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ClinicalTrials.gov public records Last synced Sep 27, 2026, 9:43 PM EDT

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Showing 1–24 of 48 matching trials from the live ClinicalTrials.gov search.
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Filters: Sponsor: Puma Biotechnology, Inc. Clear all
Active, not recruiting Phase 1Phase 2 Interventional

Capecitabine 7/7 Schedule With Neratinib in Patients With Metastatic HER2-Positive Breast Cancer

NCT03377387
View directory record Official record
Conditions
Breast Cancer
Interventions
Capecitabine, Neratinib, EORTC QLQ - BR23, EQ-5D-5L, EORTC QLQ-C30
Drug · Behavioral
Lead sponsor
Memorial Sloan Kettering Cancer Center
Other
Eligibility
18 Years and older · Female only
Enrollment
34 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2026
U.S. locations
10
States / cities
Hartford, Connecticut • Miami, Florida • Basking Ridge, New Jersey + 7 more
Source: ClinicalTrials.gov public record
Updated Apr 15, 2026 · Synced Sep 27, 2026, 9:43 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Withdrawn Phase 2 Interventional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 10, 2023 · Synced Sep 27, 2026, 9:43 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 28, 2026 · Synced Sep 27, 2026, 9:43 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 11, 2026 · Synced Sep 27, 2026, 9:43 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 13, 2012 · Synced Sep 27, 2026, 9:43 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 30, 2022 · Synced Sep 27, 2026, 9:43 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 4, 2018 · Synced Sep 27, 2026, 9:43 PM EDT
Completed Phase 2 Interventional Results available

Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast Cancer

NCT00915018
View directory record Official record
Conditions
Breast Cancer
Interventions
Neratinib, Trastuzumab, Paclitaxel
Drug
Lead sponsor
Puma Biotechnology, Inc.
Industry
Eligibility
18 Years and older · Female only
Enrollment
479 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2018
U.S. locations
36
States / cities
Oxnard, California • Santa Rosa, California • Plainville, Connecticut + 32 more
Source: ClinicalTrials.gov public record
Updated Aug 21, 2018 · Synced Sep 27, 2026, 9:43 PM EDT
Completed Phase 1Phase 2 Interventional Results available

A Dose-Escalation Study Evaluating the Combination of Trastuzumab Emtansine (T-DM1) With Neratinib in Women With Metastatic HER2-Positive Breast Cancer

NCT02236000
View directory record Official record
Conditions
Breast Cancer
Interventions
Neratinib, T-DM1
Drug
Lead sponsor
NSABP Foundation Inc
Network
Eligibility
18 Years and older · Female only
Enrollment
49 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2021
U.S. locations
15
States / cities
Weston, Florida • Decatur, Illinois • Effingham, Illinois + 7 more
Source: ClinicalTrials.gov public record
Updated Jan 25, 2023 · Synced Sep 27, 2026, 9:43 PM EDT
Completed Phase 1Phase 2 Interventional Results available

A Phase 1/2 Study of HKI-272 (Neratinib) in Combination With Paclitaxel (Taxol) in Subjects With Solid Tumors and Breast Cancer

NCT00445458
View directory record Official record
Conditions
Advanced Breast Cancer, Advanced Malignant Solid Tumors, Breast Neoplasms
Interventions
HKI-272, Paclitaxel
Drug
Lead sponsor
Puma Biotechnology, Inc.
Industry
Eligibility
18 Years and older
Enrollment
110 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2018
U.S. locations
8
States / cities
La Jolla, California • San Diego, California • Boston, Massachusetts + 4 more
Source: ClinicalTrials.gov public record
Updated Jul 25, 2018 · Synced Sep 27, 2026, 9:43 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 2, 2026 · Synced Sep 27, 2026, 9:43 PM EDT
Completed Phase 1 Interventional Results available

