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    BIOMARKER:

    HER-2 amplification

    i
    Other names: ERBB2, CD340, HER-2, HER2, NEU, NGL, V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 2
    Entrez ID:
    2064
    Related biomarkers:
    Expression
    Mutation
    CNA
    Fusion
    Others
    Related tests:
    1d
    Analytical Validation and Performance Evaluation of Amplicon-Based Next-Generation Sequencing Assays for Detecting ERBB2 and Other Gene Amplifications in Solid Tumors. (PubMed, Cancers (Basel))
    This study highlights the strengths and limitations of amplicon-based NGS assays in detecting amplifications using real-world data.
    Journal • Next-generation sequencing
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 amplification
    |
    Oncomine™ Comprehensive Assay v3M • Oncomine Focus Assay • Oncomine™ Comprehensive Assay Plus
    3d
    Molecular pathology of gastrointestinal neoplasms (PubMed, Magy Onkol)
    The responsiveness of gastrointestinal stromal tumors to imatinib requires validation via molecular testing. Patients diagnosed with pancreatic cancer may see enhanced survival rates by targeted therapy addressing microsatellite instability and BRCA mutations. In bile duct malignancies, especially intrahepatic cholangiocarcinoma of the small duct variant, the analysis of IDH1 mutations and FGFR2 fusions presents new treatment prospects.
    Review • Journal • BRCA Biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog) • MSI (Microsatellite instability) • FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • CLDN18 (Claudin 18) • BRCA (Breast cancer early onset)
    |
    KRAS mutation • BRAF mutation • HER-2 amplification • NRAS mutation • IDH1 mutation • FGFR2 mutation • FGFR2 fusion • BRCA mutation • IDH1 mutation + FGFR2 fusion
    |
    imatinib
    6d
    The HDAC Inhibitor Entinostat Mediates HER2 Downregulation in Gastric Cancer, Providing the Basis for Its Particular Efficacy in HER2 Amplified Tumors and in Combination Therapies. (PubMed, Cancer Res Treat)
    Concomitantly, cells with high basal or treatment-induced HER2 expression showed most profound sensitivities towards HDACi. These findings may thus provide the basis for HDACi treatment as a therapeutic option (1) particularly valuable in HER2-amplified gastric cancer and (2) particularly useful in combination therapies with HER2 inhibitors.
    Journal • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • MIR205 (MicroRNA 205)
    |
    HER-2 amplification • HER-2 expression
    |
    Jingzhuda (entinostat)
    7d
    Expression of therapy target molecules in esophagogastric junction and Barrett's adenocarcinoma. (PubMed, Gastric Cancer)
    Most EGJ and Barrett's adenocarcinomas may be eligible for molecular targeted therapy. Appropriate patient stratification based on these molecular tests will be important for precision medicine of the EGJ and Barrett's adenocarcinoma.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • CLDN18 (Claudin 18)
    |
    HER-2 positive • HER-2 amplification • HER-2 expression • PD-L1 expression + HER-2 overexpression
    7d
    CRAFT: the NCT-PMO-1602 Phase II Trial (clinicaltrials.gov)
    P2, N=175, Active, not recruiting, German Cancer Research Center | Recruiting --> Active, not recruiting
    Enrollment closed • Tumor mutational burden
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden) • RET (Ret Proto-Oncogene) • PTEN (Phosphatase and tensin homolog) • PI3K (Phosphoinositide 3-kinases)
    |
    BRAF V600E • TMB-H • PD-L1 overexpression • HER-2 overexpression • HER-2 amplification • PIK3CA mutation • BRAF V600 • RET fusion • ALK rearrangement • BRAF V600K • AKT1 mutation • PD-L1 amplification • ALK rearrangement + PIK3CA mutation
    |
    Herceptin (trastuzumab) • Tecentriq (atezolizumab) • Zelboraf (vemurafenib) • Alecensa (alectinib) • Perjeta (pertuzumab) • Cotellic (cobimetinib) • ipatasertib (RG7440) • Itovebi (inavolisib)
    8d
    Resistance mechanisms and prospects of trastuzumab. (PubMed, Front Oncol)
    Specifically, over 50% of patients either do not respond to or develop resistance against trastuzumab.The specific mechanisms of resistance to trastuzumab are currently unclear. This paper aims to review the existing research on the resistance mechanisms of trastuzumab, based on its target, from aspects such as genetic loci, molecular structure, signaling pathways, and the tumor microenvironment and to outline current research progress and new strategies.
    Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 overexpression • HER-2 amplification
    |
    Herceptin (trastuzumab)
    8d
    Testing the Addition of Copanlisib to Usual Treatment (Fulvestrant and Abemaciclib) in Metastatic Breast Cancer (clinicaltrials.gov)
    P1, N=24, Active, not recruiting, National Cancer Institute (NCI) | Phase classification: P1/2 --> P1 | Trial completion date: Mar 2025 --> Jul 2025
    Phase classification • Trial completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PGR (Progesterone receptor) • PTEN (Phosphatase and tensin homolog)
    |
    HER-2 amplification • HER-2 negative • PGR positive • HER-2 negative + PGR positive
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    |
    Verzenio (abemaciclib) • fulvestrant • Aliqopa (copanlisib)
    9d
    Computational approach for counting of SISH amplification signals for HER2 status assessment. (PubMed, PeerJ Comput Sci)
    A one-sided paired t-test confirmed that the differences between the outcomes of the proposed method and the reference standard are statistically insignificant, with p-values exceeding 0.05. This study illustrates how deep learning can effectively automate HER2 status determination, demonstrating improvements over current manual methods and offering a robust, reproducible alternative for clinical practice.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 amplification
    11d
    Molecular testing of gastrointestinal tumours - current status and future prospects. (PubMed, Rozhl Chir)
    In gallbladder and biliary tract cancers, we are mainly looking for IDH1 and IDH2 mutations, FGFR2 gene fusions and mutations, HER2 amplifications or mutations, as well as mutations of BRAF or BRCA1/2. All results should be discussed within the molecular tumor board.
    Review • Journal • BRCA Biomarker • PD(L)-1 Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • MSI (Microsatellite instability) • FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2)
    |
    PD-L1 expression • BRCA2 mutation • BRCA1 mutation • BRAF mutation • HER-2 amplification • NRAS mutation • HER-2 expression • IDH2 mutation • FGFR2 mutation • FGFR2 fusion • HER-2 amplification + PD-L1 expression
    12d
    Trial of Ibrutinib Plus Trastuzumab in HER2-amplified Metastatic Breast Cancer (clinicaltrials.gov)
    P1/2, N=34, Active, not recruiting, US Oncology Research | N=26 --> 34 | Trial completion date: Jun 2024 --> Jan 2025 | Trial primary completion date: Jun 2024 --> Jan 2025
    Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 amplification
    |
    Herceptin (trastuzumab) • Imbruvica (ibrutinib)
    12d
    FOENIX-MBC2 TAS-120-201: A Study of TAS-120 in Patients With Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=168, Completed, Taiho Oncology, Inc. | Active, not recruiting --> Completed
    Trial completion • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • FGFR2 (Fibroblast growth factor receptor 2)
    |
    HER-2 amplification • HER-2 negative • FGFR1 amplification • FGFR2 amplification
    |
    fulvestrant • Lytgobi (futibatinib)
    15d
    Multifaceted impact of HIV inhibitor dapivirine on triple negative breast cancer cells reveals potential entities as targets for novel therapy. (PubMed, Sci Rep)
    Here we show the potent impact of dapivirine on MDA-MB-231 TNBC cells, while NNRTI like nevirapine showed marginal effects...Taken together, dapivirine exhibits the potential to be considered as a repurposed drug for TNBC as monotherapy/combination therapy. Notably, it could also potentially be a treatment for individuals with dual ailments, such as HIV and TNBC, if the clinical outcomes with dapivirine for TNBC become favorable.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor) • TCF3 (Transcription Factor 3) • PCNA (Proliferating cell nuclear antigen)
    |
    HER-2 amplification • EGFR amplification
    16d
    OXEL: Immune Checkpoint or Capecitabine or Combination Therapy as Adjuvant Therapy for TNBC With Residual Disease (clinicaltrials.gov)
    P2, N=45, Completed, Georgetown University | Active, not recruiting --> Completed | Trial completion date: Dec 2022 --> May 2024
    Trial completion • Trial completion date • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 amplification • HER-2 negative
    |
    Opdivo (nivolumab) • capecitabine
    16d
    Epidermal Growth Factor Receptor (EGFR) and SMAD4 negatively correlated in the progression of gallbladder cancer in Eastern Indian patients. (PubMed, BMC Gastroenterol)
    EGFR and SMAD4 expression were found to be negatively correlated in GBC tissue samples. ERBB2 overexpression/amplification was observed in 30% of the GBC samples. We also found a low percentage of GBC samples to show KRAS codon 12 mutation in Indian GBC patient population, as had been previously documented in pancreatic cancers.
