Clinical Trials Browser

neratinib × Breast × Clear all

NCT01042379 2026-03-13

I-SPY

Phase 2 Recruiting

Pathologic Complete Response, Breast Neoplasms, Hemangiosarcoma, Neoplasms, Triple Negative Breast Neoplasms

NCT04886531 2026-03-12

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

Phase 2 Recruiting

Breast Neoplasms

NCT03101748 2026-02-12

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

Phase 1/2 Terminated

34 enrolled 15 charts

Breast Neoplasms, Inflammatory Breast Neoplasms

NCT01494662 2026-01-23

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

Phase 2 Completed

140 enrolled 32 charts

Breast Neoplasms

NCT03289039 2026-01-22

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

Phase 2 Terminated

21 enrolled 15 charts

Breast Neoplasms

NCT04965064 2025-12-15

Trial of Neratinib Plus Capecitabine in Subjects With HER2-Negative Metastatic Breast Cancer With Brain Metastases and Abnormally Active HER2 Signaling

Phase 2 Recruiting

Brain Neoplasms, Breast Neoplasms

NCT05760612 2025-09-25

Adjuvant Trastuzumab Plus Neratinib in Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer After Neoadjuvant Trastuzumab Plus Pertuzumab

Phase 3 Recruiting

Breast Neoplasms

NCT07152782 2025-09-03

THUNDER

Phase 2 Not yet recruiting

Breast Cancer With Brain Metastasis

NCT04388384 2025-08-06

ELEANOR

Breast Neoplasms

NCT03094052 2025-06-26

Incidence and Severity of Diarrhea in Patients With HER2 Positive Breast Cancer Treated With Trastuzumab and Neratinib

Phase 2 Completed

11 enrolled 12 charts

Breast Neoplasms

NCT07019272 2025-06-13

Neratinib in Extended Adjuvant Treatment for HER2+ Early Breast Cancer With pCR But High-Risk Features: A Hebei Multi-Center Real-World Study

Not yet recruiting

HER2-positive Breast Cancer

NCT05243641 2025-06-11

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

Phase 1/2 Terminated

10 enrolled 11 charts

Breast Neoplasms

NCT03377387 2025-04-15

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

Phase 1/2 Active not recruiting

Breast Neoplasms

NCT05252988 2025-04-01

DIANER

Phase 2 Active not recruiting

Breast Neoplasms

NCT06693024 2024-11-20

NeraHER2

HER2-positive Breast Cancer

NCT03878524 2024-03-04

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial

Phase 1 Terminated

BreastClassical hematologyGastrointestinalGenitourinaryLymphoidMyeloidOther hematologic neoplasmPlasma cell

Anemia, Blast Crisis, Breast Neoplasms, Hodgkin Disease, Lymphoma, Non-Hodgkin, Multiple Myeloma, Myelodysplastic Syndromes, Myeloproliferative Disorders, Neoplasm Metastasis, Pancreatic Neoplasms, Prostatic Neoplasms, Thrombocytosis, Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myeloid, Accelerated Phase, Leukemia, Myeloid, Chronic-Phase, Leukemia, Myeloid, Acute, Leukemia, Myelomonocytic, Chronic, Hematologic Neoplasms, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Myelodysplastic-Myeloproliferative Diseases, Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative, Primary Myelofibrosis

NCT04901299 2023-08-01

HER2-Signal

Phase 2 Withdrawn

Breast Neoplasms, Neoplasm Metastasis

NCT04366713 2023-02-10

A Study to Characterize Colon Pathology in Patients With HER2 Amplified Breast Cancer Treated With Neratinib

Phase 2 Completed

6 enrolled 8 charts

Breast Neoplasms

NCT02236000 2023-01-26

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

Phase 1/2 Completed

49 enrolled 17 charts

Breast Neoplasms

NCT04460430 2022-10-25

NEREA

Phase 2 Terminated

Breast Neoplasms

NCT05491057 2022-08-08

Treatment Patterns of Neratinib in HER2+ EBC in China

Not yet recruiting

Breast Neoplasms

NCT01670877 2022-04-15

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

Phase 2 Completed

56 enrolled 29 charts

Breast Neoplasms

NCT04856475 2022-03-02

NeraBrain

Phase 2 Withdrawn

Brain Neoplasms, Breast Neoplasms

NCT05154396 2021-12-13

Neratinib Dose Escalation Regimen for HER2 Positive Early Breast Cancer

Phase 2 Unknown

HER2-positive Breast Cancer

NCT01008150 2021-10-25

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

Phase 2 Completed

141 enrolled 16 charts

Breast Neoplasms

NCT00878709 2021-06-11

ExteNET

Phase 3 Completed

2,840 enrolled 25 charts 1 FDA

Breast Neoplasms

NCT01808573 2021-06-11

NALA

Phase 3 Completed

621 enrolled 21 charts 2 FDA

HER2+ Metastatic Breast Cancer (MBC)

NCT03182634 2019-01-22

plasmaMATCH

Phase 2 Unknown

Advanced Breast Cancer

NCT00146172 2018-09-17

Study Evaluating HKI-272 in Tumors

Phase 1 Completed

73 enrolled 20 charts

Breast Neoplasms, Neoplasms

NCT00741260 2018-09-05

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

Phase 1/2 Completed

105 enrolled 19 charts

Breast Neoplasms, Neoplasm Metastasis

NCT00915018 2018-08-22

NEFERTT

Phase 2 Completed

479 enrolled 13 charts

Breast Neoplasms

NCT00300781 2018-08-14

Study Evaluating HKI-272 (Neratinib) In Subjects With Advanced Breast Cancer

Phase 2 Completed

136 enrolled 11 charts

Breast Neoplasms, Neoplasms

NCT00706030 2018-08-09

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

Phase 1/2 Completed

92 enrolled 14 charts

Breast Neoplasms

NCT00777101 2018-08-09

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

Phase 2 Completed

233 enrolled 16 charts

Breast Neoplasms, Neoplasm Metastasis

NCT00445458 2018-07-26

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

Phase 1/2 Completed

110 enrolled 13 charts

Breast Neoplasms, Neoplasms

NCT00398567 2018-07-24

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

Phase 1/2 Completed

45 enrolled 15 charts

Breast Neoplasms

NCT00366600 2017-09-11

Study Evaluating HKI-272 Administered to Healthy Subjects

Phase 1 Completed

Breast Neoplasms

NCT01423123 2014-07-08

Combination of Weekly Paclitaxel With Neratinib and Trastuzumab in Women With Metastatic HER2-positive Breast Cancer

Phase 1 Completed

Breast Neoplasms

NCT00708903 2012-05-14

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

Phase 1 Completed

Breast Neoplasms