Neratinib

Generic Name: Neratinib

Brand Names: Nerlynx

Drug Type: Small Molecule

Chemical Formula: C_₃₀H_₂₉ClN_₆O_₃

CAS Number: 698387-09-6

Unique Ingredient Identifier: JJH94R3PWB

Background: Neratinib was approved in July 2017 for use as an extended adjuvant therapy in Human Epidermal Growth Factor Receptor 2 (HER2) positive breast cancer. Approval was granted to Puma Biotechnology Inc. for the tradename Nerlynx. Neratinib is currently under investigation for use in many other forms of cancer.

Indication: For use as an extended adjuvant treatment in adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy [FDA Label].

Associated Conditions: Breast Cancer

Clinical Trials

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

Phase 2

Recruiting

Conditions: Anatomic Stage I Breast Cancer
Anatomic Stage II Breast Cancer
Anatomic Stage III Breast Cancer
Invasive Breast Lobular Carcinoma

Interventions: Procedure: Endocrine Therapy
Procedure: Biopsy of breast
Drug: Neratinib
Procedure: Biospecimen Collection
Procedure: Mammogram
Procedure: Magnetic Resonance Imaging
Procedure: Breast Surgery
Procedure: Ultrasound

First Posted Date: 2023-06-26

Last Posted Date: 2024-11-20

Lead Sponsor: Vanderbilt-Ingram Cancer Center

Target Recruit Count: 30

Registration Number: NCT05919108

Locations: 🇺🇸
Baylor College of Medicine, Houston, Texas, United States
🇺🇸
Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States
🇺🇸
Emory University/ Winship Cancer Institute, Atlanta, Georgia, United States

and more 2 locations

Personalized Medicine for Advanced Biliary Cancer Patients

Phase 3

Recruiting

Conditions: Biliary Tract Neoplasms

Interventions: Drug: Futibatinib
Drug: Cisplatin
Drug: Ivosidenib
Drug: Gemcitabine
Drug: Zanidatamab
Drug: Trastuzumab
Drug: Neratinib
Drug: Encorafenib
Drug: Binimetinib
Drug: Niraparib

First Posted Date: 2022-11-14

Last Posted Date: 2025-04-23

Lead Sponsor: UNICANCER

Target Recruit Count: 800

Registration Number: NCT05615818

Locations: 🇫🇷
APHP - Hôpital Paul Brousse, Villejuif, France
🇫🇷
Gustave Roussy, Villejuif, France
🇫🇷
APHP - Hôpital Cochin, Paris, France

and more 66 locations

Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial

Phase 2

Recruiting

Conditions: Advanced Malignant Solid Neoplasm
Anatomic Stage III Breast Cancer AJCC v8
Anatomic Stage IV Breast Cancer AJCC v8
Locally Advanced Malignant Solid Neoplasm
Malignant Female Reproductive System Neoplasm
Metastatic HER2-Negative Breast Carcinoma
Metastatic Malignant Solid Neoplasm
Recurrent Endometrial Carcinoma
Recurrent Fallopian Tube Carcinoma
Recurrent Malignant Female Reproductive System Neoplasm

Interventions: Drug: Alpelisib
Drug: Binimetinib
Procedure: Biopsy Procedure
Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspiration
Procedure: Bone Scan
Drug: Ipatasertib
Procedure: Computed Tomography
Procedure: Echocardiography Test
Drug: Nilotinib Hydrochloride Monohydrate
Biological: Panitumumab
Procedure: Magnetic Resonance Imaging
Drug: Palbociclib
Drug: Fluorouracil
Drug: Paclitaxel
Drug: Sotorasib
Drug: Olaparib
Drug: Leucovorin
Drug: Fulvestrant
Procedure: Mutation Carrier Screening
Drug: Neratinib Maleate
Procedure: Positron Emission Tomography
Procedure: Multigated Acquisition Scan
Drug: Selumetinib Sulfate
Drug: Oxaliplatin

First Posted Date: 2022-10-03

Last Posted Date: 2025-05-21

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 2900

Registration Number: NCT05564377

Locations: 🇺🇸
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
🇺🇸
University of South Alabama Mitchell Cancer Institute, Mobile, Alabama, United States
🇺🇸
Alaska Women's Cancer Care, Anchorage, Alaska, United States

and more 443 locations

Treatment Patterns of Neratinib in HER2+ EBC in China

Not yet recruiting

Conditions: Breast Cancer

Interventions: Drug: Neratinib

First Posted Date: 2022-08-08

Last Posted Date: 2022-08-08

Lead Sponsor: Pierre Fabre Medicament

Target Recruit Count: 500

Registration Number: NCT05491057

Locations: 🇨🇳
Medical Affair, Shanghai, China

Kadcyla And Neratinib for Interception of HER2+ Breast Cancer With Molecular Residual Disease

Phase 2

Recruiting

Conditions: HER2-positive Breast Cancer
Breast Cancer

Interventions: Drug: Neratinib

First Posted Date: 2022-05-24

Last Posted Date: 2025-01-31

Lead Sponsor: University Health Network, Toronto

Target Recruit Count: 15

Registration Number: NCT05388149

Locations: 🇨🇦
University Health Network: Princess Margaret Cancer Centre, Toronto, Ontario, Canada

Testing the Safety and Tolerability of the Anti-cancer Drugs Trastuzumab Deruxtecan and Neratinib for Cancers With Changes in the HER2 Gene

Phase 1

Recruiting

Conditions: Metastatic Malignant Solid Neoplasm
Unresectable Malignant Solid Neoplasm

Interventions: Procedure: Biopsy Procedure
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Echocardiography Test
Procedure: Multigated Acquisition Scan
Drug: Neratinib Maleate
Biological: Trastuzumab Deruxtecan

First Posted Date: 2022-05-13

Last Posted Date: 2025-04-09

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 30

Registration Number: NCT05372614

Locations: 🇺🇸
University of Florida Health Science Center - Gainesville, Gainesville, Florida, United States
🇺🇸
City of Hope Comprehensive Cancer Center, Duarte, California, United States
🇺🇸
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States

and more 15 locations

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

Phase 1

Recruiting

Conditions: HER2 Gene Mutation
Gastric Cancer
Gastrointestinal Cancer

Interventions: Drug: Neratinib Pill
Drug: Fam-Trastuzumab Deruxtecan-Nxki (TDxD)

First Posted Date: 2022-03-10

Last Posted Date: 2025-02-03

Lead Sponsor: Fox Chase Cancer Center

Target Recruit Count: 18

Registration Number: NCT05274048

Locations: 🇺🇸
Stanford Cancer Center, Palo Alto, California, United States
🇺🇸
Roswell Park Comprehensive Cancer Center, Buffalo, New York, United States
🇺🇸
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

Three Antidiarrheal Strategies in HER2+/HR+ Early Breast Cancer Patients Treated With Extended Adjuvant Neratinib

Phase 2

Active, not recruiting

Conditions: Hormone Receptor Positive
HER2 Positive Breast Cancer
Early-stage Breast Cancer

Interventions: Drug: Neratinib
Drug: Loperamide
Drug: Colesevelam

First Posted Date: 2022-02-23

Last Posted Date: 2025-04-01

Lead Sponsor: Spanish Breast Cancer Research Group

Target Recruit Count: 177

Registration Number: NCT05252988

Locations: 🇪🇸
Hospital General Universitario de Elche, Elche, Alicante, Spain
🇪🇸
Hospital Costa del Sol, Málaga, Andalucía, Spain
🇪🇸
Hospital Clínico Universitario Lozano Blesa, Zaragoza, Aragón, Spain

and more 52 locations