IV Breast Cancer AJCC v8; Metastatic HER2-Negative Breast Carcinoma; Metastatic Hormone Receptor-Positive Breast Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort I (Arm I) (fulvestrant, binimetinib)

Patients receive fulvestrant IM on day 1 and day 15 of cycle 1 and day 1 of subsequent cycles and binimetinib PO BID on days 15 to 28 of cycle 1 and day 1 through 28 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT, MRI, or bone scan, ECHO or MUGA, and tumor biopsy, as well as possible blood sample collection during screening and on study.

Group Type: EXPERIMENTAL

Binimetinib

Intervention Type: DRUG

Given PO

Biopsy Procedure

Intervention Type: PROCEDURE

Undergo tumor biopsy

Biospecimen Collection

Intervention Type: PROCEDURE

Undergo blood sample collection

Bone Scan

Intervention Type: PROCEDURE

Undergo bone scan

Computed Tomography

Intervention Type: PROCEDURE

Undergo CT scan

Echocardiography Test

Intervention Type: PROCEDURE

Undergo ECHO

Fulvestrant

Intervention Type: DRUG

Given IM

Magnetic Resonance Imaging

Intervention Type: PROCEDURE

Undergo MRI

Multigated Acquisition Scan

Intervention Type: PROCEDURE

Undergo MUGA

Cohort I (Arm II)

Patients receive fulvestrant IM on day 1 and day 15 of cycle 1 and day 1 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who progress on fulvestrant alone may migrate to cohort II if they meet the migration eligibility criteria. Patients not willing to migrate to cohort II will have further therapy at the investigator's discretion. Patients undergo a CT, MRI, or bone scan and tumor biopsy, as well as ECHO or MUGA and possible blood sample collection during screening and on study.

Group Type: ACTIVE_COMPARATOR

Biopsy Procedure

Intervention Type: PROCEDURE

Undergo tumor biopsy

Biospecimen Collection

Intervention Type: PROCEDURE

Undergo blood sample collection

Bone Scan

Intervention Type: PROCEDURE

Undergo bone scan

Computed Tomography

Intervention Type: PROCEDURE

Undergo CT scan

Echocardiography Test

Intervention Type: PROCEDURE

Undergo ECHO

Fulvestrant

Intervention Type: DRUG

Given IM

Magnetic Resonance Imaging

Intervention Type: PROCEDURE

Undergo MRI

Multigated Acquisition Scan

Intervention Type: PROCEDURE

Undergo MUGA

Cohort II (fulvestrant, binimetinib)

Patients receive fulvestrant IM on day 1 of each cycle and binimetinib PO BID on days 15-28 of cycle 1 and day 1 through 28 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo a CT, MRI, or bone scan, ECHO or MUGA and tumor biopsy, as well as possible blood sample collection during screening and on study.

