Effects of neratinib: A Synthesis of Findings from 22 Studies

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Original Abstract of the Article

Major Research Findings

Neratinib is an orally administered, small-molecule, irreversible pan-ErbB inhibitor in development for the treatment of ErbB2-positive breast cancer. 6 found that neratinib given for 1 year after trastuzumab-based adjuvant therapy significantly improved invasive disease-free survival in women with early-stage HER2-positive breast cancer. The study 17 assessed the efficacy of neratinib as a single agent in HER2-mutant metastatic disease, showing that while responses are observed, they are often not durable. The study 13 showed that neratinib plays a key role in the treatment of HER2-positive metastatic breast cancer in the third and later lines of treatment.

Benefits and Risks

Benefit Summary

Neratinib is an effective drug for the treatment of HER2-positive breast cancer. 6 showed that neratinib given for 1 year after trastuzumab-based adjuvant therapy significantly improved invasive disease-free survival in women with early-stage HER2-positive breast cancer. The study 13 showed that neratinib plays a key role in the treatment of HER2-positive metastatic breast cancer in the third and later lines of treatment.

Risk Summary

Neratinib can cause side effects. 13 reported that diarrhea, palmar-plantar erythrodysesthesia syndrome, and rash were observed in clinical trials with neratinib.

Comparison of Studies

Commonalities of Studies

Multiple studies have shown that neratinib is an effective drug for the treatment of HER2-positive breast cancer. 6 showed that neratinib given for 1 year after trastuzumab-based adjuvant therapy significantly improved invasive disease-free survival in women with early-stage HER2-positive breast cancer. The study 13 showed that neratinib plays a key role in the treatment of HER2-positive metastatic breast cancer in the third and later lines of treatment.

Differences in Studies

The effectiveness of neratinib may differ depending on the stage of breast cancer and HER2 mutations. 17 studied neratinib as a single agent in HER2-mutant metastatic disease, showing that while responses are observed, they are often not durable.

Consistency and Inconsistencies of Results

Multiple studies have shown that neratinib is an effective drug for the treatment of HER2-positive breast cancer, however, 17 studied neratinib as a single agent in HER2-mutant metastatic disease, showing that while responses are observed, they are often not durable. These results suggest that the effectiveness of neratinib may differ depending on the stage of breast cancer and HER2 mutations.

Precautions for Applying Results to Real Life

Neratinib is an effective drug for the treatment of HER2-positive breast cancer, but it can cause side effects. 13 reported that diarrhea, palmar-plantar erythrodysesthesia syndrome, and rash were observed in clinical trials with neratinib. It is important to follow the doctor's instructions when taking neratinib and consult with your doctor if side effects occur.

Limitations of Current Research

More research is needed on the effectiveness of neratinib in the treatment of HER2-positive breast cancer. Further studies should be conducted considering factors such as dosage, duration, and method of administration. In addition, research should take into account the potential differences in effectiveness based on the stage of breast cancer and HER2 mutations.

Future Research Directions

Clinical trials should be conducted to further investigate the effectiveness of neratinib considering factors such as dosage, duration, and method of administration. It is important to take into account the potential differences in effectiveness based on the stage of breast cancer and HER2 mutations.

Conclusions

Neratinib is a promising drug for the treatment of HER2-positive breast cancer, however, more research is needed to fully understand its effectiveness and potential side effects. It is important to consult with a doctor before taking neratinib.

Literature analysis of 22 papers
Positive Content
20
Neutral Content
0
Negative Content
0
Article Type
5
1
1
5
20
1.

A single-dose, crossover, placebo- and moxifloxacin-controlled study to assess the effects of neratinib (HKI-272) on cardiac repolarization in healthy adult subjects.

Author: HugBruce, AbbasRichat, LeisterCathie, BurnsJaime, SonnichsenDaryl

ErbB2-positive breast cancer treatment
Cardiac repolarization effects

Neratinib, an ErbB inhibitor, showed no significant effects on cardiac repolarization at therapeutic and supratherapeutic concentrations.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

3.

Blood-Brain Barrier in Brain Tumors: Biology and Clinical Relevance.