    Journal
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • CCND1 (Cyclin D1) • SMAD4 (SMAD family member 4) • TGFB1 (Transforming Growth Factor Beta 1)
    |
    KRAS mutation • EGFR mutation • HER-2 overexpression • HER-2 amplification • HER-2 expression • EGFR expression • MYC expression • CCND1 expression • HER-2 I655V • KRAS exon 3 mutation • SMAD4 expression
    18d
    ERBB2 comprehensive profiling and prognostication in Stage III Colon Cancer: Findings from PETACC8 and IDEA-France cohorts. (PubMed, Gastroenterology)
    The molecular definition of ERBB2-status could represent a cost-effective alternative in stage III CC. ERBB2 alterations and low RNA expression significantly reduce TTR, highlighting the complex role of ERBB2.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 amplification • HER-2 mutation • HER-2 expression
    19d
    Potential of epithelial membrane protein 3 as a novel therapeutic target for human breast cancer. (PubMed, Oncol Rep)
    Suppression of EMP3 expression enhanced sensitivity of BC cells to trastuzumab in vitro...Co‑expression of EMP3 and HER2 was positively associated with ER expression (P=0.028) and tended to be associated with nodal metastasis (P=0.085), however this was not significant. Taken together, the present results supported the potential of targeting EMP3 as a novel therapeutic strategy for human BC via co‑expression of HER2 and EMP3.
    Journal
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
    |
    HER-2 overexpression • HER-2 amplification • ERBB3 expression
    |
    Herceptin (trastuzumab)
    21d
    Gemcitabine, Trastuzumab, and Pertuzumab in the Treatment of Metastatic HER2-Positive Breast Cancer After Prior Trastuzumab/Pertuzumab, or Pertuzumab Based Therapy (clinicaltrials.gov)
    P2, N=45, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Sep 2024 --> Sep 2025 | Trial primary completion date: Sep 2024 --> Sep 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 amplification
    |
    Herceptin (trastuzumab) • gemcitabine • Perjeta (pertuzumab)
    22d
    Unfavorable Prognostic Impact of HER2 2+/FISH-Negativity in Older Patients with HER2-Negative and High-Risk Breast Cancer. (PubMed, Breast Cancer (Dove Med Press))
    In both hormone receptor (HR)-positive (Log rank test, P=0.052) and HR-negative (Log rank test, P=0.125) subgroups, HER2 2+/FISH-negativity showed a marginally significant adverse influence on DFS. In older patients with HER2-negative/high-risk breast cancer undergoing standard adjuvant chemotherapy, our findings suggest that HER2 2+/FISH-negativity has an independent negative impact on prognosis.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 amplification • HER-2 negative • HER-2 negative + HR negative
    23d
    HER2-related biomarkers predict clinical outcomes with trastuzumab deruxtecan treatment in patients with HER2-expressing metastatic colorectal cancer: biomarker analyses of DESTINY-CRC01. (PubMed, Nat Commun)
    Higher levels of HER2 biomarkers in baseline tissue and liquid biopsies, including HER2 status (IHC/ISH), HER2/CEP17 ratio, HER2 ISH signals, HER2 H-score, plasma HER2 (ERBB2) amplification status, HER2 adjusted plasma copy number, and HER2 extracellular domain correlate with antitumor activity (indicated by objective response rate, progression-free survival, and overall survival) of T-DXd. Baseline circulating tumor DNA (ctDNA) analysis suggests antitumor activity of T-DXd in patients who had baseline activating RAS, PIK3CA, or HER2 mutations detected in ctDNA.
