Neratinib: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Neratinib appears in the FDA drug-label database. Marketed as Nerlynx.
FDA-approved use
NERLYNX is a kinase inhibitor indicated: As a single agent, for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy. ( 1.1 ) In combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting. ( 1.2 ) 1.1 Extended Adjuvant Treatment of Early-Stage Breast Cancer NERLYNX as a single agent is indicated for the extended adjuvant treatment of adult patients with early-stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer, to follow adjuvant trastuzumab based therapy [see Clinical Studies ( 14.1 )] . 1.2 Advanced or Metastatic Breast Cancer NERLYNX in combination with capecitabine is indicated for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting [see Clinical Studies ( 14.2 )] .
Phase breakdown
Conditions being studied
Recruiting trials involving Neratinib
- Adjuvant Therapy With Neratinib in HER2 Positive Early Breast Cancer
- Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor
- I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
- Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers
- Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers
- Using Tumor Models to Determine Treatments
Common questions
Is Neratinib FDA-approved?
Yes, marketed as Nerlynx.
How many recruiting trials involve Neratinib?
6 recruiting trials across 15 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.