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
- Associated Therapies
- -
Adjuvant Therapy With Neratinib in HER2 Positive Early Breast Cancer
- 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 In Combination With Chemotherapy/Trastuzumab/Pembrolizumab In HER2 Gastroesophageal Cancer
- Conditions
- Interventions
- First Posted Date
- 2023-10-31
- Last Posted Date
- 2024-05-03
- Target Recruit Count
- 36
- Registration Number
- NCT06109467
- Locations
- 🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States
Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor
- Conditions
- 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
Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers
- Conditions
- Interventions
- 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
Personalized Medicine for Advanced Biliary Cancer Patients
- First Posted Date
- 2022-11-14
- Last Posted Date
- 2024-11-26
- Lead Sponsor
- UNICANCER
- Target Recruit Count
- 800
- Registration Number
- NCT05615818
- Locations
- 🇧🇪
Universitair Ziekenhuis Leuven, Leuven, Belgium
🇫🇷CHU Amiens Picardie, Amiens, France
🇫🇷CHU d'Angers, Angers, France
Treatment Patterns of Neratinib in HER2+ EBC in China
- 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
- First Posted Date
- 2022-05-24
- Last Posted Date
- 2023-08-02
- Lead Sponsor
- University Health Network, Toronto
- Target Recruit Count
- 15
- Registration Number
- NCT05388149
- Locations
- 🇨🇦
University Health Network: Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Three Antidiarrheal Strategies in HER2+/HR+ Early Breast Cancer Patients Treated With Extended Adjuvant Neratinib
- Conditions
- Interventions
- First Posted Date
- 2022-02-23
- Last Posted Date
- 2024-11-20
- Lead Sponsor
- Spanish Breast Cancer Research Group
- Target Recruit Count
- 315
- 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
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
- Conditions
- Interventions
- First Posted Date
- 2022-02-17
- Last Posted Date
- 2024-11-27
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 10
- Registration Number
- NCT05243641
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
Neratinib Dose Escalation Regimen for HER2 Positive Early Breast Cancer
- First Posted Date
- 2021-12-13
- Last Posted Date
- 2021-12-13
- Lead Sponsor
- Chinese Academy of Medical Sciences
- Target Recruit Count
- 60
- Registration Number
- NCT05154396
Drug Development Updates
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