Group Type: EXPERIMENTAL

Binimetinib

Intervention Type: DRUG

Given PO

Biopsy Procedure

Intervention Type: PROCEDURE

Undergo tumor biopsy

Biospecimen Collection

Intervention Type: PROCEDURE

Undergo blood sample collection

Bone Scan

Intervention Type: PROCEDURE

Undergo bone scan

Computed Tomography

Intervention Type: PROCEDURE

Undergo CT scan

Echocardiography Test

Intervention Type: PROCEDURE

Undergo ECHO

Fulvestrant

Intervention Type: DRUG

Given IM

Magnetic Resonance Imaging

Intervention Type: PROCEDURE

Undergo MRI

Multigated Acquisition Scan

Intervention Type: PROCEDURE

Undergo MUGA

Interventions

Binimetinib

Given PO

Intervention Type: DRUG

Biopsy Procedure

Undergo tumor biopsy

Intervention Type: PROCEDURE

Biospecimen Collection

Undergo blood sample collection

Intervention Type: PROCEDURE

Bone Scan

Undergo bone scan

Intervention Type: PROCEDURE

Computed Tomography

Undergo CT scan

Intervention Type: PROCEDURE

Echocardiography Test

Undergo ECHO

Intervention Type: PROCEDURE

Fulvestrant

Given IM

Intervention Type: DRUG

Magnetic Resonance Imaging

Undergo MRI

Intervention Type: PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

Intervention Type: PROCEDURE

Other Intervention Names

ARRY 162; ARRY 438162; ARRY-162; ARRY-438162; ARRY162; ARRY438162; MEK 162; MEK-162; MEK162; Mektovi; Biopsy; BIOPSY_TYPE; Bx; Biological Sample Collection; Biospecimen Collected; Specimen Collection; Bone Scintigraphy; CAT; CAT Scan; Computed Axial Tomography; Computerized Axial Tomography; Computerized axial tomography (procedure); Computerized Tomography; Computerized Tomography (CT) scan; CT; CT Scan; tomography; EC; Echocardiography; Faslodex; Faslodex(ICI 182,780); ICI 182,780; ICI 182780; ICI-182780; ICI182780; ZD 9238; ZD-9238; ZD9238; Magnetic Resonance; Magnetic Resonance Imaging (MRI); Magnetic resonance imaging (procedure); Magnetic Resonance Imaging Scan; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; MR; MR Imaging; MRI; MRI Scan; MRIs; NMR Imaging; NMRI; Nuclear Magnetic Resonance Imaging; sMRI; Structural MRI; Blood Pool Scan; Equilibrium Radionuclide Angiography; Gated Blood Pool Imaging; Gated Heart Pool Scan; MUGA; MUGA Scan; Multi-Gated Acquisition Scan; Radionuclide Ventriculogram Scan; Radionuclide Ventriculography; RNV Scan; RNVG; SYMA Scanning; Synchronized Multigated Acquisition Scanning

Eligibility Criteria

Inclusion Criteria

• Patient must have enrolled onto EAY191 and must have been given a treatment assignment to ComboMATCH to EAY191-N2 based on the presence of an actionable mutation as defined in EAY191
• The patient must be enrolled on the ComboMATCH Master Registration Trial EAY191

• Note: Patients must fulfill all eligibility criteria outlined in the ComboMATCH Registration Trial EAY191 at the time of registration to EAY191-N2. This includes submission of next-generation sequencing (NGS) data from one of the National Cancer Institute (NCI) credentialed designated laboratories for all potential patients prior to treatment trial assignment. Copy number and allele frequency cutoff as per the Registration protocol
• Patients must have disease that can be safely biopsied and agree to a pre-treatment biopsy or, if disease cannot be safely biopsied, have archival tissue available from within 12 months prior to the date of registration on the ComboMATCH registration trial (EAY191)

