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RECRUITING Phase 2 ClinicalTrials.gov

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) • ClinicalTrials.gov ID: NCT06126276

Registry updated: 2026-10-19
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Description

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.

Interventions

  • Biopsy Procedure (Procedure)
    Undergo tumor biopsy
  • Biospecimen Collection (Procedure)
    Undergo collection of blood samples
  • Computed Tomography (Procedure)
    Undergo CT scan
  • Echocardiography Test (Procedure)
    Undergo ECHO
  • Magnetic Resonance Imaging (Procedure)
    Undergo MRI
  • Multigated Acquisition Scan (Procedure)
    Undergo MUGA
  • Neratinib Maleate (Drug)
    Given PO
  • Palbociclib (Drug)
    Given PO

Eligibility criteria

Inclusion Criteria: * Patient must have enrolled onto EAY191 and must have been given a treatment assignment to ComboMATCH to EAY191-N5 based on the presence of an actionable mutation as defined in EAY191 * Patients must have a HER2 amplified solid tumor except breast cancer. * If IHC is 0 or 1+, patient (pt) is NOT ELIGIBLE regardless of in situ hybridization (ISH)/FISH or next generation sequencing (NGS) status * If IHC is 3+, pt IS ELIGIBLE regardless of ISH/FISH or NGS status * If IHC is 2+, ISH/FISH OR NGS must be positive for the patient to be ELIGIBLE. Otherwise, pt is NOT ELIGIBLE * If IHC is unknown and… * ISH/FISH is positive, independent of NGS results, the patient IS ELIGIBLE * ISH/FISH is negative and NGS positive with ≥ 7 copies, the patient IS ELIGIBLE * Patients must have recurrent or persistent disease * No known evidence of RB1 loss or deletion including copy number loss or deleterious mutation * 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) * Patients must have measurable disease based on RECIST 1.1. A second measurable lesion outside of the biopsiable lesion is required * Patients with treated brain metastases are eligible if follow up brain imaging after central nervous system (CNS) directed therapy shows no evidence of progression for 3 months or more and patient is not on steroids and is asymptomatic * No known leptomeningeal disease * Patients may have received up to 5 prior lines of systemic therapy * Prior therapy with trastuzumab or pertuzumab, either alone or in combination, antibody drug conjugates (ADC) such as DS8201a or T-DM1 is allowed * No prior therapy with HER2 targeting tyrosine kinase inhibitors (TKI) such as neratinib or tucatinib * No prior therapy with CDK4/6 inhibition * No cancer directed therapy within 3 weeks prior to registration. For oral therapy, the washout can be reduced to greater than or equal to 5 half lives of the drug. No HER2 targeting ADCs within 30 days prior to registration * Age ≥ 18 * Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2 * Not pregnant and not nursing * Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3 * Platelets ≥ 100,000 cells/mm\^3 * Hemoglobin ≥ 9 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin (Hgb) ≥ 9 g/dl is acceptable) * Creatinine clearance (CrCL) of ≥ 30 mL/min by the Cockcroft-Gault formula * Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional upper limit of normal (ULN) * 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 * No active infection requiring parenteral antibiotics * No current evidence of intra-abdominal abscess, abdominal/pelvic fistula (not diverted), gastrointestinal perforation, gastrointestinal (GI) obstruction, and/or need for drainage nasogastric or gastrostomy tube * No current evidence of malabsorption or chronic diarrhea or any other significant gastro-intestinal disease (e.g gastrectomy, ileal bypass, Crohn's disease, gastroparesis), associated with moderate to severe diarrhea (grade 2 or more) or inability to tolerate oral therapy * No lung disease causing dyspnea at rest * No interstitial lung disease with ongoing signs and symptoms at the time of registration * No history of allergic reaction to the study agents, compound of similar chemical or biologic composition of the study agents or any of their excipients

Conditions

Malignant Female Reproductive System Neoplasm Malignant Solid Neoplasm Recurrent Malignant Female Reproductive System Neoplasm Recurrent Malignant Solid Neoplasm

Locations

  • 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
  • University of Miami Sylvester Comprehensive Cancer Center at Sole Mia — North 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
  • CommonSpirit Saint Joseph Medical Center - East Lexington — 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
  • Minnesota Oncology - Edina — Edina, 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 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
  • University of New Mexico Cancer Center — Albuquerque, New Mexico, United States
  • Roswell Park Cancer Institute — Buffalo, New York, United States
  • State University of New York Upstate Medical University — Syracuse, New York, United States
  • Roswell Park Amherst Center — Williamsville, 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
  • Oregon Health and Science University — 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
  • UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
  • UPMC-Passavant Hospital — Pittsburgh, Pennsylvania, United States
  • Asplundh Cancer Pavilion — Willow Grove, Pennsylvania, United States
  • Women and Infants Hospital — Providence, Rhode Island, 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
  • Parkland Memorial Hospital — Dallas, Texas, United States
  • UT Southwestern/Simmons Cancer Center-Dallas — Dallas, Texas, United States
  • UT Southwestern/Simmons Cancer Center-Fort Worth — Fort Worth, Texas, United States
  • UT MD Anderson Cancer Center — Houston, Texas, United States
  • UT Southwestern Clinical Center at Richardson/Plano — Richardson, 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
  • Carilion Roanoke Memorial Hospital — Roanoke, Virginia, United States
  • Swedish Cancer Institute-Edmonds — Edmonds, Washington, United States
  • Swedish Cancer Institute-Issaquah — Issaquah, Washington, 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
  • Centro Comprensivo de Cancer de UPR — San Juan, Puerto Rico
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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