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ClinicalTrials.gov public records Last synced Oct 3, 2026, 10:57 AM EDT

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Showing 25–48 of 48 matching trials from the live ClinicalTrials.gov search.
Filters: Sponsor: Puma Biotechnology, Inc. Clear all
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 3, 2026, 10:57 AM 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 3, 2026, 10:57 AM 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Withdrawn Phase 2 Interventional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 3, 2026, 10:57 AM EDT
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 3, 2026, 10:57 AM 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 22, 2026 · Synced Oct 3, 2026, 10:57 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Study Evaluating The Tolerability Of Multiple Doses Of HKI-272

NCT00757809
View directory record Official record
Conditions
Healthy Subjects
Interventions
neratinib
Drug
Lead sponsor
Puma Biotechnology, Inc.
Industry
Eligibility
18 Years to 50 Years
Enrollment
50 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2008
U.S. locations
2
States / cities
Austin, Texas • Tacoma, Washington
Source: ClinicalTrials.gov public record
Updated May 14, 2012 · Synced Oct 3, 2026, 10:57 AM 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 3, 2026, 10:57 AM EDT
Completed Phase 3 Interventional Results available

A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting

NCT01808573
View directory record Official record
Conditions
HER2+ Metastatic Breast Cancer (MBC)
Interventions
neratinib, capecitabine, lapatinib
Drug
Lead sponsor
Puma Biotechnology, Inc.
Industry
Eligibility
18 Years and older
Enrollment
621 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2019
U.S. locations
79
States / cities
Chandler, Arizona • Gilbert, Arizona • Mesa, Arizona + 56 more
Source: ClinicalTrials.gov public record
Updated Jun 11, 2021 · Synced Oct 3, 2026, 10:57 AM 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 9, 2018 · Synced Oct 3, 2026, 10:57 AM 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 3, 2026, 10:57 AM 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 3, 2026, 10:57 AM 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 26, 2018 · Synced Oct 3, 2026, 10:57 AM 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 3, 2026, 10:57 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Study Evaluating The Potential Effect Of Multiple Doses Of Neratinib On The Pharmacokinetics Of A Single Dose Of Digoxin

NCT00860223
View directory record Official record
Conditions
Healthy
Interventions
Digoxin, Neratinib
Drug
Lead sponsor
Puma Biotechnology, Inc.
Industry
Eligibility
18 Years to 50 Years
Enrollment
27 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2009
U.S. locations
1
States / cities
Miami, Florida
Source: ClinicalTrials.gov public record
Updated May 14, 2012 · Synced Oct 3, 2026, 10:57 AM 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 3, 2026, 10:57 AM 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 3, 2026, 10:57 AM 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 3, 2026, 10:57 AM 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 Oct 1, 2026 · Synced Oct 3, 2026, 10:57 AM 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 14, 2012 · Synced Oct 3, 2026, 10:57 AM EDT
Completed Phase 1 Interventional

Alisertib in Combination With Osimertinib in Metastatic EGFR-mutant Lung Cancer

NCT04085315
View directory record Official record
Conditions
Lung Cancer Metastatic, EGFR Gene Mutation
Interventions
Osimertinib, Alisertib
Drug
Lead sponsor
Collin Blakely
Other
Eligibility
18 Years and older
Enrollment
23 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2025
U.S. locations
1
States / cities
San Francisco, California
Source: ClinicalTrials.gov public record
Updated Aug 11, 2026 · Synced Oct 3, 2026, 10:57 AM 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 15, 2022 · Synced Oct 3, 2026, 10:57 AM EDT
Completed Phase 1Phase 2 Interventional Results available

A Phase 1/2 Study Of HKI-272 (Neratinib) in Combination With Trastuzumab (Herceptin) In Subjects With Advanced Breast Cancer

NCT00398567
View directory record Official record
Conditions
Advanced Breast Cancer
Interventions
HKI-272, trastuzumab
Drug
Lead sponsor
Puma Biotechnology, Inc.
Industry
Eligibility
18 Years and older
Enrollment
45 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2018
U.S. locations
6
States / cities
Duarte, California • Los Angeles, California • Pasadena, California + 3 more
Source: ClinicalTrials.gov public record
Updated Jul 24, 2018 · Synced Oct 3, 2026, 10:57 AM 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 3, 2026, 10:57 AM EDT
Recruiting Phase 1 Interventional

Neratinib and Fam-Trastuzumab Deruxtecan in Advanced Gastro-esophageal Cancer Patients

NCT05274048
View directory record Official record
Conditions
Gastric Cancer, Gastrointestinal Cancer, HER2 Gene Mutation
Interventions
Neratinib Pill, Fam-Trastuzumab Deruxtecan-Nxki (TDxD)
Drug
Lead sponsor
Fox Chase Cancer Center
Other
Eligibility
18 Years and older
Enrollment
18 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2028
U.S. locations
3
States / cities
Palo Alto, California • Buffalo, New York • Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Sep 21, 2026 · Synced Oct 3, 2026, 10:57 AM EDT