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
Fulvestrant + Neratinib In Breast Cancer
- Conditions
- ER Positive Breast CancerHER2-negative Breast CancerStage IV (Metastatic) Breast CancerInvasive Breast CancerMetastatic Breast CancerPR-Positive Breast Cancer
- Interventions
- First Posted Date
- 2021-05-25
- Last Posted Date
- 2023-08-01
- Lead Sponsor
- Massachusetts General Hospital
- Registration Number
- NCT04901299
- Locations
- 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
Trial of Pre-operative Neratinib and Endocrine Therapy with Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers
- Conditions
- Breast CancerHER2-positive Breast CancerPR-Positive Breast CancerER Positive Breast Cancer
- Interventions
- First Posted Date
- 2021-05-14
- Last Posted Date
- 2025-02-21
- Lead Sponsor
- Ruth O'Regan
- Target Recruit Count
- 30
- Registration Number
- NCT04886531
- Locations
- 🇺🇸
University of Illinois Cancer Center, Chicago, Illinois, United States
🇺🇸University of Rochester Medical Center, Rochester, New York, United States
🇺🇸Penn State Cancer Institute, Hershey, Pennsylvania, United States
Evaluation of Neratinib for Treatment and Prevention of Subsequent CNS Event(s) in Patients With Brain Metastasis of Advanced HER2 Positive Breast Cancer
- First Posted Date
- 2021-04-23
- Last Posted Date
- 2022-03-02
- Lead Sponsor
- Jules Bordet Institute
- Registration Number
- NCT04856475
Neratinib in Patients With Metastatic Castration-Resistant Prostate Cancer
- Conditions
- Metastatic Prostate AdenocarcinomaProstate CancerCastration-resistant Prostate CancerProstate Cancer Metastatic
- Interventions
- First Posted Date
- 2021-03-04
- Last Posted Date
- 2023-07-11
- Lead Sponsor
- Beth Israel Deaconess Medical Center
- Registration Number
- NCT04781374
- Locations
- 🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸Dana-Farber Cancer Center, Boston, Massachusetts, United States
🇺🇸Massachusetts General Hospital, Boston, Massachusetts, United States
Niraparib and Neratinib in Advanced Solid Tumors With Expansion Cohort in Advanced Ovarian Cancer
- Conditions
- Advanced Solid TumorOvarian Cancer
- Interventions
- First Posted Date
- 2020-08-06
- Last Posted Date
- 2025-05-04
- Lead Sponsor
- Virginia Commonwealth University
- Target Recruit Count
- 18
- Registration Number
- NCT04502602
- Locations
- 🇺🇸
Virginia Commonwealth University, Richmond, Virginia, United States
Targeting EGFR/ERBB2 With Neratinib in Hormone Receptor (HR)-Positive/HER2-negative HER2-enriched Advanced/Metastatic Breast Cancer
- First Posted Date
- 2020-07-07
- Last Posted Date
- 2022-10-25
- Lead Sponsor
- SOLTI Breast Cancer Research Group
- Target Recruit Count
- 12
- Registration Number
- NCT04460430
- Locations
- 🇵🇹
IPO Lisboa, Lisboa, Portugal
🇵🇹Instituto Portugues de Oncologia de Porto Francisco Gentil, EPE, Porto, Portugal
🇪🇸H. Clínico San Cecilio de Granada, Granada, Andalucía, Spain
Real-life Pan-HER-blockade With Neratinib
- Conditions
- Breast Neoplasm
- First Posted Date
- 2020-05-14
- Last Posted Date
- 2023-10-24
- Lead Sponsor
- Pierre Fabre Pharma GmbH
- Target Recruit Count
- 304
- Registration Number
- NCT04388384
- Locations
- 🇩🇪
Community Health Center, Neuss, North Rhine-Westphalia, Germany
🇩🇪Medical Praxis, Freital, Sachsen, Germany
🇨🇭Practice, Biel, Bern, Switzerland
Innovative Trial for Understanding the Impact of Targeted Therapies in NF2-Related Schwannomatosis (INTUITT-NF2)
- Conditions
- Non-vestibular SchwannomaNeurofibromatosis Type 2EpendymomaVestibular SchwannomaMeningioma
- Interventions
- First Posted Date
- 2020-05-05
- Last Posted Date
- 2024-11-18
- Lead Sponsor
- Scott R. Plotkin, MD, PhD
- Target Recruit Count
- 100
- Registration Number
- NCT04374305
- Locations
- 🇺🇸
UCLA Medical Center, Los Angeles, California, United States
🇺🇸University of Miami, Miami, Florida, United States
🇺🇸New York University Langone Medical Center, New York, New York, United States
A Study to Characterize Colon Pathology in Patients With HER2 Amplified Breast Cancer Treated With Neratinib
- Conditions
- HER2 Amplified Breast Cancer
- Interventions
- First Posted Date
- 2020-04-29
- Last Posted Date
- 2023-02-10
- Lead Sponsor
- Puma Biotechnology, Inc.
- Target Recruit Count
- 6
- Registration Number
- NCT04366713
- Locations
- 🇵🇹
Hospital CUF Descobertas, Lisboa, Portugal
Neratinib + Valproate in Advanced Solid Tumors, w/Expansion Cohort in Ras-Mutated Ca
- First Posted Date
- 2019-04-18
- Last Posted Date
- 2025-04-16
- Lead Sponsor
- Virginia Commonwealth University
- Target Recruit Count
- 83
- Registration Number
- NCT03919292
- Locations
- 🇺🇸
Virginia Commonwealth University Massey Cancer Center, Richmond, Virginia, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.