Author: MoFrancesca, PellerinoAlessia, SoffiettiRiccardo, RudàRoberta

Brain tumor treatment

The blood-brain barrier and brain-tumor barrier make it difficult for cancer drugs to reach brain tumors. This review discusses various techniques to overcome these barriers, including direct injections, drug modifications, and physical disruption methods.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

4.

A single-dose, crossover, placebo- and moxifloxacin-controlled study to assess the effects of neratinib (HKI-272) on cardiac repolarization in healthy adult subjects.

Author: HugBruce, AbbasRichat, LeisterCathie, BurnsJaime, SonnichsenDaryl

ErbB2-positive breast cancer treatment
Cardiac repolarization effects

Neratinib, an ErbB inhibitor, showed no significant effects on cardiac repolarization at therapeutic and supratherapeutic concentrations.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

5.

A feed-forward loop between SorLA and HER3 determines heregulin response and neratinib resistance.

Author: Al-AkhrassHussein, ConwayJames R W, PoulsenAnnemarie Svane Aavild, PaateroIlkka, KaivolaJasmin, PadzikArtur, AndersenOlav M, IvaskaJohanna

Targeted therapy

This study investigates the bidirectional relationship between HER2-HER3 signaling and SorLA, a transmembrane sorting receptor. Heregulin-mediated signaling promotes SorLA transcription, and SorLA interacts with HER3 to stabilize the HER2-HER3 dimer. Loss of SorLA sensitizes anti-HER2 therapy-resistant breast cancer cells to neratinib, highlighting SorLA's potential role in overcoming resistance.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

6.

Overall survival with neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer (ExteNET): A randomised, double-blind, placebo-controlled, phase 3 trial.

Author: HolmesFrankie A, MoyBeverly, DelalogeSuzette, ChiaStephen K L, EjlertsenBent, MansiJanine, IwataHiroji, GnantMichael, BuyseMarc, BarriosCarlos H, SilovskiTajana, ŠeparovićRobert, BashfordAnna, ZotanoAngel Guerrero, DenduluriNeelima, PattDebra, GokmenErhan, GoreIra, SmithJohn W, LoiblSibylle, MasudaNorikazu, TomaševićZorica, PetrákováKatarina, DiPrimeoDaniel, WongAlvin, MartinMiguel, ChanArlene,

This final analysis of the ExteNET trial investigated overall survival in women with early-stage HER2-positive breast cancer who received neratinib or placebo after trastuzumab-based therapy. After a median follow-up of 8.1 years, overall survival was comparable between the two groups. These results suggest that neratinib does not provide a significant overall survival benefit in this setting.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

7.

Neratinib exerts dual effects on cartilage degradation and osteoclast production in Osteoarthritis by inhibiting the activation of the MAPK/NF-κB signaling pathways.

Author: QiuJianxin, JiangTing, YangGuangyong, GongYuhang, ZhangWeikang, ZhengXiaohang, HongZhenghua, ChenHaixiao

OA treatment

This study examines the potential of neratinib, a medication used to treat cancer, as a treatment for osteoarthritis. The research shows that neratinib can protect cartilage and reduce inflammation in the joints, suggesting it may be a promising new treatment option for osteoarthritis.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

8.

Imaging of Endocytic Trafficking and Extracellular Vesicles Released Under Neratinib Treatment in ERBB2<sup>+</sup> Breast Cancer Cells.

Author: SantamariaSara, GaglianiMaria Cristina, BelleseGrazia, MarconiSilvia, LechiaraAnastasia, DameriMartina, AielloCinzia, TagliattiErica, CastagnolaPatrizio, CorteseKatia

ERBB2 reduction

Neratinib is a drug used to treat breast cancer with a specific genetic mutation. This study investigated how neratinib affects the release of extracellular vesicles (EVs) from cancer cells. The results showed that neratinib increased the overall release of EVs and reduced the amount of the mutated protein being transferred through these vesicles. This suggests that neratinib could potentially slow down the spread of breast cancer by limiting the spread of the mutated protein via EVs.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

9.

SHP2 is a multifunctional therapeutic target in drug resistant metastatic breast cancer.