    Clinical data • Journal • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    HER-2 positive • HER-2 amplification • PIK3CA mutation • HER-2 mutation • HER-2 expression
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki)
    23d
    Impact of CCND1 amplification on the prognosis of hormone receptor-positive, HER2-negative breast cancer patients-correlation of clinical and pathological markers. (PubMed, Breast Cancer Res Treat)
    CCND1 amplification is a recurring event in breast cancer, occurring most frequently in luminal B-like and HER2-amplified subtypes. A trend toward less favorable outcomes was observed among CCND1-amplified HR-positive, HER2-negative tumors.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • CCND1 (Cyclin D1)
    |
    HER-2 positive • HR positive • HER-2 amplification • HER-2 negative • CCND1 amplification • HR positive + HER-2 negative • HER-2 amplification + HR-positive
    24d
    Expert recommendations on treatment sequencing and challenging clinical scenarios in human epidermal growth factor receptor 2-positive (HER2-positive) metastatic breast cancer. (PubMed, Cancer Treat Rev)
    Based on our clinical experience, we provide a unanimous consensus concerning the treatment of elderly patients as well as those with brain-only metastases, leptomeningeal disease, oligometastatic disease, central nervous system oligo-progressive disease or ERBB2-mutant disease. We also discuss how to combine HER2-targeted therapy with endocrine therapy in patients with HER2-positive/hormone-receptor-positive disease, considerations for potential discontinuation of HER2-targeted therapy in patients with long-term remission and how to treat patients whose metastatic biopsy no longer confirms their HER2-positive status.
    Review • Journal • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HR positive • HER-2 overexpression • HER-2 amplification • EGFR positive • HER-2 overexpression + HR positive • HER-2 positive + HER-2 overexpression
    25d
    Endocervical adenocarcinoma with a micropapillary component: a clinicopathologic analysis in the setting of current WHO classification. (PubMed, Virchows Arch)
    We conclude that the micropapillary structure is an indicator for unfavorable clinical outcomes in HPVA, and can aid in the prognostic stratification of Silva pattern C EAC. The presence of HER2 amplification and specific gene mutations raise the possibility for targeted therapy in the future.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2) • STK11 (Serine/threonine kinase 11) • ARID1A (AT-rich interaction domain 1A) • TERT (Telomerase Reverse Transcriptase)
    |
    TP53 mutation • HER-2 amplification • PIK3CA mutation • ARID1A mutation • STK11 mutation • TERT mutation
    27d
    Efficacy of disitamab vedotin in non-small cell lung cancer with HER2 alterations: a multicenter, retrospective real-world study. (PubMed, Front Oncol)
    The combination of RC48 with platinum+/- bevacizumab resulted in the highest ORR of 71.4% (5 out of 7 patients), with HER2 TKI following at a 50.0% ORR (4 out of 8 patients). RC48, particularly in combination regimens, demonstrates promising efficacy in advanced NSCLC with HER2 alterations. These findings underscore the need for further research to validate RC48's application in clinical practice.
    Retrospective data • Journal • Real-world evidence • Real-world
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 amplification
    |
    Avastin (bevacizumab) • Aidixi (disitamab vedotin)
    28d
    Decoding the pathological and genomic profile of epithelial ovarian cancer. (PubMed, Sci Rep)
    We observed that OC clinical and pathological characteristics of these patients from Tunisia were similar to those of Caucasian patients. We identified frequent CNA in this population that need to be confirmed in other sets from Africa.
    Journal • BRCA Biomarker • PD(L)-1 Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset) • H2AX (H2A.X Variant Histone)
    |
    PD-L1 expression • PD-L1 overexpression • HER-2 amplification • HER-2 expression • HRD • PD-L1 amplification • HER-2 amplification + PD-L1 expression
    29d
    Survival outcomes for HER2-low breast cancer: Danish national data. (PubMed, Acta Oncol)
    HER2-low BC was found to show an improved HR for OS and DRFI compared with HER2 0 BC; however, further studies are need to establish whether it represents a separate biological entity.
    Retrospective data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 amplification • HER-2 expression
    29d
    Generation of chimeric antigen receptor T cells targeting p95HER2 in solid tumors. (PubMed, Nat Commun)
    The combination of p95HER2.CAR T cells and HER2 x CD3 bispecific antibodies lead to a complete regression in three HER2-positive, patient-derived mouse xenografts tumor models. This combination represents a promising strategy to redirect T cells against a subset of HER2-positive tumors.