Study Evaluating HKI-272 in Tumors

NCT00146172
View directory record Official record
Conditions
Breast Neoplasms
Interventions
neratinib
Drug
Lead sponsor
Puma Biotechnology, Inc.
Industry
Eligibility
18 Years and older
Enrollment
73 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2003 – 2007
U.S. locations
5
States / cities
Tampa, Florida • Boston, Massachusetts • St Louis, Missouri + 2 more
Source: ClinicalTrials.gov public record
Updated Sep 16, 2018 · Synced Sep 27, 2026, 9:43 PM EDT
Terminated Phase 2 Interventional Results available

Neratinib +/- Fulvestrant in HER2+, ER+ Metastatic Breast Cancer

NCT03289039
View directory record Official record
Conditions
Breast Cancer
Interventions
Neratinib, Fulvestrant
Drug
Lead sponsor
Dana-Farber Cancer Institute
Other
Eligibility
18 Years and older · Female only
Enrollment
21 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2021
U.S. locations
6
States / cities
Indianapolis, Indiana • Brewer, Maine • Boston, Massachusetts + 3 more
Source: ClinicalTrials.gov public record
Updated Jan 21, 2026 · Synced Sep 27, 2026, 9:43 PM EDT
Terminated Phase 2 Interventional Results available

Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations

NCT01953926
View directory record Official record
Conditions
Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations
Interventions
Neratinib, Fulvestrant, Trastuzumab, Paclitaxel
Drug
Lead sponsor
Puma Biotechnology, Inc.
Industry
Eligibility
18 Years and older
Enrollment
582 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2023
U.S. locations
30
States / cities
Birmingham, Alabama • Phoenix, Arizona • Duarte, California + 26 more
Source: ClinicalTrials.gov public record
Updated Mar 11, 2024 · Synced Sep 27, 2026, 9:43 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 17, 2018 · Synced Sep 27, 2026, 9:43 PM EDT
Recruiting Phase 2 Interventional

A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer

NCT06369285
View directory record Official record
Conditions
Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer, Recurrent Breast Cancer
Interventions
Alisertib, Endocrine therapy
Drug
Lead sponsor
Puma Biotechnology, Inc.
Industry
Eligibility
18 Years and older
Enrollment
225 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2029
U.S. locations
35
States / cities
Birmingham, Alabama • Phoenix, Arizona • Beverly Hills, California + 28 more
Source: ClinicalTrials.gov public record
Updated Jul 26, 2026 · Synced Sep 27, 2026, 9:43 PM EDT
Completed Phase 2 Interventional Results available

Neratinib With and Without Temsirolimus for Patients With HER2 Activating Mutations in Non-Small Cell Lung Cancer

NCT01827267
View directory record Official record
Conditions
HER2-mutant Non-Small Cell Lung Cancer
Interventions
neratinib, temsirolimus
Drug
Lead sponsor
Puma Biotechnology, Inc.
Industry
Eligibility
18 Years and older
Enrollment
62 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2017
U.S. locations
15
States / cities
Duarte, California • Santa Monica, California • Aurora, Colorado + 10 more
Source: ClinicalTrials.gov public record
Updated Jul 2, 2018 · Synced Sep 27, 2026, 9:43 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Study Evaluating The Potential Effect Of Rifampin On The Pharmacokinetics Of Neratinib

NCT00864487
View directory record Official record
Conditions
Healthy Subjects
Interventions
Neratinib
Drug
Lead sponsor
Puma Biotechnology, Inc.
Industry
Eligibility
18 Years to 50 Years
Enrollment
24 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2009
U.S. locations
1
States / cities
Miami, Florida
Source: ClinicalTrials.gov public record
Updated May 13, 2012 · Synced Sep 27, 2026, 9:43 PM EDT
Completed Phase 1Phase 2 Interventional Results available

Temsirolimus Plus Neratinib for Patients With Metastatic HER2-Amplified or Triple Negative Breast Cancer

