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Neratinib

Generic Name
Neratinib
Brand Names
Nerlynx
Drug Type
Small Molecule
Chemical Formula
C30H29ClN6O3
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
Related News

Using Tumor Models to Determine Treatments

Phase 2
Not yet recruiting
Conditions
Pancreatic Ductal Carcinoma
Advanced Cancer
Epithelial Tumor
Interventions
First Posted Date
2025-02-06
Last Posted Date
2025-02-18
Lead Sponsor
University Health Network, Toronto
Target Recruit Count
25
Registration Number
NCT06813079
Locations
🇨🇦

Princess Margaret Cancer Centre, Toronto, Ontario, Canada

Adjuvant Therapy With Neratinib in HER2 Positive Early Breast Cancer

Recruiting
Conditions
HER2-positive Breast Cancer
Interventions
First Posted Date
2024-11-18
Last Posted Date
2024-11-20
Lead Sponsor
Shu Wang
Target Recruit Count
2806
Registration Number
NCT06693024
Locations
🇨🇳

Peking University People's Hospital, Beijing, Beijing, China

Neratinib Tablets Monotherapy for Advanced Solid Tumors With HER2 Mutations

Phase 2
Not yet recruiting
Conditions
Advanced Solid Tumor
Interventions
First Posted Date
2024-07-25
Last Posted Date
2024-07-25
Lead Sponsor
Convalife (Shanghai) Co., Ltd.
Target Recruit Count
60
Registration Number
NCT06519110

Nilatinib Maleate Tablets Combined With Capecitabine in the Treatment of HER2-positive Advanced Esophageal/Esophagogastric Junction/Gastric Adenocarcinoma With Brain Metastases

Phase 2
Not yet recruiting
Conditions
Her2-positive Advanced Esophageal/Esophagogastric Junction/Gastric Adenocarcinoma With Brain Metastasis
Interventions
First Posted Date
2024-04-19
Last Posted Date
2024-04-19
Lead Sponsor
Convalife (Shanghai) Co., Ltd.
Target Recruit Count
28
Registration Number
NCT06374888

Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)

Phase 2
Recruiting
Conditions
Malignant Female Reproductive System Neoplasm
Malignant Solid Neoplasm
Recurrent Malignant Female Reproductive System Neoplasm
Recurrent Malignant Solid Neoplasm
Interventions
Procedure: Biopsy Procedure
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Echocardiography Test
Procedure: Magnetic Resonance Imaging
Procedure: Multigated Acquisition Scan
First Posted Date
2023-11-13
Last Posted Date
2025-05-08
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
70
Registration Number
NCT06126276
Locations
🇺🇸

University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States

🇺🇸

University of South Alabama Mitchell Cancer Institute, Mobile, Alabama, United States

🇺🇸

UC San Diego Health System - Encinitas, Encinitas, California, United States

and more 131 locations

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

Phase 2
Recruiting
Conditions
GastroEsophageal Cancer
Gastric Cancer
Interventions
First Posted Date
2023-10-31
Last Posted Date
2025-04-17
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Target Recruit Count
36
Registration Number
NCT06109467
Locations
🇺🇸

Moffitt Cancer Center, Tampa, Florida, United States

Neratinib and Trastuzumab Biosimilar in Patients with HER2 Mutated Advanced Solid Cancers

Phase 2
Completed
Conditions
Metastatic Cancer
HER2 Gene Mutation
Interventions
First Posted Date
2023-10-16
Last Posted Date
2025-03-18
Lead Sponsor
Korea University Guro Hospital
Target Recruit Count
42
Registration Number
NCT06083662
Locations
🇰🇷

Korea university Guro hospital, Seoul, Korea, Republic of

Neratinib Tablets in the Treatment of Advanced NSCLC With Rare EGFR Mutations

Phase 2
Not yet recruiting
Conditions
NSCLC
Interventions
First Posted Date
2023-09-08
Last Posted Date
2023-09-08
Lead Sponsor
Convalife (Shanghai) Co., Ltd.
Target Recruit Count
42
Registration Number
NCT06029816
Locations
🇨🇳

Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China

Neratinib in Combination With Ruxolitinib in Patients With mTNBC

Early Phase 1
Recruiting
Conditions
Breast Cancer
Metastatic Triple-Negative Breast Carcinoma
Interventions
First Posted Date
2023-08-23
Last Posted Date
2024-10-09
Lead Sponsor
Baylor Research Institute
Target Recruit Count
20
Registration Number
NCT06008275
Locations
🇺🇸

Baylor University Medical Center, Baylor Charles A Sammons Cancer Center, Dallas, Texas, United States

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

Phase 2
Recruiting
Conditions
Advanced Breast Cancer
Interventions
First Posted Date
2023-07-06
Last Posted Date
2023-10-26
Lead Sponsor
Dartmouth-Hitchcock Medical Center
Target Recruit Count
135
Registration Number
NCT05933395
Locations
🇺🇸

Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States

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