Author: ChenHao, LibringSarah, RuddrarajuKasi Viswanatharaju, MiaoJinmin, SolorioLuis, ZhangZhong-Yin, WendtMichael K

MBC treatment
Tumor growth inhibition

Targeting SHP2, an oncogenic phosphatase, may offer a promising therapeutic approach for metastatic breast cancer (MBC). SHP2 inhibition blocked multiple growth-promoting pathways, including those activated by FGF2, PDGF, and hGF, and reduced pulmonary metastasis and extended survival in mice. Combining SHP2 inhibition with FGFR-targeted kinase inhibitors showed synergistic effects, further highlighting its potential in MBC treatment.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

10.

Antitumour activity of neratinib in patients with HER2-mutant advanced biliary tract cancers.

Author: HardingJames J, Piha-PaulSarina A, ShahRonak H, MurphyJessica J, ClearyJames M, ShapiroGeoffrey I, QuinnDavid I, BrañaIrene, MorenoVictor, BoradMitesh, LoiSherene, SpanggaardIben, ParkHaeseong, FordJames M, ArnedosMónica, StemmerSalomon M, de la FouchardiereChristelle, FountzilasChristos, ZhangJie, DiPrimeoDaniel, SavinCasey, Duygu SelcukluS, BergerMichael F, EliLisa D, Meric-BernstamFunda, JhaveriKomal, SolitDavid B, Abou-AlfaGhassan K

BTC treatment
Diarrhea

Neratinib, a pan-HER tyrosine kinase inhibitor, showed some antitumor activity in patients with biliary tract cancers (BTCs) harboring HER2 mutations, but the primary endpoint of the SUMMIT trial was not met. Diarrhoea was the most common adverse event.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.

Language : English

11.

Neratinib kills B-RAF V600E melanoma via ROS-dependent autophagosome formation and death receptor signaling.

Author: DentPaul, BoothLaurence, PoklepovicAndrew, KirkwoodJohn M

Melanoma cell death
Synergy with HDACi
None reported

This study investigated the impact of neratinib, an ERBB family and MAP4K inhibitor, on melanoma cells expressing B-RAF V600E. Neratinib was found to synergize with HDAC inhibitors to kill melanoma cells and was shown to activate certain pathways while inactivating others, leading to increased autophagy and cell death.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

13.

The role of tyrosine kinase inhibitors in the treatment of HER2+ metastatic breast cancer.

Author: Le DuFanny, DiérasVéronqiue, CuriglianoGiuseppe

CNS metastases
Diarrhoea
Erythrodysesthesia
Rash

This review discusses the efficacy and safety profiles of tyrosine kinase inhibitors (TKIs) used to treat HER2+ metastatic breast cancer (MBC), with a focus on TKIs that target HER2 and other HER family receptors. The review provides guidance on adverse event management and how to incorporate TKIs into the treatment algorithm for HER2+ MBC.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

14.

Antineoplastic kinase inhibitors: A new class of potent anti-amoebic compounds.

Author: SauveyConall, EhrenkauferGretchen, ShiDa, DebnathAnjan, AbagyanRuben

amoebiasis treatment
amoebiasis
drug resistance

Several FDA-approved antineoplastic kinase inhibitors were found to be potent amoebicidal agents against Entamoeba histolytica, including dasatinib, bosutinib, ibrutinib, ponatinib, neratinib, and olmutinib. Ibrutinib showed both amoebicidal and cysticidal properties, offering a potential alternative to current therapeutic strategies.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

15.

Neratinib kills B-RAF V600E melanoma via ROS-dependent autophagosome formation and death receptor signaling.

Author: DentPaul, BoothLaurence, PoklepovicAndrew, KirkwoodJohn M

Melanoma cell death
Synergy with HDACi
None reported

This study investigated the impact of neratinib, an ERBB family and MAP4K inhibitor, on melanoma cells expressing B-RAF V600E. Neratinib was found to synergize with HDAC inhibitors to kill melanoma cells and was shown to activate certain pathways while inactivating others, leading to increased autophagy and cell death.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

16.

Analysis of the pan-Asian subgroup of patients in the NALA Trial: a randomized phase III NALA Trial comparing neratinib+capecitabine (N+C) vs lapatinib+capecitabine (L+C) in patients with HER2+metastatic breast cancer (mBC) previously treated with two or more HER2-directed regimens.

