ArticleNature communications2023
Antitumour activity of neratinib in patients with HER2-mutant advanced biliary tract cancers.
Article in Nature communications, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01953926 (An Open-Label, Phase 2 Basket Study of Neratinib in Patients With Solid Tumors With Somatic Activating HER Mutations), which is not on this map. Cited by 44 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
An Open-Label, Phase 2 Basket Study of Neratinib in Patients With Solid Tumors With Somatic Activating HER Mutations
Who cites it
44 citing papers in PubMed, 3 syntheses or guidelines pooled it, 76 citations in OpenAlex.
- Comparison of second-line chemotherapy regimens in advanced biliary tract cancer: a systematic review, meta-analysis, and population-based cohort study.International journal of surgery (London, England) · 2026Pooled it
- ESMO Clinical Practice Guideline interim update on the management of biliary tract cancer.ESMO open · 2025Guideline
- Precision Oncology Clinical Trials: A Systematic Review of Phase II Clinical Trials with Biomarker-Driven, Adaptive Design.Cancer research and treatment · 2024Pooled it
- Efficacy and safety of KN026, a bispecific anti-HER2 antibody, in combination with KN046, an anti-CTLA4/PD-L1 antibody, in patients with advanced HER2-positive nonbreast cancer: a combined analysis of a phase Ib and a phase II study.Signal transduction and targeted therapy · 2025Trial
- Tucatinib and Trastuzumab for Previously Treated Human Epidermal Growth Factor Receptor 2-Positive Metastatic Biliary Tract Cancer (SGNTUC-019): A Phase II Basket Study.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023Trial
- Evolving precision: Updates in targeted therapy for cholangiocarcinoma.Hepatology (Baltimore, Md.) · 2026Review
- Molecular and Clinical Determinants of Targeted Therapy Treatment in Biliary Tract Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Article
- Geographic and genetic diversity in gallbladder cancer mutation profiles: insights from a worldwide exome analysis.EBioMedicine · 2026Article
- Advances in In Vitro Diagnostics for Cholangiocarcinoma: From Biomarker Discovery to Artificial Intelligence.International journal of molecular sciences · 2026Review
- Tolerance and response of afatinib combined with tegafur in patients with advanced biliary tract cancer after failure of gemcitabine-based systemic therapy.Discover oncology · 2026Article
- Current Status of Drug Treatment of Cholangiocarcinoma-Updated Progress and Critical Limitations.Pharmaceuticals (Basel, Switzerland) · 2026Review
- Health-related quality of life in biliary tract cancer clinical trials. The current state and future directions.ESMO gastrointestinal oncology · 2026Article
- Recent advances in molecular classification and multimodal treatment of intrahepatic cholangiocarcinoma.World journal of surgical oncology · 2026Review
- Advances in Targeting HER2 across Cancer Subtypes: A Pan-Tumor Approach.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Review
- Amino acid metabolic reprogramming: future prospects for cholangiocarcinoma therapy.Cell death discovery · 2026Review
- Research on Targeted Therapy for Malignant Tumors of the Biliary Tract.OncoTargets and therapy · 2026Review
- Treatment of biliary tract cancer - essentials for clinical practice.Frontiers in oncology · 2026Review
- Response of HER2 positive gallbladder adenocarcinoma to trastuzumab emtansine (T-DM1): a case report and literature review.Frontiers in oncology · 2026Article
- Molecular Alterations and Pathways in Intrahepatic Cholangiocarcinoma: Available Evidence and New Perspectives.International journal of molecular sciences · 2025Review
- 5-HT regulates resistance to aumolertinib by attenuating ferroptosis in lung adenocarcinoma.EMBO molecular medicine · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
28 authors at 16 institutions in 6 countries.
Funding
Abstract
HER2 mutations are infrequent genomic events in biliary tract cancers (BTCs). Neratinib, an irreversible, pan-HER, oral tyrosine kinase inhibitor, interferes with constitutive receptor kinase activation and has activity in HER2-mutant tumours. SUMMIT is an open-label, single-arm, multi-cohort, phase 2, 'basket' trial of neratinib in patients with solid tumours harbouring oncogenic HER2 somatic mutations (ClinicalTrials.gov: NCT01953926). The primary objective of the BTC cohort, which is now complete, is first objective response rate (ORR) to neratinib 240 mg orally daily. Secondary objectives include confirmed ORR, clinical benefit rate, progression-free survival, duration of response, overall survival, safety and tolerability. Genomic analyses were exploratory. Among 25 treatment-refractory patients (11 cholangiocarcinoma, 10 gallbladder, 4 ampullary cancers), the ORR is 16% (95% CI 4.5-36.1%). The most common HER2 mutations are S310F (n = 11; 48%) and V777L (n = 4; 17%). Outcomes appear worse for ampullary tumours or those with co-occurring oncogenic TP53 and CDKN2A alterations. Loss of amplified HER2 S310F and acquisition of multiple previously undetected oncogenic co-mutations are identified at progression in one responder. Diarrhoea is the most common adverse event, with any-grade diarrhoea in 14 patients (56%). Although neratinib demonstrates antitumour activity in patients with refractory BTC harbouring HER2 mutations, the primary endpoint was not met and combinations may be explored.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.