Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)

May 30, 2026 updated by: National Cancer Institute (NCI)

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To investigate the efficacy of neratinib plus palbociclib (PD-0332991) compared to neratinib maleate (neratinib) alone in patients with HER2+ gynecologic cancers and HER2+ solid tumors by evaluating progression-free survival (PFS).

SECONDARY OBJECTIVES:

I. To investigate outcome in terms of objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

II. To investigate clinical benefit rate (ORR + stable disease at 16 weeks). III. To evaluate overall (OS) survival. IV. To evaluate the ORR of patients who crossed over from neratinib monotherapy to neratinib-palbociclib combination.

V. To investigate adverse events especially grade 3 and 4 toxicities by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.

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-derived deoxyribonucleic acid (ctDNA) mutation profile from plasma, as described in ComboMATCH Registration Protocol.

EXPLORATORY TRANSLATIONAL OBJECTIVES:

I. To investigate the role of ctDNA-HER2 status at baseline and during follow up to assess if it predicts response to therapy and disease progression and if it does correlate with tumor tissue based HER2 status.

II. To investigate if activation of the pathways of interest (PI3K/mTOR and RB1, CCND1-CDK4/6 CDK and RAS/RAF/MAPK) in tumor tissue as well as blood/ctDNA correlate with response or resistance to therapy.

III. To correlate extent of HER2 amplification with response to treatment and with HER2 expression by immunohistochemistry or fluorescence in situ hybridization (FISH).

IV. To correlate the extent of HER2 amplification with HER2 expression by RNA and protein immunohistochemistry (IHC) analyses and FISH.

V. To correlate expression of Rb1, CCND1, CCNE1, CDK4/6 protein expression with response to treatment.

VI. Assess alteration in RB1-CDK pathway in neratinib resistant patients at time of progression on monotherapy compared to combination neratinib-palbociclib.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive neratinib maleate orally (PO) once daily (QD) on days 1-14 of cycle 0 in the absence of disease progression or unacceptable toxicity. Patients then receive neratinib maleate PO QD on days 1-28 of each subsequent cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience progression may crossover to Arm II. Patients undergo echocardiogram (ECHO) or multi-gated acquisition scan (MUGA) during screening and on study, and computed tomography (CT) or magnetic resonance imaging (MRI) and collection of blood samples throughout the trial. Patients may also undergo tumor biopsy during screening and on study.

ARM II: Patients receive neratinib maleate PO QD on days 1-14 of cycle 0 in the absence of disease progression or unacceptable toxicity. Patients then receive neratinib maleate PO QD on days 1-28 and palbociclib PO QD on days 1-21 of each subsequent cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening and on study, and CT or MRI and collection of blood samples throughout the trial. Patients may also undergo tumor biopsy during screening and on study.

