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Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)
Sponsor: National Cancer Institute (NCI)
Summary
This phase II ComboMATCH treatment trial compares the effect of neratinib to the combination of neratinib and palbociclib in treating patients with HER2 positive solid tumors. Neratinib and palbociclib are in a class of medications called kinase inhibitors. They work by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of tumor cells. Giving neratinib and palbociclib in combination may shrink or stabilize cancers that over-express a specific biomarker called HER2.
Official title: A Randomized Trial of Neratinib, A Pan-ERBB Inhibitor, Alone or in Combination With Palbociclib, a CDK4/6 Inhibitor, in Patients With HER2+ Gynecologic Cancers and Other Solid Tumors: A ComboMATCH Treatment Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2024-05-07
Completion Date
2027-02-20
Last Updated
2026-04-09
Healthy Volunteers
No
Conditions
Interventions
Biopsy Procedure
Undergo tumor biopsy
Biospecimen Collection
Undergo collection of blood samples
Computed Tomography
Undergo CT scan
Echocardiography Test
Undergo ECHO
Magnetic Resonance Imaging
Undergo MRI
Multigated Acquisition Scan
Undergo MUGA
Neratinib Maleate
Given PO
Palbociclib
Given PO
Locations (182)
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, United States
Alaska Women's Cancer Care
Anchorage, Alaska, United States
UC San Diego Health System - Encinitas
Encinitas, California, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
The Angeles Clinic and Research Institute - West Los Angeles Office
Los Angeles, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
UC San Diego Medical Center - Hillcrest
San Diego, 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 Coral Springs
Coral Springs, Florida, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, 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
SIH Cancer Institute
Carterville, Illinois, United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, United States
University of Illinois
Chicago, Illinois, United States
Carle at The Riverfront
Danville, Illinois, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
Carle Physician Group-Effingham
Effingham, Illinois, United States
Crossroads Cancer Center
Effingham, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, United States
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States
Carle BroMenn Medical Center
Normal, Illinois, United States
Carle Cancer Institute Normal
Normal, Illinois, United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, United States
Mercyhealth Cancer Institute - Rockford
Rockford, Illinois, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Springfield Clinic
Springfield, Illinois, United States
Springfield Memorial Hospital
Springfield, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
Woodland Cancer Care Center
Michigan City, Indiana, 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
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, United States
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, United States
Saint Joseph Hospital East
Lexington, Kentucky, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States
Harold Alfond Center for Cancer Care
Augusta, Maine, United States
Lafayette Family Cancer Center-EMMC
Brewer, Maine, United States
MaineHealth Maine Medical Center- Scarborough
Scarborough, Maine, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
National Institutes of Health Clinical Center
Bethesda, Maryland, United States
UPMC Western Maryland
Cumberland, Maryland, 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 IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, United States
Corewell Health Dearborn Hospital
Dearborn, Michigan, United States
OSF Saint Francis Hospital and Medical Group
Escanaba, 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
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, United States
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, United States
Corewell Health Beaumont Troy Hospital
Troy, 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
Essentia Health - Deer River Clinic
Deer River, Minnesota, United States
Essentia Health Cancer Center
Duluth, Minnesota, United States
Essentia Health Hibbing Clinic
Hibbing, Minnesota, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Essentia Health Sandstone
Sandstone, Minnesota, United States
Essentia Health Virginia Clinic
Virginia, Minnesota, United States
Saint Francis Medical Center
Cape Girardeau, 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
Jersey City Medical Center
Jersey City, New Jersey, United States
Monmouth Medical Center Southern Campus
Lakewood, New Jersey, United States
Monmouth Medical Center
Long Branch, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Community Medical Center
Toms River, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
State University of New York Upstate Medical University
Syracuse, New York, United States
Cone Health MedCenter Asheboro
Asheboro, North Carolina, United States
Cone Health Cancer Center at Alamance Regional
Burlington, North Carolina, United States
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, United States
Cone Health Cancer Center
Greensboro, North Carolina, United States
Cone Health Cancer Center at Drawbridge Parkway
Greensboro, North Carolina, United States
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina, United States
Duke Women's Cancer Care Raleigh
Raleigh, North Carolina, United States
Annie Penn Memorial Hospital
Reidsville, North Carolina, 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
OhioHealth O'Bleness Hospital
Athens, Ohio, United States
Miami Valley Hospital South
Centerville, Ohio, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Grant Medical Center
Columbus, Ohio, United States
Doctors Hospital
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
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, United States
Grady Memorial Hospital
Delaware, Ohio, United States
Columbus Oncology and Hematology Associates
Dublin, Ohio, United States
Dublin Methodist Hospital
Dublin, 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
OhioHealth Mansfield Hospital
Mansfield, Ohio, United States
OhioHealth Marion General Hospital
Marion, Ohio, United States
OhioHealth Pickerington Methodist Hospital
Pickerington, Ohio, United States
Upper Valley Medical Center
Troy, Ohio, United States
OhioHealth Westerville Medical Campus/Westerville Cancer Center
Westerville, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Saint Alphonsus Cancer Care Center-Ontario
Ontario, 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
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
UPMC Hillman Cancer Center - Monroeville
Monroeville, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
UPMC-Magee Womens Hospital
Pittsburgh, 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
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States
Bristol Regional Medical Center
Bristol, Tennessee, United States
Regional Cancer Center at Johnson City Medical Center
Johnson City, Tennessee, United States
Ballad Health Cancer Care - Kingsport
Kingsport, Tennessee, United States
Wellmont Holston Valley Hospital and Medical Center
Kingsport, Tennessee, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States
M D Anderson Cancer Center
Houston, Texas, United States
Scott and White Memorial Hospital
Temple, Texas, United States
Ballad Health Cancer Care - Bristol
Bristol, Virginia, United States
University of Virginia Cancer Center
Charlottesville, Virginia, United States
Inova Schar Cancer Institute
Fairfax, Virginia, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States
Swedish Medical Center-First Hill
Seattle, Washington, United States
West Virginia University Healthcare
Morgantown, West Virginia, United States
Duluth Clinic Ashland
Ashland, Wisconsin, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, United States
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, United States
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan, Wisconsin, United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, United States
Marshfield Medical Center - Weston
Weston, Wisconsin, United States