Author: DaiMing Shen, FengYin Hsun, ChenShang Wen, MasudaNorikazu, YauThomas, ChenShou Tung, LuYen Shen, YapYoon Sim, AngPeter C S, ChuSung Chao, KwongAva, LeeKeun Seok, OwSamuel, KimSung Bae, LinJohnson, ChungHyun Cheol, NganRoger, KokVictor C, RauKun Ming, SangaiTakafumi, NgTing Ying, TsengLing Ming, BryceRichard, BebchukJudith, ChenMei Chieh, HouMing Feng

HER2+ breast cancer
Neratinib efficacy

Neratinib, a pan-HER tyrosine kinase inhibitor, has shown efficacy in HER2+ breast cancer. This report provides descriptive analysis results from the Asian subgroup of the NALA study, which investigated the efficacy and safety of neratinib + capecitabine compared to lapatinib + capecitabine in HER2+ metastatic breast cancer patients.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

18.

Neratinib + fulvestrant + trastuzumab for HR-positive, HER2-negative, HER2-mutant metastatic breast cancer: outcomes and biomarker analysis from the SUMMIT trial.

Author: JhaveriK, EliL D, WildiersH, HurvitzS A, Guerrero-ZotanoA, UnniN, BrufskyA, ParkH, WaismanJ, YangE S, SpanggaardI, ReidS, BurkardM E, VinayakS, PratA, ArnedosM, BidardF-C, LoiS, CrownJ, BhaveM, Piha-PaulS A, SugaJ M, ChiaS, SauraC, Garcia-SaenzJ Á, GambardellaV, de MiguelM J, Gal-YamE N, RapaelA, StemmerS M, MaC, HankerA B, YeD, GoldmanJ W, BoseR, PetersonL, BellJ S K, FrazierA, DiPrimeoD, WongA, ArteagaC L, SolitD B

HER2-mutant MBC
Neratinib efficacy

Neratinib is a drug that is used to treat HER2-mutant metastatic breast cancer. A study investigated the efficacy and safety of neratinib in patients with HER2-mutant metastatic breast cancer.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

20.

Determining the Optimal (Neo)Adjuvant Regimen for Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer Regarding Survival Outcome: A Network Meta-Analysis.

Author: CaiYu-Wen, ShaoZhi-Ming, YuKe-Da

Improved survival rate
Cardiac events

Chemotherapy plus trastuzumab and pertuzumab might be the optimal regimen for HER2-positive breast cancer in improving survival rate. However, this dual-target therapy should be monitored closely due to its high risk of inducing cardiac events.

Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

21.

Poziotinib Inhibits HER2-Mutant-Driven Therapeutic Resistance and Multiorgan Metastasis in Breast Cancer.

Author: KalraRashi, ChenChing Hui, WangJunkai, SalamAhmad Bin, DobroleckiLacey E, LewisAlaina, SallasChristina, YatesClayton C, GutierrezCarolina, KaranamBalasubramanyam, AnuragMeenakshi, LimBora, EllisMatthew J, KavuriShyam M

Effective HER2-mutant breast cancer treatment
Not durable responses
Variable response

Neratinib, a pan-HER tyrosine kinase inhibitor, is effective against metastatic breast cancers with HER2 mutations, but responses are variable and often not durable. This study reveals that recurrent HER2 mutations impact endocrine therapy responsiveness, metastasis, and sensitivity to pan-HER TKIs. The study shows that poziotinib, a pan-HER TKI, is more effective than neratinib in treating HER2 mutant metastatic breast cancer, supporting the need for clinical evaluation of poziotinib for this indication.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, U.S. Gov't, Non-P.H.S.Research funding provided by US government agencies other than the Public Health Service.

Language : English

22.

Recent Advances on Epidermal Growth Factor Receptor as a Molecular Target for Breast Cancer Therapeutics.

Author: ShettySwathi R, YeeravalliRagini, BeraTanya, DasAmitava

Epidermal Growth Factor Receptor (EGFR) is a protein that plays a vital role in cell growth and is often overexpressed in breast cancer. EGFR inhibition is a promising target for breast cancer treatment. This review highlights the critical role of EGFR in breast cancer and outlines various approaches for inhibiting EGFR to mitigate breast cancer.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

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