After completion of study treatment, patients are followed up every 3 months for 2 years.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Recruiting
        • Centro Comprensivo de Cancer de UPR
        • Principal Investigator:
          • Luis J. Santos Reyes
        • Contact:
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama at Birmingham Cancer Center
        • Principal Investigator:
          • Rebecca C. Arend
        • Contact:
      • Mobile, Alabama, United States, 36688
        • Recruiting
        • University of South Alabama Mitchell Cancer Institute
        • Contact:
        • Principal Investigator:
          • Ahmed Abdalla
    • Alaska
      • Anchorage, Alaska, United States, 99508
    • California
      • Encinitas, California, United States, 92024
        • Recruiting
        • UC San Diego Health System - Encinitas
        • Contact:
          • Site Public Contact
          • Phone Number: 760-536-7700
        • Principal Investigator:
          • Peter Vu
      • La Jolla, California, United States, 92093
        • Recruiting
        • UC San Diego Moores Cancer Center
        • Contact:
        • Principal Investigator:
          • Peter Vu
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center
        • Principal Investigator:
          • Omid Hamid
        • Contact:
      • Los Angeles, California, United States, 90025
        • Recruiting
        • The Angeles Clinic and Research Institute - West Los Angeles Office
        • Contact:
        • Principal Investigator:
          • Omid Hamid
      • San Diego, California, United States, 92103
        • Recruiting
        • UC San Diego Medical Center - Hillcrest
        • Contact:
        • Principal Investigator:
          • Peter Vu
    • Florida
      • Aventura, Florida, United States, 33180
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Aventura
        • Principal Investigator:
          • Matthew P. Schlumbrecht
        • Contact:
          • Site Public Contact
          • Phone Number: 954-461-2180
      • Coral Gables, Florida, United States, 33146
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Coral Gables
        • Principal Investigator:
          • Matthew P. Schlumbrecht
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
      • Coral Springs, Florida, United States, 33065
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Coral Springs
        • Principal Investigator:
          • Matthew P. Schlumbrecht
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
      • Deerfield Beach, Florida, United States, 33442
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Deerfield Beach
        • Principal Investigator:
          • Matthew P. Schlumbrecht
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
        • Principal Investigator:
          • Matthew P. Schlumbrecht
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
      • Miami, Florida, United States, 33176
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Kendall
        • Principal Investigator:
          • Matthew P. Schlumbrecht
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
      • North Miami, Florida, United States, 33181
        • Recruiting
        • University of Miami Sylvester Comprehensive Cancer Center at Sole Mia
        • Principal Investigator:
          • Matthew P. Schlumbrecht
        • Contact:
      • Plantation, Florida, United States, 33324
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Plantation
        • Principal Investigator:
          • Matthew P. Schlumbrecht
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
    • Idaho
      • Boise, Idaho, United States, 83712
        • Recruiting
        • Saint Luke's Cancer Institute - Boise
        • Principal Investigator:
          • Dan S. Zuckerman
        • Contact:
      • Boise, Idaho, United States, 83706
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Boise
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Caldwell, Idaho, United States, 83605
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Caldwell
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Coeur d'Alene, Idaho, United States, 83814
        • Recruiting
        • Kootenai Health - Coeur d'Alene
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Fruitland, Idaho, United States, 83619
        • Recruiting
        • Saint Luke's Cancer Institute - Fruitland
        • Principal Investigator:
          • Dan S. Zuckerman
        • Contact:
      • Meridian, Idaho, United States, 83642
        • Recruiting
        • Saint Luke's Cancer Institute - Meridian
        • Principal Investigator:
          • Dan S. Zuckerman
        • Contact:
      • Nampa, Idaho, United States, 83687
        • Recruiting
        • Saint Luke's Cancer Institute - Nampa
        • Principal Investigator:
          • Dan S. Zuckerman
        • Contact:
      • Nampa, Idaho, United States, 83687
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Nampa
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Post Falls, Idaho, United States, 83854
        • Recruiting
        • Kootenai Clinic Cancer Services - Post Falls
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Sandpoint, Idaho, United States, 83864
        • Recruiting
        • Kootenai Clinic Cancer Services - Sandpoint
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
    • Illinois
      • Carterville, Illinois, United States, 62918
        • Recruiting
        • SIH Cancer Institute