    Journal • CAR T-Cell Therapy
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 overexpression • HER-2 amplification • HER-2 positive + HER-2 overexpression
    30d
    Navigating the complex landscape of crawling-type gastric adenocarcinomas: Insights and implications for clinical practice. (PubMed, World J Gastrointest Oncol)
    Moreover, a heightened awareness urging the adoption of advanced diagnostic techniques and collaborative approaches is necessary among clinicians and researchers. We aim to contribute to the ongoing discourse in gastrointestinal oncology, emphasizing the importance of recognizing and addressing the complexities associated with rare cancer subtypes such as CRA.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • TP53 (Tumor protein P53) • RHOA (Ras homolog family member A)
    |
    TP53 mutation • HER-2 amplification
    1m
    Tissue-based Next Generation Sequencing (NGS) for Patients with Advanced Solid Tumors: the experience of Verona University Hospital (AIOM 2024)
    Our study provides an example of implementation of molecular profiling in an academic pre-screening program. Further analysis will investigate treatment matching rates, drug access schemes, and their impact on treatment efficacy and survival.
    Clinical • Next-generation sequencing • BRCA Biomarker • Metastases
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ER (Estrogen receptor) • ALK (Anaplastic lymphoma kinase) • TMB (Tumor Mutational Burden) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • FGFR2 (Fibroblast growth factor receptor 2) • PTEN (Phosphatase and tensin homolog) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1)
    |
    BRAF V600E • KRAS mutation • BRCA2 mutation • BRCA1 mutation • EGFR mutation • KRAS G12C • HER-2 amplification • PIK3CA mutation • BRAF V600 • NTRK1 fusion • PTEN mutation • KIT mutation • FGFR2 mutation • RET mutation • MET mutation • KRAS G12 • ESR1 mutation • NTRK1 mutation • BRAF amplification
    |
    FoundationOne® CDx • TruSight Oncology 500 Assay
    1m
    Liquid biopsy-based comprehensive genomic profiling captures tumor heterogeneity and identifies cancer vulnerabilities in patients with RAS/BRAFV600E wild type metastatic colorectal cancer in the CAPRI 2-GOIM trial (AIOM 2024)
    Materials and The phase II CAPRI 2-GOIM trial investigates the efficacy and safety of biomarkerdriven, cetuximab-based, sequence of three treatment lines in mCRC... Baseline plasma-based comprehensive genomic profiling is feasible with high concordance with tissue-based analysis. Liquid biopsy allows identification of misdiagnosed RAS/BRAF alterations and the ultra-selection of pts, which could benefit from anti-EGFR therapies. Finally, potentially actionable gene alterations were found in half of the pts.
    Clinical • Late-breaking abstract • Liquid biopsy • Metastases • Biopsy
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog) • MSI (Microsatellite instability) • PTEN (Phosphatase and tensin homolog) • MAP2K1 (Mitogen-activated protein kinase kinase 1) • NF1 (Neurofibromin 1) • RAS (Rat Sarcoma Virus)
    |
    BRAF V600E • KRAS mutation • HER-2 amplification • NRAS mutation • BRAF V600 • PTEN mutation • BRAF wild-type • NF1 mutation • EGFR amplification + ERBB2 amplification
    |
    FoundationOne® CDx
    |
    Erbitux (cetuximab)
    1m
    Enzyme-free and highly sensitive detection of human epidermal growth factor receptor-2 based on MNAzyme signal amplification in breast cancer. (PubMed, J Mater Chem B)
    The MNAzyme biosensor exhibited a low detection limit of 0.02 ng mL-1 and excellent selectivity. Furthermore, the proposed biosensor can also change the recognition element by changing the aptamer sequence to detect various biomarkers, holding great potential for cancer diagnosis and other related biomedical applications.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 overexpression • HER-2 amplification • HER-2 expression
    1m
    Enhancing antitumor activity of herceptin in HER2-positive breast cancer cells: a novel DNMT-1 inhibitor approach. (PubMed, Discov Oncol)
    This upregulation, in turn, enhanced the cells' sensitivity to HER2 antagonists, indicating that DI-1's mechanism involves inhibiting DNMT-1's recruitment to PTEN's promoter region. Consequently, by increasing PTEN expression, DI-1 amplifies the sensitivity of HER2-positive breast cancer cells to treatment, suggesting its potential as a promising therapeutic strategy in this context.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • PTEN (Phosphatase and tensin homolog) • DNMT1 (DNA methyltransferase 1)
    |
    HER-2 positive • HER-2 amplification • PTEN expression • DNMT1 expression
    |
    Herceptin (trastuzumab)
    1m
    Simultaneous Occurrence of HER2 Mutations in EGFR Mutant NSCLC: Case Reports. (PubMed, JTO Clin Res Rep)
    HER2 mutation and amplification have been identified as distinct molecular targets in lung cancer with different therapeutic and prognostic values. The coexistence of HER2 and EGFR mutations is extremely rare, and therefore, no data exist on the best treatment in these cases.