• Please note the current actionable marker of interest (aMOI)/actionable alteration list for this treatment trial can be found on the Cancer Trial Support Unit (CTSU) ComboMATCH Registration protocol page
• Please note novel/Dynamic aMOI can be submitted for review per the process described in the ComboMATCH Registration protocol
• A COMBOMATCH TREATMENT TRIAL EAY191-N2 ELIGIBILITY CRITERIA:
• The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information
• Age >= 18
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Histologically or cytologically confirmed invasive breast carcinoma
• Confirmed metastatic disease by either imaging or tissue diagnosis
• Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and one additional lesion that can be biopsied (primary, metastatic both allowed)
• Patients must have inactivating or inferred inactivating NF1 alterations detected in tumor as determined by the ComboMATCH screening assessment
• The tumor must have been determined to be estrogen receptor (ER) and/or progesterone receptor (PgR) positive assessed by current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guideline recommendations for hormone receptor testing. Patients with >= 1% ER or PgR staining by immunohistochemistry (IHC) are considered positive
• The tumor must have been determined to be HER2-negative by current ASCO/CAP guidelines
• Prior use of CDK4/6 inhibitor(i) is required
• Prior use of fulvestrant regardless of duration is allowed and will determine treatment assignment
• Up to one line of chemotherapy in metastatic setting is allowed
• Absolute neutrophil count >= 1,500/mm^3
• Platelet count >= 100,000/ mm^3
• Hemoglobin level >= 10 g/dL
• Creatinine clearance (CrCL) of ≥ 30 mL/min by the Cockcroft-Gault formula
• Total bilirubin level =< institutional upper limit of normal
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be =< 5.0 x ULN
• For patients who will be assigned to Cohort 2 (fulvestrant-resistant), a left ventricular ejection fraction (LVEF) assessment must be performed within 12 weeks prior to registration. The LVEF must be >= 50% regardless of the cardiac imaging facility's lower limit of normal. (LVEF assessment performed by echocardiogram is preferred; however, MUGA scan may be substituted based on institutional/situational preferences)
• Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
• Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial
• ELIGIBILITY CRITERIA FOR COHORT 1, TREATMENT REGIMEN 2 PATIENTS WHO MIGRATE TO COHORT 2: Cohort migration: Patients treated with control treatment fulvestrant who experience disease progression may be eligible to migrate to Cohort 2 and receive combination treatment with binimetinib and fulvestrant. Patients who choose to do so must meet laboratory values and performance status requirements below and should begin treatment within 28 days
• PATIENTS WHO MIGRATE TO COHORT 2: Patient's willingness to migrate to Cohort 2 affirmed
• PATIENTS WHO MIGRATE TO COHORT 2: The patient must have an ECOG performance status of 0-2
• PATIENTS WHO MIGRATE TO COHORT 2: Absolute neutrophil count >= 1,500/mm^3
• PATIENTS WHO MIGRATE TO COHORT 2: Platelet count >= 100,000/ mm^3
• PATIENTS WHO MIGRATE TO COHORT 2: Hemoglobin level >= 10 g/dL
• PATIENTS WHO MIGRATE TO COHORT 2: Total bilirubin level =< institutional upper limit of normal (ULN)
• PATIENTS WHO MIGRATE TO COHORT 2: AST and ALT must be =< 5.0 x ULN
• PATIENTS WHO MIGRATE TO COHORT 2: Creatinine clearance (CrCL) of ≥30 mL/min by the Cockcroft-Gault formula
• PATIENTS WHO MIGRATE TO COHORT 2: A LVEF performed within the last 3 months must be >= 50% regardless of the cardiac imaging facility's lower limit of normal (LVEF assessment performed by echocardiogram is preferred; however, MUGA scan may be substituted based on institutional/situational preferences)
• PATIENTS WHO MIGRATE TO COHORT 2: Pregnancy test according to institutional standards must be negative (for patients of childbearing potential only)

Exclusion Criteria

• Concurrent anticancer therapy
• Active autoimmune disease requiring systemic treatment within the past 3 months, documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
• Active brain metastasis. Brain metastases that have been stable for at least 1 month after completion of treatment are not an exclusion criterion
• History of or evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment/central serous, chorioretinopathy (CSCR), retinal vein occlusion (RVO), or neovascular macular degeneration
• Patients will be excluded if they currently have the following risk factors for RVO that are documented prior to the enrollment:

• Known uncontrolled glaucoma with intra-ocular pressures >= 21 mmHg
• Known serum cholesterol >= grade 2.
• Known hypertriglyceridemia >= grade 2
• Known hyperglycemia (fasting) >= grade 2
• Patients with baseline QT corrected for heart rate (QTc) > 500 ms, either induced by medication or congenital long QT syndrome will be excluded due to known side effects of binimetinib
• Nervous system disorder (paresthesia, peripheral motor neuropathy, or peripheral sensory neuropathy) >= grade 2
• Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
• Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
• Other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements or interfere with interpretation of study results
• Pregnancy or lactation at the time of registration or intention to become pregnant during the study (Note: Pregnancy testing according to institutional standards for patients of childbearing potential)