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois
        • Contact:
          • Site Public Contact
          • Phone Number: 312-355-3046
        • Principal Investigator:
          • Ryan Nguyen
      • Chicago, Illinois, United States, 60612
        • Suspended
        • John H Stroger Jr Hospital of Cook County
      • Danville, Illinois, United States, 61832
        • Recruiting
        • Carle at The Riverfront
        • Contact:
        • Principal Investigator:
          • Maria T. Grosse-Perdekamp
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Cancer Care Specialists of Illinois - Decatur
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Decatur Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Carle Physician Group-Effingham
        • Contact:
        • Principal Investigator:
          • Maria T. Grosse-Perdekamp
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Crossroads Cancer Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Evanston, Illinois, United States, 60201
        • Recruiting
        • NorthShore University HealthSystem-Evanston Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 847-570-2109
        • Principal Investigator:
          • Mary T. Jenkins Vogel
      • Glenview, Illinois, United States, 60026
        • Recruiting
        • NorthShore University HealthSystem-Glenbrook Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 847-570-2109
        • Principal Investigator:
          • Mary T. Jenkins Vogel
      • Highland Park, Illinois, United States, 60035
        • Recruiting
        • NorthShore University HealthSystem-Highland Park Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 847-570-2109
        • Principal Investigator:
          • Mary T. Jenkins Vogel
      • Mattoon, Illinois, United States, 61938
        • Recruiting
        • Carle Physician Group-Mattoon/Charleston
        • Contact:
        • Principal Investigator:
          • Maria T. Grosse-Perdekamp
      • Normal, Illinois, United States, 61761
        • Recruiting
        • Carle BroMenn Medical Center
        • Contact:
        • Principal Investigator:
          • Maria T. Grosse-Perdekamp
      • Normal, Illinois, United States, 61761
        • Recruiting
        • Carle Cancer Institute Normal
        • Contact:
        • Principal Investigator:
          • Maria T. Grosse-Perdekamp
      • O'Fallon, Illinois, United States, 62269
        • Recruiting
        • Cancer Care Center of O'Fallon
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Rockford, Illinois, United States, 61114
        • Recruiting
        • Mercyhealth Cancer Institute - Rockford
        • Principal Investigator:
          • Mayur Narkhede
        • Contact:
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Southern Illinois University School of Medicine
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 217-545-7929
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Springfield Clinic
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 800-444-7541
      • Springfield, Illinois, United States, 62781
        • Recruiting
        • Springfield Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • Carle Cancer Center
        • Contact:
        • Principal Investigator:
          • Maria T. Grosse-Perdekamp
    • Indiana
      • Michigan City, Indiana, United States, 46360
        • Recruiting
        • Woodland Cancer Care Center
        • Contact:
        • Principal Investigator:
          • William H. Bae
    • Iowa
      • Ankeny, Iowa, United States, 50023
        • Recruiting
        • UI Health Care Mission Cancer and Blood - Ankeny Clinic
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Richard L. Deming
      • Des Moines, Iowa, United States, 50309
        • Recruiting
        • UI Health Care Mission Cancer and Blood - Des Moines Clinic
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, United States, 50314
        • Recruiting
        • UI Health Care Mission Cancer and Blood - Laurel Clinic
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Seema Harichand-Herdt
      • Waukee, Iowa, United States, 50263
        • Recruiting
        • UI Health Care Mission Cancer and Blood - Waukee Clinic
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Seema Harichand-Herdt
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University of Kentucky/Markey Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 859-257-3379
        • Principal Investigator:
          • Susanne M. Arnold
      • Lexington, Kentucky, United States, 40509
    • Maine
      • Augusta, Maine, United States, 04330
        • Recruiting
        • Harold Alfond Center for Cancer Care
        • Contact:
          • Site Public Contact
          • Phone Number: 207-626-4855
        • Principal Investigator:
          • Leslie S. Bradford
      • Brewer, Maine, United States, 04412
        • Recruiting
        • Lafayette Family Cancer Center-EMMC
        • Principal Investigator:
          • Sarah J. Sinclair
        • Contact:
          • Site Public Contact
          • Phone Number: 800-987-3005
      • Scarborough, Maine, United States, 04074
        • Recruiting
        • MaineHealth Maine Medical Center- Scarborough
        • Principal Investigator:
          • Leslie S. Bradford
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland/Greenebaum Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-888-8823
        • Principal Investigator:
          • Ranee Mehra
      • Bethesda, Maryland, United States, 20892
