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ClinicalTrials.gov public records Last synced Oct 17, 2026, 10:12 PM EDT

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Showing 1–24 of 64 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Neratinib Clear all
Completed Phase 1 Interventional Accepts healthy volunteers

Open-label PK Study to Evaluate Lansoprazole and Neratinib in Healthy Subjects

NCT02334501
View directory record Official record
Conditions
Healthy
Interventions
Lansoprazole, Neratinib
Drug
Lead sponsor
Puma Biotechnology, Inc.
Industry
Eligibility
18 Years to 55 Years
Enrollment
15 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2014
U.S. locations
1
States / cities
Tempe, Arizona
Source: ClinicalTrials.gov public record
Updated May 11, 2016 · Synced Oct 17, 2026, 10:12 PM EDT
Terminated Phase 1Phase 2 Interventional Results available

Neratinib and Capmatinib Combination (Phase Ib/II) in Metastatic Breast Cancer and Inflammatory Breast Cancer Patients With Abnormal HER-family and c-Met Pathway Activity as Measured by the CELsignia Signaling Analysis Test

NCT05243641
View directory record Official record
Conditions
Metastatic Breast Cancer, Breast Cancer
Interventions
Neratinib, Capmatinib
Drug
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years and older
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2024
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Jun 11, 2025 · Synced Oct 17, 2026, 10:12 PM EDT
Terminated Phase 1 Interventional

Phase1 of Neratinib+Trastuzumab, Pertuzumab, Paclitaxel in Patients With Advanced Solid Tumors/HER2+

NCT02593708
View directory record Official record
Conditions
Solid Tumor
Interventions
Neratinib, Paclitaxel, Pertuzumab, Trastuzumab
Drug
Lead sponsor
Michelle Melisko
Other
Eligibility
18 Years and older
Enrollment
6 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2017
U.S. locations
1
States / cities
San Francisco, California
Source: ClinicalTrials.gov public record
Updated Nov 17, 2017 · Synced Oct 17, 2026, 10:12 PM EDT
Withdrawn Phase 2 Interventional

Fulvestrant + Neratinib In Breast Cancer

NCT04901299
View directory record Official record
Conditions
Stage IV (Metastatic) Breast Cancer, Metastatic Breast Cancer, ER Positive Breast Cancer, PR-Positive Breast Cancer, HER2-negative Breast Cancer, Invasive Breast Cancer
Interventions
NERATINIB, FULVESTRANT
Drug
Lead sponsor
Massachusetts General Hospital
Other
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2025
U.S. locations
2
States / cities
Boston, Massachusetts • Nashville, Tennessee
Source: ClinicalTrials.gov public record
Updated Aug 1, 2023 · Synced Oct 17, 2026, 10:12 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Study to Examine the Effect of HKI-272 on Rhythms of the Heart (Cardiac Repolarization)

NCT00708903
View directory record Official record
Conditions
Breast Cancer
Interventions
neratinib, Placebo, Moxifloxacin
Drug · Other
Lead sponsor
Puma Biotechnology, Inc.
Industry
Eligibility
18 Years to 50 Years
Enrollment
60 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2008
U.S. locations
1
States / cities
Tacoma, Washington
Source: ClinicalTrials.gov public record
Updated May 14, 2012 · Synced Oct 17, 2026, 10:12 PM EDT
Completed Phase 1 Interventional Results available

Study Evaluating Neratinib In Combination With Temsirolimus In Subjects With Solid Tumors

NCT00838539
View directory record Official record
Conditions
Neoplasms, Malignant Carcinoma
Interventions
Neratinib, Temsirolimus
Drug
Lead sponsor
Puma Biotechnology, Inc.
Industry
Eligibility
18 Years and older
Enrollment
63 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2013
U.S. locations
4
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Sep 18, 2018 · Synced Oct 17, 2026, 10:12 PM EDT
Not listed Phase 2 Interventional

Evaluating the Efficacy of Neratinib on Live Cell HER2 Signaling Transduction Analysis Positive Triple Negative Breast