• For binimetinib, highly effective contraception should be used for at least 30 days after the last dose, and patients should not breastfeed for 3 days after the last dose
• For fulvestrant, highly effective contraception should be used for 1 year after the last dose, and patients should not breastfeed for 1 year after the last dose
• Use of any investigational product within 30 days prior to study entry
• INELIGIBILITY CRITERIA FOR COHORT 1, TREATMENT REGIMEN 2 PATIENTS WHO MIGRATE TO COHORT 2
• PATIENTS WHO MIGRATE TO COHORT 2: Not a candidate for binimetinib in the opinion of the treating investigator

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NRG Oncology

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bora Lim

Role: PRINCIPAL_INVESTIGATOR

CenterThe University of Texas MD Anderson Cancer Center

Locations

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Kingman Regional Medical Center

Kingman, Arizona, United States

PCR Oncology

Arroyo Grande, California, United States

Epic Care-Dublin

Dublin, California, United States

Epic Care Partners in Cancer Care

Emeryville, California, United States

Contra Costa Regional Medical Center

Martinez, California, United States

Saint Joseph Hospital - Orange

Orange, California, United States

Saint John's Cancer Institute

Santa Monica, California, United States

Epic Care Cyberknife Center

Walnut Creek, California, United States

UM Sylvester Comprehensive Cancer Center at Aventura

Aventura, Florida, United States

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

UM Sylvester Comprehensive Cancer Center at Kendall

Miami, Florida, United States

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, United States

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States

Saint Luke's Cancer Institute - Boise

Boise, Idaho, United States

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, United States

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, United States

Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, United States

Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, United States

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, United States

Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, United States

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, United States

Kootenai Clinic Cancer Services - Sandpoint

Sandpoint, Idaho, United States

Saint Luke's Cancer Institute - Twin Falls

Twin Falls, Idaho, United States

Advocate Good Shepherd Hospital

Barrington, Illinois, United States

Northwestern University

Chicago, Illinois, United States

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, United States

Advocate Illinois Masonic Medical Center

Chicago, Illinois, United States

AMG Crystal Lake - Oncology

Crystal Lake, Illinois, United States

Carle at The Riverfront

Danville, Illinois, United States

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, United States

Carle Physician Group-Effingham

Effingham, Illinois, United States

Advocate Sherman Hospital

Elgin, Illinois, United States

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, United States

Advocate South Suburban Hospital

Hazel Crest, Illinois, United States

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, United States

AMG Libertyville - Oncology

Libertyville, Illinois, United States

Condell Memorial Hospital

Libertyville, Illinois, United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States