        • Recruiting
        • National Institutes of Health Clinical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-411-1222
        • Principal Investigator:
          • Sarah Shin
      • Bethesda, Maryland, United States, 20889-5600
        • Recruiting
        • Walter Reed National Military Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 301-319-2100
        • Principal Investigator:
          • Christopher Tarney
      • Cumberland, Maryland, United States, 21502
        • Recruiting
        • UPMC Western Maryland
        • Contact:
          • Site Public Contact
          • Phone Number: 240-964-1400
        • Principal Investigator:
          • Sarah E. Taylor
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Recruiting
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Brighton, Michigan, United States, 48114
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Canton, Michigan, United States, 48188
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Chelsea, Michigan, United States, 48118
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Dearborn, Michigan, United States, 48124
        • Suspended
        • Corewell Health Dearborn Hospital
      • Escanaba, Michigan, United States, 49829
        • Recruiting
        • OSF Saint Francis Hospital and Medical Group
        • Principal Investigator:
          • Matthew L. Ryan
        • Contact:
      • Farmington Hills, Michigan, United States, 48336
        • Suspended
        • Corewell Health Farmington Hills Hospital
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Genesys Hurley Cancer Institute
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Hurley Medical Center
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Flint, Michigan, United States, 48503
        • Suspended
        • Genesee Hematology Oncology PC
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Cancer Hematology Centers - Flint
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Lansing, Michigan, United States, 48912
        • Recruiting
        • University of Michigan Health - Sparrow Lansing
        • Principal Investigator:
          • Tareq Al baghdadi
        • Contact:
      • Livonia, Michigan, United States, 48154
        • Recruiting
        • Trinity Health Saint Mary Mercy Livonia Hospital
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Pontiac, Michigan, United States, 48341
        • Recruiting
        • Trinity Health Saint Joseph Mercy Oakland Hospital
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Royal Oak, Michigan, United States, 48073
        • Suspended
        • Corewell Health William Beaumont University Hospital
      • Troy, Michigan, United States, 48085
        • Suspended
        • Corewell Health Beaumont Troy Hospital
      • Ypsilanti, Michigan, United States, 48197
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
    • Minnesota
      • Bemidji, Minnesota, United States, 56601
      • Deer River, Minnesota, United States, 56636
        • Recruiting
        • Essentia Health - Deer River Clinic
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Duluth, Minnesota, United States, 55805
        • Recruiting
        • Essentia Health Cancer Center
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Hibbing, Minnesota, United States, 55746
        • Recruiting
        • Essentia Health Hibbing Clinic
        • Principal Investigator:
          • Bret E. Friday
        • Contact:
          • Site Public Contact
          • Phone Number: 218-786-3308
      • Maplewood, Minnesota, United States, 55109
        • Recruiting
        • Saint John's Hospital - Healtheast
        • Contact:
        • Principal Investigator:
          • Yan Ji
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Contact:
          • Site Public Contact
          • Phone Number: 855-776-0015
        • Principal Investigator:
          • Grace M. Choong
      • Sandstone, Minnesota, United States, 55072
        • Recruiting
        • Essentia Health Sandstone
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Virginia, Minnesota, United States, 55792
        • Recruiting
        • Essentia Health Virginia Clinic
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
    • Missouri
      • Cape Girardeau, Missouri, United States, 63703
        • Recruiting
        • Saint Francis Medical Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 573-334-2230
          • Email: sfmc@sfmc.net
    • Montana
      • Anaconda, Montana, United States, 59711
        • Recruiting
        • Community Hospital of Anaconda
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Billings, Montana, United States, 59101
        • Recruiting
        • Billings Clinic Cancer Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Bozeman, Montana, United States, 59715
        • Recruiting
        • Bozeman Health Deaconess Hospital
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Great Falls, Montana, United States, 59405
        • Recruiting
        • Benefis Sletten Cancer Institute
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Kalispell, Montana, United States, 59901
        • Recruiting
        • Logan Health Medical Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Missoula, Montana, United States, 59804
        • Recruiting
        • Community Medical Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Recruiting
        • OptumCare Cancer Care at Charleston
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89183