NCT03812393
View directory record Official record
Conditions
Triple Negative Breast Cancer, Early-stage Breast Cancer, HER2-positive Breast Cancer
Interventions
Neratinib
Drug
Lead sponsor
West Cancer Center
Other
Eligibility
18 Years and older
Enrollment
27 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2024
U.S. locations
1
States / cities
Germantown, Tennessee
Source: ClinicalTrials.gov public record
Updated Dec 18, 2023 · Synced Oct 17, 2026, 10:12 PM EDT
Recruiting Phase 2 Interventional

Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor

NCT05933395
View directory record Official record
Conditions
Advanced Breast Cancer
Interventions
Fulvestrant, Neratinib, Alpelisib, Everolimus, Abemaciclib
Drug
Lead sponsor
Dartmouth-Hitchcock Medical Center
Other
Eligibility
18 Years and older · Female only
Enrollment
135 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2031
U.S. locations
1
States / cities
Lebanon, New Hampshire
Source: ClinicalTrials.gov public record
Updated Jan 20, 2026 · Synced Oct 17, 2026, 10:12 PM EDT
Completed Phase 2 Interventional Results available

HKI-272 for HER2-Positive Breast Cancer and Brain Metastases

NCT01494662
View directory record Official record
Conditions
Breast Cancer
Interventions
HKI-272, Surgical Resection, Capecitabine, Ado-Trastuzumab Emtansine
Drug · Procedure
Lead sponsor
Dana-Farber Cancer Institute
Other
Eligibility
18 Years and older
Enrollment
140 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2024
U.S. locations
18
States / cities
San Francisco, California • Washington D.C., District of Columbia • Baltimore, Maryland + 11 more
Source: ClinicalTrials.gov public record
Updated Jan 23, 2026 · Synced Oct 17, 2026, 10:12 PM EDT
Withdrawn Phase 2 Interventional

Neratinib in Patients With Metastatic Castration-Resistant Prostate Cancer

NCT04781374
View directory record Official record
Conditions
Metastatic Prostate Adenocarcinoma, Castration-resistant Prostate Cancer, Prostate Cancer, Prostate Cancer Metastatic
Interventions
Neratinib
Drug
Lead sponsor
Beth Israel Deaconess Medical Center
Other
Eligibility
18 Years and older · Male only
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021
U.S. locations
3
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Jul 11, 2023 · Synced Oct 17, 2026, 10:12 PM EDT
Completed No phase listed Observational Accepts healthy volunteers

A Single Dose Bioequivalence Study Of Neratinib In Healthy Subjects

NCT01142063
View directory record Official record
Conditions
Healthy
Interventions
Neratinib
Drug
Lead sponsor
Puma Biotechnology, Inc.
Industry
Eligibility
18 Years to 55 Years
Enrollment
28 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2010
U.S. locations
1
States / cities
New Haven, Connecticut
Source: ClinicalTrials.gov public record
Updated May 14, 2012 · Synced Oct 17, 2026, 10:12 PM EDT
Completed Phase 2 Interventional Results available

Phase II Randomized Trial Evaluating Neoadjuvant Therapy With Neratinib and/or Trastuzumab Followed by Postoperative Trastuzumab in Women With Locally Advanced HER2-positive Breast Cancer

NCT01008150
View directory record Official record
Conditions
Breast Cancer
Interventions
Paclitaxel, Trastuzumab, Neratinib, Doxorubicin, Cyclophosphamide
Drug
Lead sponsor
NSABP Foundation Inc
Network
Eligibility
18 Years and older · Female only
Enrollment
141 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2016
U.S. locations
30
States / cities
Loma Linda, California • San Diego, California • Denver, Colorado + 25 more
Source: ClinicalTrials.gov public record
Updated Oct 25, 2021 · Synced Oct 17, 2026, 10:12 PM EDT
Not listed Phase 2 Interventional

Study of Neratinib +Trastuzumab or Neratinib + Cetuximab in Patients With KRAS/NRAS/BRAF/PIK3CA Wild-Type Metastatic Colorectal Cancer by HER2 Status