Advocate Christ Medical Center

Oak Lawn, Illinois, United States

Northwestern Medicine Orland Park

Orland Park, Illinois, United States

Advocate Lutheran General Hospital

Park Ridge, Illinois, United States

Memorial Hospital East

Shiloh, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, United States

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, United States

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, United States

Mercy Medical Center - Des Moines

Des Moines, Iowa, United States

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States

Lafayette Family Cancer Center-EMMC

Brewer, Maine, United States

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, United States

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

UPMC Western Maryland

Cumberland, Maryland, United States

Tufts Medical Center

Boston, Massachusetts, United States

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, United States

Trinity Health Medical Center - Brighton

Brighton, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, United States

Trinity Health Medical Center - Canton

Canton, Michigan, United States

Chelsea Hospital

Chelsea, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, United States

Corewell Health Dearborn Hospital

Dearborn, Michigan, United States

Corewell Health Farmington Hills Hospital

Farmington Hills, Michigan, United States

Cancer Hematology Centers - Flint

Flint, Michigan, United States

Genesee Hematology Oncology PC

Flint, Michigan, United States

Genesys Hurley Cancer Institute

Flint, Michigan, United States

Hurley Medical Center

Flint, Michigan, United States

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, United States

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, United States

Henry Ford Saint John Hospital - Macomb Medical

Macomb, Michigan, United States

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, United States

MyMichigan Medical Center Saginaw

Saginaw, Michigan, United States

Oncology Hematology Associates of Saginaw Valley PC

Saginaw, Michigan, United States

MyMichigan Medical Center Tawas

Tawas City, Michigan, United States

Corewell Health Beaumont Troy Hospital

Troy, Michigan, United States

Saint Mary's Oncology/Hematology Associates of West Branch

West Branch, Michigan, United States

Huron Gastroenterology PC

Ypsilanti, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, United States

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, United States

Mercy Hospital

Coon Rapids, Minnesota, United States

Essentia Health - Deer River Clinic

Deer River, Minnesota, United States

Essentia Health Cancer Center

Duluth, Minnesota, United States

Fairview Southdale Hospital

Edina, Minnesota, United States

Essentia Health Hibbing Clinic

Hibbing, Minnesota, United States

Saint John's Hospital - Healtheast

Maplewood, Minnesota, United States

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States

Regions Hospital

Saint Paul, Minnesota, United States

United Hospital

Saint Paul, Minnesota, United States

Essentia Health Sandstone

Sandstone, Minnesota, United States

Essentia Health Virginia Clinic

Virginia, Minnesota, United States

Gulfport Memorial Hospital

Gulfport, Mississippi, United States

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, United States

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Siteman Cancer Center-South County

St Louis, Missouri, United States

Siteman Cancer Center at Christian Hospital

St Louis, Missouri, United States

Community Hospital of Anaconda

Anaconda, Montana, United States

Billings Clinic Cancer Center

Billings, Montana, United States

Bozeman Health Deaconess Hospital

Bozeman, Montana, United States

Benefis Sletten Cancer Institute

Great Falls, Montana, United States

Logan Health Medical Center

Kalispell, Montana, United States

Community Medical Center

Missoula, Montana, United States

OptumCare Cancer Care at Seven Hills

Henderson, Nevada, United States

OptumCare Cancer Care at Charleston

Las Vegas, Nevada, United States

OptumCare Cancer Care at Fort Apache

Las Vegas, Nevada, United States

Montefiore Medical Center-Einstein Campus

The Bronx, New York, United States

Sanford Bismarck Medical Center

Bismarck, North Dakota, United States

Sanford Broadway Medical Center

Fargo, North Dakota, United States

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States

Strecker Cancer Center-Belpre

Belpre, Ohio, United States

Aultman Health Foundation

Canton, Ohio, United States

Miami Valley Hospital South

Centerville, Ohio, United States

Adena Regional Medical Center

Chillicothe, Ohio, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Mount Carmel East Hospital

Columbus, Ohio, United States

The Mark H Zangmeister Center

Columbus, Ohio, United States

Miami Valley Hospital

Dayton, Ohio, United States

Premier Blood and Cancer Center

Dayton, Ohio, United States

Dayton Physician LLC - Englewood

Dayton, Ohio, United States

Miami Valley Hospital North

Dayton, Ohio, United States

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, United States

Miami Valley Cancer Care and Infusion

Greenville, Ohio, United States

Kettering Medical Center

Kettering, Ohio, United States

Fairfield Medical Center

Lancaster, Ohio, United States

Marietta Memorial Hospital

Marietta, Ohio, United States

Memorial Hospital

Marysville, Ohio, United States

Knox Community Hospital

Mount Vernon, Ohio, United States

Licking Memorial Hospital

Newark, Ohio, United States

Mercy Health - Perrysburg Hospital

Perrysburg, Ohio, United States

Southern Ohio Medical Center

Portsmouth, Ohio, United States

Springfield Regional Cancer Center

Springfield, Ohio, United States

Springfield Regional Medical Center

Springfield, Ohio, United States

Mercy Health - Saint Anne Hospital

Toledo, Ohio, United States

Upper Valley Medical Center

Troy, Ohio, United States

Saint Ann's Hospital

Westerville, Ohio, United States

Genesis Healthcare System Cancer Care Center

Zanesville, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Providence Newberg Medical Center