        • Recruiting
        • OptumCare Cancer Care at Fort Apache
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
    • New Jersey
      • Jersey City, New Jersey, United States, 07302
        • Recruiting
        • Jersey City Medical Center
        • Contact:
        • Principal Investigator:
          • Eugenia Girda
      • Lakewood, New Jersey, United States, 08701
        • Recruiting
        • Monmouth Medical Center Southern Campus
        • Contact:
        • Principal Investigator:
          • Eugenia Girda
      • Long Branch, New Jersey, United States, 07740
        • Recruiting
        • Monmouth Medical Center
        • Contact:
        • Principal Investigator:
          • Eugenia Girda
      • New Brunswick, New Jersey, United States, 08903
        • Recruiting
        • Rutgers Cancer Institute of New Jersey
        • Contact:
          • Site Public Contact
          • Phone Number: 732-235-7356
        • Principal Investigator:
          • Eugenia Girda
      • Toms River, New Jersey, United States, 08755
        • Recruiting
        • Community Medical Center
        • Contact:
        • Principal Investigator:
          • Eugenia Girda
    • New York
      • Buffalo, New York, United States, 14263
        • Recruiting
        • Roswell Park Cancer Institute
        • Contact:
        • Principal Investigator:
          • Ellis G. Levine
      • Syracuse, New York, United States, 13210
        • Recruiting
        • State University of New York Upstate Medical University
        • Contact:
          • Site Public Contact
          • Phone Number: 315-464-5476
        • Principal Investigator:
          • Mary J. Cunningham
    • North Carolina
      • Asheboro, North Carolina, United States, 27205
        • Recruiting
        • Cone Health MedCenter Asheboro
        • Contact:
        • Principal Investigator:
          • Ni Gorsuch
      • Burlington, North Carolina, United States, 27215
        • Recruiting
        • Cone Health Cancer Center at Alamance Regional
        • Contact:
        • Principal Investigator:
          • Ni Gorsuch
      • Clinton, North Carolina, United States, 28328
        • Recruiting
        • Southeastern Medical Oncology Center-Clinton
        • Contact:
        • Principal Investigator:
          • Samer S. Kasbari
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
        • Principal Investigator:
          • Angeles A. Secord
        • Contact:
          • Site Public Contact
          • Phone Number: 888-275-3853
      • Goldsboro, North Carolina, United States, 27534
        • Recruiting
        • Southeastern Medical Oncology Center-Goldsboro
        • Contact:
        • Principal Investigator:
          • Samer S. Kasbari
      • Greensboro, North Carolina, United States, 27403
        • Recruiting
        • Cone Health Cancer Center
        • Contact:
        • Principal Investigator:
          • Ni Gorsuch
      • Greensboro, North Carolina, United States, 27410
        • Recruiting
        • Cone Health Cancer Center at Drawbridge Parkway
        • Contact:
        • Principal Investigator:
          • Ni Gorsuch
      • Jacksonville, North Carolina, United States, 28546
        • Recruiting
        • Southeastern Medical Oncology Center-Jacksonville
        • Principal Investigator:
          • Samer S. Kasbari
        • Contact:
      • Raleigh, North Carolina, United States, 27607
        • Recruiting
        • Duke Women's Cancer Care Raleigh
        • Principal Investigator:
          • Angeles A. Secord
        • Contact:
          • Site Public Contact
          • Phone Number: 919-785-4878
      • Reidsville, North Carolina, United States, 27320
        • Recruiting
        • Annie Penn Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Ni Gorsuch
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
      • Fargo, North Dakota, United States, 58122
      • Fargo, North Dakota, United States, 58122
    • Ohio
      • Athens, Ohio, United States, 45701
        • Recruiting
        • OhioHealth O'Bleness Hospital
        • Principal Investigator:
          • Aine E. Clements
        • Contact:
      • Centerville, Ohio, United States, 45459
        • Recruiting
        • Miami Valley Hospital South
        • Contact:
        • Principal Investigator:
          • Tarek M. Sabagh
      • Columbus, Ohio, United States, 43214
        • Recruiting
        • Columbus Oncology and Hematology Associates Inc
        • Principal Investigator:
          • Aine E. Clements
        • Contact:
      • Columbus, Ohio, United States, 43214
        • Recruiting
        • Riverside Methodist Hospital
        • Principal Investigator:
          • Aine E. Clements
        • Contact:
      • Columbus, Ohio, United States, 43215
        • Recruiting
        • Grant Medical Center
        • Principal Investigator:
          • Aine E. Clements
        • Contact:
      • Columbus, Ohio, United States, 43228
        • Recruiting
        • Doctors Hospital
        • Principal Investigator:
          • Aine E. Clements
        • Contact:
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Floor Backes
      • Dayton, Ohio, United States, 45409
        • Recruiting
        • Miami Valley Hospital
        • Contact:
        • Principal Investigator:
          • Tarek M. Sabagh
      • Dayton, Ohio, United States, 45415
        • Recruiting
        • Miami Valley Hospital North
        • Contact:
        • Principal Investigator:
          • Tarek M. Sabagh
      • Dayton, Ohio, United States, 45409
        • Recruiting
        • Premier Blood and Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 937-276-8320
        • Principal Investigator:
          • Tarek M. Sabagh
      • Dayton, Ohio, United States, 45415
        • Suspended
        • Dayton Physician LLC - Englewood
      • Delaware, Ohio, United States, 43015
        • Recruiting
        • Delaware Health Center-Grady Cancer Center
        • Principal Investigator:
          • Aine E. Clements
        • Contact:
      • Delaware, Ohio, United States, 43015
        • Recruiting
        • Grady Memorial Hospital
        • Principal Investigator:
          • Aine E. Clements
        • Contact:
      • Dublin, Ohio, United States, 43016
        • Recruiting
        • Columbus Oncology and Hematology Associates
        • Principal Investigator:
          • Aine E. Clements
        • Contact:
      • Dublin, Ohio, United States, 43016
        • Recruiting
        • Dublin Methodist Hospital
        • Principal Investigator:
          • Aine E. Clements
        • Contact:
      • Franklin, Ohio, United States, 45005-1066
        • Recruiting
        • Atrium Medical Center-Middletown Regional Hospital
        • Contact:
        • Principal Investigator:
          • Tarek M. Sabagh
      • Greenville, Ohio, United States, 45331
        • Recruiting
        • Miami Valley Cancer Care and Infusion
        • Principal Investigator:
          • Tarek M. Sabagh
        • Contact:
          • Site Public Contact
          • Phone Number: 937-569-7515
      • Kettering, Ohio, United States, 45429
        • Suspended
        • Kettering Medical Center
      • Mansfield, Ohio, United States, 44903
        • Recruiting
        • OhioHealth Mansfield Hospital
        • Principal Investigator:
          • Aine E. Clements
        • Contact:
      • Marion, Ohio, United States, 43302
        • Recruiting
        • OhioHealth Marion General Hospital
        • Principal Investigator:
          • Aine E. Clements
        • Contact:
      • Pickerington, Ohio, United States, 43147
        • Recruiting
        • OhioHealth Pickerington Methodist Hospital
        • Principal Investigator:
          • Aine E. Clements
        • Contact:
      • Troy, Ohio, United States, 45373
        • Recruiting
        • Upper Valley Medical Center
        • Contact:
        • Principal Investigator:
          • Tarek M. Sabagh
      • Westerville, Ohio, United States, 43082
        • Recruiting
        • OhioHealth Westerville Medical Campus/Westerville Cancer Center
        • Principal Investigator:
          • Aine E. Clements
        • Contact:
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Contact:
        • Principal Investigator:
          • Lauren E. Dockery
    • Oregon
      • Ontario, Oregon, United States, 97914
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Ontario
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center
        • Principal Investigator:
          • Dan S. Zuckerman
        • Contact:
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence Saint Vincent Medical Center
        • Principal Investigator:
          • Dan S. Zuckerman
        • Contact:
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16601
        • Recruiting
        • UPMC Altoona
        • Contact:
        • Principal Investigator:
          • Sarah E. Taylor
      • Erie, Pennsylvania, United States, 16505
        • Recruiting
        • UPMC Hillman Cancer Center Erie
        • Principal Investigator:
          • Sarah E. Taylor
        • Contact:
      • Greensburg, Pennsylvania, United States, 15601
        • Recruiting
        • UPMC Cancer Centers - Arnold Palmer Pavilion
        • Contact:
          • Site Public Contact
          • Phone Number: 724-838-1900
        • Principal Investigator:
          • Sarah E. Taylor
      • Mechanicsburg, Pennsylvania, United States, 17050
        • Recruiting
        • UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
        • Contact:
        • Principal Investigator:
          • Sarah E. Taylor
      • Monroeville, Pennsylvania, United States, 15146
        • Recruiting
        • UPMC Hillman Cancer Center - Monroeville
        • Principal Investigator:
          • Sarah E. Taylor
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University Hospital
        • Contact:
        • Principal Investigator:
          • Mitchell I. Edelson
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • University of Pittsburgh Cancer Institute (UPCI)
        • Contact:
          • Site Public Contact
          • Phone Number: 412-647-8073
        • Principal Investigator:
          • Sarah E. Taylor
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • UPMC-Magee Womens Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 412-647-2811
        • Principal Investigator:
          • Sarah E. Taylor
      • Pittsburgh, Pennsylvania, United States, 15237
        • Recruiting
        • UPMC-Passavant Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 412-367-6454
        • Principal Investigator:
          • Sarah E. Taylor
      • Willow Grove, Pennsylvania, United States, 19090
        • Recruiting
        • Asplundh Cancer Pavilion
        • Contact:
        • Principal Investigator:
          • Mitchell I. Edelson
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Recruiting
        • Women and Infants Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 401-274-1122