NCT03457896
View directory record Official record
Conditions
Metastatic Colorectal Cancer
Interventions
Trastuzumab, Cetuximab, Neratinib, Guardant360 Diagnostic Test
Drug · Diagnostic Test
Lead sponsor
NSABP Foundation Inc
Network
Eligibility
18 Years and older
Enrollment
35 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2022
U.S. locations
48
States / cities
Anaheim, California • Baldwin Park, California • Bellflower, California + 40 more
Source: ClinicalTrials.gov public record
Updated Mar 31, 2022 · Synced Oct 17, 2026, 10:12 PM EDT
Terminated Phase 1 Interventional

Neratinib and Everolimus, Palbociclib, or Trametinib in Treating Participants With Refractory and Advanced or Metastatic Solid Tumors With EGFR Mutation/Amplification, HER2 Mutation/Amplification, or HER3/4 Mutation or KRAS Mutation

NCT03065387
View directory record Official record
Conditions
Advanced Malignant Solid Neoplasm, EGFR Gene Amplification, EGFR Gene Mutation, ERBB2 Gene Amplification, ERBB2 Gene Mutation, ERBB3 Gene Mutation, ERBB4 Gene Mutation, KRAS Gene Mutation, Metastatic Malignant Solid Neoplasm, Refractory Malignant Solid Neoplasm
Interventions
Everolimus, Neratinib, Palbociclib, Trametinib
Drug
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years and older
Enrollment
84 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2026
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Jul 22, 2026 · Synced Oct 17, 2026, 10:12 PM EDT
Withdrawn Phase 1Phase 2 Interventional

Safety and Efficacy Study of Neratinib and Cetuximab to Treat Patients With Quadruple Wild-Type Metastatic Colorectal Cancer

NCT01960023
View directory record Official record
Conditions
Colorectal Cancer
Interventions
Cetuximab, Neratinib
Drug
Lead sponsor
NSABP Foundation Inc
Network
Eligibility
18 Years and older
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2016
U.S. locations
12
States / cities
Gainesville, Florida • Orlando, Florida • Boise, Idaho + 7 more
Source: ClinicalTrials.gov public record
Updated Oct 27, 2021 · Synced Oct 17, 2026, 10:12 PM EDT
Active, not recruiting Phase 2 Interventional

Neratinib In Combination With Chemotherapy/Trastuzumab/Pembrolizumab In HER2 Gastroesophageal Cancer

NCT06109467
View directory record Official record
Conditions
GastroEsophageal Cancer, Gastric Cancer
Interventions
Neratinib, Trastuzumab, Oxaliplatin, 5-Fluorouracil + leucovorin, Pembrolizumab
Drug
Lead sponsor
H. Lee Moffitt Cancer Center and Research Institute
Other
Eligibility
18 Years and older
Enrollment
8 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2028
U.S. locations
1
States / cities
Tampa, Florida
Source: ClinicalTrials.gov public record
Updated Jun 12, 2026 · Synced Oct 17, 2026, 10:12 PM EDT
Recruiting Phase 2 Interventional

Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers

NCT04886531
View directory record Official record
Conditions
Breast Cancer, HER2-positive Breast Cancer, ER Positive Breast Cancer, PR-Positive Breast Cancer
Interventions
Neratinib, Letrozole (L) or Anastrozole (A), Trastuzumab
Drug
Lead sponsor
Ruth O'Regan
Other
Eligibility
18 Years and older
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2027
U.S. locations
4
States / cities
Chicago, Illinois • Rochester, New York • Hershey, Pennsylvania + 1 more
Source: ClinicalTrials.gov public record
Updated Sep 3, 2026 · Synced Oct 17, 2026, 10:12 PM EDT
Completed Phase 1Phase 2 Interventional Results available

Study Evaluating The Combination Of Neratinib And Capecitabine In Solid Tumors And Breast Cancer

NCT00741260
View directory record Official record
Conditions
Breast Cancer
Interventions
Neratinib, Capecitabine
Drug
Lead sponsor
Puma Biotechnology, Inc.
Industry
Eligibility
18 Years and older
Enrollment
105 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2018
U.S. locations
12
States / cities
Mobile, Alabama • Long Beach, California • Los Angeles, California + 9 more
Source: ClinicalTrials.gov public record
Updated Sep 5, 2018 · Synced Oct 17, 2026, 10:12 PM EDT
Suspended Phase 1Phase 2 Interventional

Neratinib + Valproate in Advanced Solid Tumors, w/Expansion Cohort in Ras-Mutated Ca