Newberg, Oregon, United States

Saint Alphonsus Cancer Care Center-Ontario

Ontario, Oregon, United States

Providence Willamette Falls Medical Center

Oregon City, Oregon, United States

Providence Portland Medical Center

Portland, Oregon, United States

Providence Saint Vincent Medical Center

Portland, Oregon, United States

UPMC Altoona

Altoona, Pennsylvania, United States

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, United States

UPMC Hillman Cancer Center Erie

Erie, Pennsylvania, United States

UPMC Cancer Centers - Arnold Palmer Pavilion

Greensburg, Pennsylvania, United States

UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

Mechanicsburg, Pennsylvania, United States

Riddle Memorial Hospital

Media, Pennsylvania, United States

UPMC Hillman Cancer Center - Monroeville

Monroeville, Pennsylvania, United States

Paoli Memorial Hospital

Paoli, Pennsylvania, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

UPMC-Passavant Hospital

Pittsburgh, Pennsylvania, United States

Asplundh Cancer Pavilion

Willow Grove, Pennsylvania, United States

Lankenau Medical Center

Wynnewood, Pennsylvania, United States

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, United States

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, United States

M D Anderson Cancer Center

Houston, Texas, United States

Virginia Cancer Institute

Richmond, Virginia, United States

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, United States

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, United States

VCU Community Memorial Health Center

South Hill, Virginia, United States

Swedish Cancer Institute-Edmonds

Edmonds, Washington, United States

Swedish Cancer Institute-Issaquah

Issaquah, Washington, United States

Valley Medical Center

Renton, Washington, United States

North Star Lodge Cancer Center at Yakima Valley Memorial Hospital

Yakima, Washington, United States

Duluth Clinic Ashland

Ashland, Wisconsin, United States

Aurora Cancer Care-Southern Lakes VLCC

Burlington, Wisconsin, United States

Aurora Saint Luke's South Shore

Cudahy, Wisconsin, United States

Aurora Health Care Germantown Health Center

Germantown, Wisconsin, United States

Aurora Cancer Care-Grafton

Grafton, Wisconsin, United States

Aurora BayCare Medical Center

Green Bay, Wisconsin, United States

Aurora Cancer Care-Kenosha South

Kenosha, Wisconsin, United States

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, United States

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Madison, Wisconsin, United States

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, United States

Aurora Bay Area Medical Group-Marinette

Marinette, Wisconsin, United States

Aurora Cancer Care-Milwaukee

Milwaukee, Wisconsin, United States

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, United States

Aurora Sinai Medical Center

Milwaukee, Wisconsin, United States

Vince Lombardi Cancer Clinic - Oshkosh

Oshkosh, Wisconsin, United States

Aurora Cancer Care-Racine

Racine, Wisconsin, United States

Vince Lombardi Cancer Clinic-Sheboygan

Sheboygan, Wisconsin, United States

Aurora Medical Center in Summit

Summit, Wisconsin, United States

Vince Lombardi Cancer Clinic-Two Rivers

Two Rivers, Wisconsin, United States

Aurora Cancer Care-Milwaukee West

Wauwatosa, Wisconsin, United States

Aurora West Allis Medical Center

West Allis, Wisconsin, United States

Puerto Rico Hematology Oncology Group

Bayamón, , Puerto Rico

Doctors Cancer Center

Manatí, , Puerto Rico

Centro Comprensivo de Cancer de UPR

San Juan, , Puerto Rico

PROncology

San Juan, , Puerto Rico

Countries

United States; Puerto Rico

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

NCI-2022-07265

Identifier Type: REGISTRY

Identifier Source: secondary_id

EAY191-N2

Identifier Type: OTHER

Identifier Source: secondary_id

EAY191-N2

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA180868

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2022-07265

Identifier Type: -

Identifier Source: org_study_id