        • Principal Investigator:
          • Paul A. DiSilvestro
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
      • Sioux Falls, South Dakota, United States, 57117-5134
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Recruiting
        • Bristol Regional Medical Center
        • Principal Investigator:
          • Asheesh Shipstone
        • Contact:
      • Johnson City, Tennessee, United States, 37604
        • Recruiting
        • Regional Cancer Center at Johnson City Medical Center
        • Principal Investigator:
          • Asheesh Shipstone
        • Contact:
      • Kingsport, Tennessee, United States, 37660
        • Recruiting
        • Ballad Health Cancer Care - Kingsport
        • Principal Investigator:
          • Asheesh Shipstone
        • Contact:
      • Kingsport, Tennessee, United States, 37660
        • Recruiting
        • Wellmont Holston Valley Hospital and Medical Center
        • Principal Investigator:
          • Asheesh Shipstone
        • Contact:
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University/Ingram Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-811-8480
        • Principal Investigator:
          • Michael K. Gibson
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern/Simmons Cancer Center-Dallas
        • Contact:
        • Principal Investigator:
          • James L. Wilder
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Sarina A. Piha-Paul
      • Temple, Texas, United States, 76508
        • Recruiting
        • Scott and White Memorial Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 254-724-5407
        • Principal Investigator:
          • Lucas Wong
    • Virginia
      • Bristol, Virginia, United States, 24201
        • Recruiting
        • Ballad Health Cancer Care - Bristol
        • Principal Investigator:
          • Asheesh Shipstone
        • Contact:
      • Charlottesville, Virginia, United States, 22908
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Inova Schar Cancer Institute
        • Principal Investigator:
          • Timothy L. Cannon
        • Contact:
      • Falls Church, Virginia, United States, 22042
        • Recruiting
        • Inova Fairfax Hospital
        • Principal Investigator:
          • Timothy L. Cannon
        • Contact:
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • VCU Massey Comprehensive Cancer Center
        • Principal Investigator:
          • Chelsea Salyer
        • Contact:
      • Roanoke, Virginia, United States, 24033
        • Recruiting
        • Carilion Roanoke Memorial Hospital
        • Principal Investigator:
          • Chelsea Salyer
        • Contact:
          • Site Public Contact
          • Phone Number: 540-981-7377
    • Washington
      • Edmonds, Washington, United States, 98026
        • Recruiting
        • Swedish Cancer Institute-Edmonds
        • Principal Investigator:
          • Dan S. Zuckerman
        • Contact:
      • Issaquah, Washington, United States, 98029
        • Recruiting
        • Swedish Cancer Institute-Issaquah
        • Principal Investigator:
          • Dan S. Zuckerman
        • Contact:
      • Seattle, Washington, United States, 98122
        • Recruiting
        • Swedish Medical Center-First Hill
        • Principal Investigator:
          • Dan S. Zuckerman
        • Contact:
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • West Virginia University Healthcare
        • Contact:
        • Principal Investigator:
          • Mohammed Almubarak
    • Wisconsin
      • Ashland, Wisconsin, United States, 54806
        • Recruiting
        • Duluth Clinic Ashland
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Eau Claire, Wisconsin, United States, 54701
      • Green Bay, Wisconsin, United States, 54301
        • Recruiting
        • Saint Vincent Hospital Cancer Center Green Bay
        • Principal Investigator:
          • Matthew L. Ryan
        • Contact:
      • Green Bay, Wisconsin, United States, 54303
        • Recruiting
        • Saint Vincent Hospital Cancer Center at Saint Mary's
        • Principal Investigator:
          • Matthew L. Ryan
        • Contact:
      • La Crosse, Wisconsin, United States, 54601
        • Recruiting
        • Gundersen Lutheran Medical Center
        • Contact:
        • Principal Investigator:
          • Collin D. Driscoll
      • Marshfield, Wisconsin, United States, 54449
      • Minocqua, Wisconsin, United States, 54548
      • New Richmond, Wisconsin, United States, 54017
        • Recruiting
        • Cancer Center of Western Wisconsin
        • Contact:
        • Principal Investigator:
          • Yan Ji
      • Oconto Falls, Wisconsin, United States, 54154
        • Recruiting
        • Saint Vincent Hospital Cancer Center at Oconto Falls
        • Principal Investigator:
          • Matthew L. Ryan
        • Contact:
      • Rice Lake, Wisconsin, United States, 54868
      • Sheboygan, Wisconsin, United States, 53081
        • Recruiting
        • Saint Vincent Hospital Cancer Center at Sheboygan
        • Principal Investigator:
          • Matthew L. Ryan
        • Contact:
      • Stevens Point, Wisconsin, United States, 54482
      • Sturgeon Bay, Wisconsin, United States, 54235-1495
        • Recruiting
        • Saint Vincent Hospital Cancer Center at Sturgeon Bay
        • Principal Investigator:
          • Matthew L. Ryan
        • Contact:
      • Weston, Wisconsin, United States, 54476