    Journal
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
    |
    EGFR mutation • HER-2 amplification • HER-2 mutation
    |
    Tagrisso (osimertinib) • Gilotrif (afatinib)
    1m
    Advancing HER2 Stratification: Evaluating the APIS Breast Cancer Subtyping Kit against IHC/ISH for Precise HER2 Quantification (AMP 2024)
    The APIS kit accurately measures HER2/ERBB2 expression. The findings indicate that relying solely on IHC stratification may not be sufficient to predict responses to novel anti-HER2 treatments, like T-Dxd. By leveraging the dynamic range of RNA expression, a ΔCt semi-quantitative scale using additional cut-offs has been developed to enhance the stratification of ERBB2 mRNA expression.
    HER-2 (Human epidermal growth factor receptor 2) • KEAP1 (Kelch Like ECH Associated Protein 1)
    |
    HER-2 amplification • HER-2 expression • HER-2 underexpression
    |
    APIS Breast Cancer Subtyping Kit
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki)
    1m
    Comparative Analysis of Variant Reporting and HRD Performance: Evaluating AVENIO Tumor Tissue CGP Automated Assay Against F1CDx Assay and PGDx elio Test (AMP 2024)
    The AVENIO CGP Assay demonstrated high agreement with 2 established CGP tests, F1CDx and PGDx, in variant reporting, and closely aligned with F1CDx in HRDsig analysis across various tissue types. These results highlight the assay's reliability and demonstrate its utility in translational research.
    Tumor mutational burden
    |
    HER-2 (Human epidermal growth factor receptor 2) • ALK (Anaplastic lymphoma kinase) • TMB (Tumor Mutational Burden) • MSI (Microsatellite instability) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2) • HRD (Homologous Recombination Deficiency)
    |
    HER-2 amplification • HRD • ALK rearrangement • RET rearrangement • HRD signature
    |
    FoundationOne® CDx • AVENIO Tumor Tissue CGP Kit • PGDx elio™ tissue complete assay
    1m
    ERBB2 RNA Expression Levels by NGS-Based Assay as an Alternate Measure for HER2 Overexpression (AMP 2024)
    RNA expression data from NGS panels may offer an additional assessment of HER2 status, as it correlates with ERBB2 DNA-level amplification and differentiates between HER2 0, 1+, 2+, and 3+ cases. Further studies to validate the clinical utility of RNA expression and its correlation with clinical outcome would be required. Our study also elucidates the potential use of RNA sequencing data from routine cancer NGS panels to assess biomarkers in addition to fusions.
    Next-generation sequencing
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 overexpression • HER-2 amplification • HER-2 expression
    |
    TruSight Oncology 500 Assay
    1m
    Validating the APIS Breast Cancer Subtyping Kit: mRNA Expression of ER, PR, HER2, and Ki67 Compared to Immunohistochemistry in 374 Breast Cancer Core Needle Biopsies (AMP 2024)
    A high level of agreement between IHC/ISH and mRNA expression determined by the APIS kit was observed for all markers. Subtype call agreement improved when Ki67 status was excluded, likely due to the challenges in distinguishing high and low Ki67 expression with IHC, leading to ambiguity in differentiating luminal B HER2- from luminal A tumours. Molecular subtyping offers additional insights for guiding breast cancer management decisions.
    Biopsy
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 amplification • HER-2 negative • HER-2 expression • KIT expression • PGR expression
    |
    APIS Breast Cancer Subtyping Kit
    1m
    High Analytical Sensitivity and Specificity of the AVENIO Tumor Tissue CGP Automated Assay for Detecting Genomic Alterations in FFPE Tumor Tissue (AMP 2024)
    The AVENIO CGP assay is an end-to-end platform for tumor genomic profiling, with proven high analytical sensitivity and specificity. Its superb performance makes it well suited for translational research, providing deep genomic analyses to accelerate cancer research.
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • NRAS (Neuroblastoma RAS viral oncogene homolog)
    |
    HER-2 amplification • ALK fusion • NRAS G13
    |
    AVENIO Tumor Tissue CGP Kit • PGDx elio™ tissue complete assay
    1m
    Detection of Novel Fusion Events in Gastric Carcinoma Involving the ARHGAP Gene Family (AMP 2024)
    Our study documents novel fusions in MSS gastric carcinoma involving the ARHGAP family. Patients with these tumors usually lack eligibility for targeted therapies, such as those directed against HER2 and involving immune checkpoint inhibition, and could ultimately benefit from new treatment avenues modulating RHOA activity as a result of ARHGAP fusions.