NCT03919292
View directory record Official record
Conditions
Solid Tumor, Adult
Interventions
Neratinib, Divalproex Sodium
Drug
Lead sponsor
Virginia Commonwealth University
Other
Eligibility
18 Years and older
Enrollment
83 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2031
U.S. locations
1
States / cities
Richmond, Virginia
Source: ClinicalTrials.gov public record
Updated Jun 29, 2026 · Synced Oct 17, 2026, 10:12 PM EDT
Recruiting Early Phase 1 Interventional

Pilot Study of [68Ga]Ga-ABY-025 Imaging in Patients Undergoing Treatment With HER2-targeted Therapy

NCT06828588
View directory record Official record
Conditions
Locally Advanced Cancer, Metastatic Cancer, HER2, HER2 + Breast Cancer, HER2 + Gastric Cancer, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma, HER 2 Low-expressing Breast Cancer
Interventions
[68Ga]Ga-ABY-025
Drug
Lead sponsor
Vanderbilt-Ingram Cancer Center
Other
Eligibility
18 Years and older
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2029
U.S. locations
1
States / cities
Nashville, Tennessee
Source: ClinicalTrials.gov public record
Updated May 8, 2026 · Synced Oct 17, 2026, 10:12 PM EDT
Completed Phase 2 Interventional Results available

Neratinib in Treating Older Patients With Stage IV HER2-Positive Breast Cancer

NCT02673398
View directory record Official record
Conditions
HER2 Positive Breast Carcinoma, Stage IV Breast Cancer AJCC v6 and v7
Interventions
Comprehensive Geriatric Assessment, Laboratory Biomarker Analysis, Neratinib, Pharmacological Study
Other · Drug
Lead sponsor
City of Hope Medical Center
Other
Eligibility
60 Years and older
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2022
U.S. locations
7
States / cities
Corona, California • Duarte, California • Lancaster, California + 4 more
Source: ClinicalTrials.gov public record
Updated Jun 18, 2023 · Synced Oct 17, 2026, 10:12 PM EDT
Terminated Phase 1Phase 2 Interventional Results available

Neratinib and Paclitaxel With or Without Pertuzumab and Trastuzumab Before Combination Chemotherapy in Treating Patients With Metastatic or Locally Advanced Breast Cancer

NCT03101748
View directory record Official record
Conditions
Breast Inflammatory Carcinoma, Locally Advanced Breast Carcinoma, Metastatic Breast Carcinoma, Stage III Breast Cancer AJCC v7, Stage IIIA Breast Cancer AJCC v7, Stage IIIB Breast Cancer AJCC v7, Stage IIIC Breast Cancer AJCC v7, Stage IV Breast Cancer AJCC v6 and v7
Interventions
Cyclophosphamide, Doxorubicin, Laboratory Biomarker Analysis, Neratinib, Paclitaxel, Pertuzumab, Trastuzumab
Drug · Other · Biological
Lead sponsor
M.D. Anderson Cancer Center
Other
Eligibility
18 Years and older
Enrollment
34 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2025
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Feb 12, 2026 · Synced Oct 17, 2026, 10:12 PM EDT
Terminated No phase listed Observational

HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib

NCT03786107
View directory record Official record
Conditions
Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer, Metastatic Cervical Cancer
Interventions
Almac HER-Seq Assay
Diagnostic Test
Lead sponsor
Puma Biotechnology, Inc.
Industry
Eligibility
18 Years and older
Enrollment
1,583 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2021
U.S. locations
1
States / cities
Pittsburgh, Pennsylvania
Source: ClinicalTrials.gov public record
Updated May 19, 2021 · Synced Oct 17, 2026, 10:12 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Study Comparing 2 New Formulations of HKI-272 in Healthy Adult Subjects

NCT00498745
View directory record Official record
Conditions
Healthy
Interventions
neratinib
Drug
Lead sponsor
Puma Biotechnology, Inc.
Industry
Eligibility
18 Years to 50 Years
Enrollment
36 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2007
U.S. locations
1
States / cities
San Antonio, Texas
Source: ClinicalTrials.gov public record
Updated May 14, 2012 · Synced Oct 17, 2026, 10:12 PM EDT