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm I (neratinib maleate)
Patients receive neratinib maleate PO QD on days 1-14 of cycle 0 in the absence of disease progression or unacceptable toxicity. Patients then receive neratinib maleate PO QD on days 1-28 of each subsequent cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience progression may crossover to Arm II. Patients undergo ECHO or MUGA during screening and on study, and CT or MRI and collection of blood samples throughout the trial. Patients may also undergo tumor biopsy during screening and on study.
Procedure: Biospecimen Collection
Undergo collection of blood samples
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
  • Sample Collection
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Magnetic Resonance Imaging (MRI)
  • sMRI
  • Magnetic resonance imaging (procedure)
  • MRIs
  • Structural MRI
Procedure: Computed Tomography
Undergo CT scan
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography (CT) scan
  • Diagnostic CAT Scan
  • Diagnostic CAT Scan Service Type
Procedure: Multigated Acquisition Scan
Undergo MUGA
Other Names:
  • Blood Pool Scan
  • Equilibrium Radionuclide Angiography
  • Gated Blood Pool Imaging
  • MUGA
  • Radionuclide Ventriculography
  • RNVG
  • SYMA Scanning
  • Synchronized Multigated Acquisition Scanning
  • MUGA Scan
  • Multi-Gated Acquisition Scan
  • Radionuclide Ventriculogram Scan
  • Gated Heart Pool Scan
  • RNV Scan
Drug: Neratinib Maleate
Given PO
Other Names:
  • Nerlynx
  • 2-Butenamide, N-(4-((3-chloro-4-(2-pyridinylmethoxy)phenyl)amino)-3-cyano-7-ethoxy-6-quinolinyl)-4-(dimethylamino)-, (2E)-, (2Z)-2-butenedioate (1:1)
  • HKI-272 Maleate
  • NERATINIB MALEATE ANHYDROUS
Procedure: Echocardiography Test
Undergo ECHO
Other Names:
  • Echocardiography
  • EC
Procedure: Biopsy Procedure
Undergo tumor biopsy
Other Names:
  • Bx
  • BIOPSY_TYPE
  • Biopsy
Experimental: Arm II (neratinib maleate, palbociclib)
Patients receive neratinib maleate PO QD on days 1-14 of cycle 0 in the absence of disease progression or unacceptable toxicity. Patients then receive neratinib maleate PO QD on days 1-28 and palbociclib PO QD on days 1-21 of each subsequent cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening and on study, and CT or MRI and collection of blood samples throughout the trial. Patients may also undergo tumor biopsy during screening and on study.
Procedure: Biospecimen Collection
Undergo collection of blood samples
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
  • Sample Collection
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Magnetic Resonance Imaging (MRI)
  • sMRI
  • Magnetic resonance imaging (procedure)
  • MRIs
  • Structural MRI
Drug: Palbociclib
Given PO
Other Names:
  • Ibrance
  • 6-Acetyl-8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-8h-pyrido(2,3-d)pyrimidin-7-one
  • PD 0332991
  • PD 332991
  • PD 991
  • PD-0332991
  • PD0332991
Procedure: Computed Tomography
Undergo CT scan
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography (CT) scan
  • Diagnostic CAT Scan
  • Diagnostic CAT Scan Service Type
Procedure: Multigated Acquisition Scan
Undergo MUGA
Other Names:
  • Blood Pool Scan
  • Equilibrium Radionuclide Angiography
  • Gated Blood Pool Imaging
  • MUGA
  • Radionuclide Ventriculography
  • RNVG
  • SYMA Scanning
  • Synchronized Multigated Acquisition Scanning
  • MUGA Scan
  • Multi-Gated Acquisition Scan
  • Radionuclide Ventriculogram Scan
  • Gated Heart Pool Scan
  • RNV Scan
Drug: Neratinib Maleate
Given PO
Other Names:
  • Nerlynx
  • 2-Butenamide, N-(4-((3-chloro-4-(2-pyridinylmethoxy)phenyl)amino)-3-cyano-7-ethoxy-6-quinolinyl)-4-(dimethylamino)-, (2E)-, (2Z)-2-butenedioate (1:1)
  • HKI-272 Maleate
  • NERATINIB MALEATE ANHYDROUS
Procedure: Echocardiography Test
Undergo ECHO
Other Names:
  • Echocardiography
  • EC
Procedure: Biopsy Procedure
Undergo tumor biopsy
Other Names:
  • Bx
  • BIOPSY_TYPE
  • Biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: From study entry to time of progression or death, whichever occurs first, or date of last contact if neither progression nor death has occurred, assessed up to 2 years
The stratified log-rank statistic will be used to draw inferences about the relative activity of the two regimens. Characterized by medians and Kaplan-Meier (KM) curves.
From study entry to time of progression or death, whichever occurs first, or date of last contact if neither progression nor death has occurred, assessed up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: Up to 2 years
The impact of treatment on the hazard of death can be investigated with time dependent covariates.
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Haider S Mahdi, NRG Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2024

Primary Completion (Estimated)

February 20, 2027

Study Completion (Estimated)

February 20, 2027

Study Registration Dates

First Submitted

November 9, 2023

First Submitted That Met QC Criteria

November 9, 2023

First Posted (Actual)

November 13, 2023

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2023-09270 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • U10CA180868 (U.S. NIH Grant/Contract)
  • EAY191-N5 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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