    Tumor mutational burden • IO biomarker
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    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • TMB (Tumor Mutational Burden) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • ARID1A (AT-rich interaction domain 1A) • CLDN18 (Claudin 18) • PBRM1 (Polybromo 1) • KMT2D (Lysine Methyltransferase 2D) • SMARCA4 (SWI/SNF related, matrix associated, actin dependent regulator of chromatin, subfamily A, member 4) • CTNNB1 (Catenin (cadherin-associated protein), beta 1) • KDM6A (Lysine Demethylase 6A) • RHOA (Ras homolog family member A) • SOX9 (SRY-Box Transcription Factor 9) • ELF3 (E74 Like ETS Transcription Factor 3) • ARHGAP • CDKN1B (Cyclin dependent kinase inhibitor 1B) • CTNND1 (Catenin Delta 1) • ARHGAP42 (Rho GTPase Activating Protein 42)
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    TMB-H • HER-2 amplification • PBRM1 mutation
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    MI Tumor Seek™
    1m
    The efficacy and safety of Trastuzumab combined with pyrotinib in neoadjuvant treatment for HER2-positive eraly breast cancer: A real-world study (ChiCTR2400090883)
    P4, N=40, Not yet recruiting, Affiliated Hospital of North Sichuan Medical College; Affiliated Hospital of North Sichuan Medical College
    New P4 trial • Real-world evidence • Real-world
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    HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 positive • HER-2 amplification
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    Herceptin (trastuzumab) • Irene (pyrotinib)
    1m
    A basket study of Initumab combined with pyrrotinib and triplizumab in the treatment of HER2 variant advanced solid tumors (ChiCTR2400089182)
    P2, N=193, Not yet recruiting, Shanghai East Hospital; Shanghai East Hospital
    New P2 trial • Pan tumor • Metastases
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    HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 amplification • HER-2 mutation
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    Loqtorzi (toripalimab-tpzi)
    1m
    A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Profiles, and Preliminary Efficacy of SYS6023 in Patients with Advanced Solid Tumors (ChiCTR2400089836)
    P1, N=388, Recruiting, Shanghai Chest Hospital; CSPC Megalith Biopharmaceutical Co., Ltd
    New P1 trial • Metastases
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    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ER (Estrogen receptor) • ALK (Anaplastic lymphoma kinase) • PGR (Progesterone receptor) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • NRG1 (Neuregulin 1) • NTRK (Neurotrophic receptor tyrosine kinase)
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    KRAS mutation • EGFR mutation • KRAS G12C • BRAF mutation • HER-2 amplification • HER-2 negative • BRAF V600 • HER-2 expression • ALK positive • MET amplification • ALK fusion • ERBB3 expression • RET mutation • ROS1 fusion • MET mutation • NRG1 fusion • RET rearrangement • KRAS G12 • KRAS amplification • ER expression • PGR expression • ALK-ROS1 fusion • NRG1 fusion • NTRK fusion
    1m
    NCI-2022-04099: Testing the Safety and Tolerability of the Anti-cancer Drugs Trastuzumab Deruxtecan and Neratinib for Cancers With Changes in the HER2 Gene (clinicaltrials.gov)
    P1, N=30, Suspended, National Cancer Institute (NCI) | Recruiting --> Suspended
    Trial suspension • Combination therapy
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    HER-2 (Human epidermal growth factor receptor 2) • CD4 (CD4 Molecule) • CASP3 (Caspase 3)
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    HER-2 positive • HER-2 overexpression • HER-2 amplification • HER-2 mutation • HER-2 L755S • HER-2 A775_G776insYVMA • HER-2 S310F • HER-2 V777L • HER-2 G778_P780dup • HER-2 D769Y • HER-2 L869R • HER-2 V842I • HER-2 H878Y • HER-2 L866M • HER-2 A775 • HER-2 G309A • HER-2 P780-Y781insGSP • HER-2 R678Q • HER-2 R896C • HER-2 T862A • HER-2 YVMA
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    Nerlynx (neratinib) • Enhertu (fam-trastuzumab deruxtecan-nxki)