Therapy Detail

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Therapy Name Neratinib
Synonyms
Therapy Description

Nerlynx (neratinib) inhibits the ERBB2 (HER2) receptor as well as EGFR, resulting in decreased proliferation of HER2 and EGFR expressing tumor cells (PMID: 15173008). Nerlynx (neratinib) is FDA approved for use in patients with early stage ERBB2 (HER2)-positive breast cancer following Herceptin (trastuzumab)-based therapy, and in combination with Xeloda (capecitabine) in patients with advanced/metastatic ERBB2 (HER2)-positive breast cancer who have received two or more anti-ERBB2 (HER2) regimens (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Neratinib Nerlynx HKI-272|PB272 HER2 Inhibitor 41 Nerlynx (neratinib) inhibits the ERBB2 (HER2) receptor as well as EGFR, resulting in decreased proliferation of HER2 and EGFR expressing tumor cells (PMID: 15173008). Nerlynx (neratinib) is FDA approved for use in patients with early stage ERBB2 (HER2)-positive breast cancer following Herceptin (trastuzumab)-based therapy, and in combination with Xeloda (capecitabine) in patients with advanced/metastatic ERBB2 (HER2)-positive breast cancer who have received two or more anti-ERBB2 (HER2) regimens (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
PIK3CA H1047R breast cancer sensitive Neratinib Preclinical - Cell culture Actionable In a preclinical study, Nerlynx (neratinib) inhibited growth of breast cancer organoids harboring PIK3CA H1047R in culture (PMID: 37272756). 37272756
PIK3CA H1047R breast cancer sensitive Neratinib Preclinical Actionable In a preclinical study, Nerlynx (neratinib) inhibited survival of transformed breast epithelial cell lines overexpressing PIK3CA H1047R in culture (PMID: 26627007). 26627007
BRAF V600E CBL dec exp high grade glioma predicted - resistant Neratinib Preclinical - Cell culture Actionable In a preclinical study, glioma cell lines harboring BRAF V600E and siRNA mediated knockdown of CBL were resistant to treatment with Nerlynx (neratinib) in culture (PMID: 34433654). 34433654
PIK3CA E545K breast cancer sensitive Neratinib Preclinical Actionable In a preclinical study, Nerlynx (neratinib) inhibited survival of transformed breast epithelial cell lines overexpressing PIK3CA E545K in culture (PMID: 26627007). 26627007
PIK3CA Q546K breast cancer sensitive Neratinib Preclinical Actionable In a preclinical study, Nerlynx (neratinib) inhibited survival of transformed breast epithelial cell lines overexpressing PIK3CA Q546K in culture (PMID: 26627007). 26627007
PIK3CA E542K breast cancer sensitive Neratinib Preclinical Actionable In a preclinical study, Nerlynx (neratinib) inhibited survival of transformed breast epithelial cell lines overexpressing PIK3CA E542K in culture (PMID: 26627007). 26627007
PIK3CA G1049R breast cancer sensitive Neratinib Preclinical Actionable In a preclinical study, Nerlynx (neratinib) inhibited survival of transformed breast epithelial cell lines overexpressing PIK3CA G1049R in culture (PMID: 26627007). 26627007
BRAF G596R PIK3CA E545K colorectal cancer sensitive Neratinib Preclinical Actionable In a preclinical study, Nerlynx (neratinib) inhibited growth of colorectal cancer cells harboring both BRAF G596R and PIK3CA E545K in culture (PMID: 26243863). 26243863
PIK3CA H1047L breast cancer sensitive Neratinib Preclinical Actionable In a preclinical study, Nerlynx (neratinib) inhibited survival of transformed breast epithelial cell lines overexpressing PIK3CA H1047L in culture (PMID: 26627007). 26627007
PIK3CA N345K breast cancer sensitive Neratinib Preclinical Actionable In a preclinical study, Nerlynx (neratinib) inhibited survival of transformed breast epithelial cell lines overexpressing PIK3CA N345K in culture (PMID: 26627007). 26627007

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT05564377 Phase II Selumetinib Binimetinib + Fulvestrant Binimetinib + Palbociclib Nilotinib + Paclitaxel Binimetinib + Fluorouracil + Leucovorin + Oxaliplatin Panitumumab + Sotorasib Binimetinib Fulvestrant Olaparib Olaparib + Selumetinib Alpelisib + Olaparib Neratinib Neratinib + Palbociclib Fluorouracil + Leucovorin + Oxaliplatin Ipatasertib + Paclitaxel Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial Recruiting USA 1
NCT06126276 Phase II Neratinib Neratinib + Palbociclib Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial) Recruiting USA 0
NCT01953926 Phase II Neratinib + Trastuzumab Fulvestrant + Neratinib + Trastuzumab Neratinib Neratinib + Paclitaxel Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations Terminated USA | ITA | GBR | FRA | ESP | CAN | BEL | AUS 5
NCT05919108 Phase II Neratinib Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers Not yet recruiting USA 0
NCT03812393 Phase II Carboplatin + Neratinib + Paclitaxel Neratinib Evaluating the Efficacy of Neratinib on Live Cell HER2 Signaling Transduction Analysis Positive Triple Negative Breast (FACT-2) Active, not recruiting USA 0
NCT01670877 Phase II Neratinib Neratinib + Trastuzumab Fulvestrant + Neratinib + Trastuzumab Fulvestrant + Neratinib Neratinib +/- Fulvestrant in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer Completed USA | CAN 0
NCT02932280 Phase Ib/II Neratinib Safety and Dose Finding Study of Neratinib in Children and Young Adults With Cancer That Has Returned or Not Responded to Treatment Active, not recruiting USA | CAN 0
NCT04781374 Phase II Neratinib Neratinib in Patients With Metastatic Castration-Resistant Prostate Cancer Withdrawn USA 0
NCT02673398 Phase II Neratinib Neratinib in Treating Older Patients With Stage IV HER2-Positive Breast Cancer Completed USA 0
NCT05388149 Phase II Neratinib Kadcyla And Neratinib for Interception of HER2+ Breast Cancer With Molecular Residual Disease Recruiting CAN 0
NCT01494662 Phase II Capecitabine + Neratinib Neratinib HKI-272 for HER2-Positive Breast Cancer and Brain Metastases Active, not recruiting USA 0
NCT04886531 Phase II Anastrozole + Neratinib + Trastuzumab Letrozole + Neratinib + Trastuzumab Neratinib Anastrozole + Neratinib Letrozole + Neratinib Letrozole Anastrozole Anastrozole + Trastuzumab Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers Recruiting USA 0
NCT03289039 Phase II Neratinib Fulvestrant + Neratinib Neratinib +/- Fulvestrant in HER2+, ER+ Metastatic Breast Cancer Terminated USA 0
NCT03094052 Phase II Neratinib Loperamide Crofelemer Neratinib + Trastuzumab Incidence and Severity of Diarrhea in Patients With Stage II-IIIC HER2 Positive Breast Cancer Treated With Trastuzumab and Neratinib Completed USA 0


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