NCT01111825
View directory record Official record
Conditions
Breast Cancer
Interventions
Temsirolimus, Neratinib
Drug
Lead sponsor
Puma Biotechnology, Inc.
Industry
Eligibility
18 Years and older
Enrollment
99 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2016
U.S. locations
4
States / cities
Goodyear, Arizona • Los Angeles, California • New York, New York
Source: ClinicalTrials.gov public record
Updated Sep 25, 2018 · Synced Sep 27, 2026, 9:43 PM EDT
Completed Phase 1Phase 2 Interventional Results available

Study Evaluating Neratinib (HKI-272) In Combination With Vinorelbine In Subjects With Solid Tumors And Metastatic Breast Cancer

NCT00706030
View directory record Official record
Conditions
Breast Cancer, Advanced Malignant Solid Tumors
Interventions
neratinib, vinorelbine
Drug
Lead sponsor
Puma Biotechnology, Inc.
Industry
Eligibility
18 Years and older
Enrollment
92 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2018
U.S. locations
8
States / cities
Fayetteville, Arkansas • Duarte, California • Lebanon, New Hampshire + 5 more
Source: ClinicalTrials.gov public record
Updated Aug 8, 2018 · Synced Sep 27, 2026, 9:43 PM EDT
Completed Phase 2 Interventional Results available

Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer

NCT00777101
View directory record Official record
Conditions
Advanced Breast Cancer, Breast Cancer
Interventions
Neratinib, Lapatinib, Capecitabine
Drug
Lead sponsor
Puma Biotechnology, Inc.
Industry
Eligibility
18 Years and older · Female only
Enrollment
233 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2018
U.S. locations
44
States / cities
Tucson, Arizona • Murrieta, California • Orange, California + 40 more
Source: ClinicalTrials.gov public record
Updated Aug 8, 2018 · Synced Sep 27, 2026, 9:43 PM EDT
Completed Phase 2 Interventional Results available

An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide

NCT02400476
View directory record Official record
Conditions
Early Stage HER2+ Breast Cancer
Interventions
Neratinib, Loperamide, Colestipol, Budesonide
Drug
Lead sponsor
Puma Biotechnology, Inc.
Industry
Eligibility
18 Years and older
Enrollment
563 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2021
U.S. locations
39
States / cities
Birmingham, Alabama • Corona, California • Fullerton, California + 36 more
Source: ClinicalTrials.gov public record
Updated May 5, 2022 · Synced Sep 27, 2026, 9:43 PM EDT
Recruiting Phase 2 Interventional

Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers

NCT05919108
View directory record Official record
Conditions
Anatomic Stage I Breast Cancer, Anatomic Stage II Breast Cancer, Anatomic Stage III Breast Cancer, Invasive Breast Lobular Carcinoma
Interventions
Endocrine Therapy, Biopsy of breast, Neratinib, Biospecimen Collection, Mammogram, Magnetic Resonance Imaging, Breast Surgery, Ultrasound
Procedure · Drug
Lead sponsor
Vanderbilt-Ingram Cancer Center
Other
Eligibility
18 Years and older
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2031
U.S. locations
5
States / cities
Atlanta, Georgia • Pittsburgh, Pennsylvania • Nashville, Tennessee + 2 more
Source: ClinicalTrials.gov public record
Updated Aug 18, 2026 · Synced Sep 27, 2026, 9:43 PM EDT
Completed Phase 2 Interventional Results available

Neratinib +/- Fulvestrant in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer

NCT01670877
View directory record Official record
Conditions
Breast Neoplasms
Interventions
Neratinib, Fulvestrant, Trastuzumab, Tumor biopsy, Research blood sample
Drug · Procedure
Lead sponsor
Washington University School of Medicine
Other
Eligibility
18 Years and older
Enrollment
56 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2021
U.S. locations
15
States / cities
Birmingham, Alabama • Phoenix, Arizona • Los Angeles, California + 11 more
Source: ClinicalTrials.gov public record
Updated Apr 14, 2022 · Synced Sep 27, 2026, 9:43 PM EDT