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our Premium Content: News alerts, weekly reports and conference plannersBIOMARKER:
HER-2 amplification
i
Other names: ERBB2, CD340, HER-2, HER2, NEU, NGL, V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 2
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Related tests:
17h
Tumor genomics in patients younger than 40 years of age with metastatic breast cancer. (PubMed, NPJ Precis Oncol)
OS was shorter among younger recurrent MBC patients [median: 2.8 (≤ 40) vs. 3.6 years ( > 55), p = 0.04], with SNVs in TP53 and PTEN associated with shorter OS. Distinct tumor genomics of young-onset MBC patients suggest differences in tumor biology that should guide investigation of targetable pathways.
Journal
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HER-2 (Human epidermal growth factor receptor 2) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog) • CDH1 (Cadherin 1)
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TP53 mutation • HER-2 amplification • PIK3CA mutation • HER-2 mutation
23h
WBP2 Attenuates Metformin Response in HER2-Positive Breast Cancer Cells by Repressing AMPK Activation and Inducing a Lower AMP:ATP Ratio State Through Enhanced ATP Production. (PubMed, Cells)
This study reported a novel role of WBP2 in cancer metabolism and energetics that contributes new insights into the molecular etiology of cancer. WBP2 may be a biomarker for patient stratification, paving the way towards repurposing metformin for precision oncology.
Journal
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HER-2 (Human epidermal growth factor receptor 2) • WBP2 (WW Domain Binding Protein 2)
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HER-2 positive • HER-2 amplification
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metformin
1d
A Study of NVL-330 in Patients With Advanced or Metastatic HER2-altered NSCLC (HEROEX-1) (clinicaltrials.gov)
P1, N=200, Recruiting, Nuvalent Inc. | N=150 --> 200 | Trial completion date: Mar 2026 --> Feb 2027 | Trial primary completion date: Mar 2026 --> Jan 2027
Enrollment change • Trial completion date • Trial primary completion date • First-in-human
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 amplification • HER-2 exon 20 insertion • HER-2 exon 20 mutation
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NVL-330
3d
Post-op T-DM1 in HER-2+ Salivary Gland Carcinomas (clinicaltrials.gov)
P2, N=55, Recruiting, Dana-Farber Cancer Institute | Trial completion date: Feb 2027 --> Feb 2029 | Trial primary completion date: Feb 2026 --> Feb 2028
Trial completion date • Trial primary completion date
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive • HER-2 amplification • HER-2 expression
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cisplatin • carboplatin • Kadcyla (ado-trastuzumab emtansine)
3d
Correlation between HER2 gene copy number and immunohistochemistry categories in HER2-negative breast cancer: diagnostic utility for differentiating HER2-null, ultralow, and low tumors. (PubMed, J Pathol Transl Med)
HER2 gene copy number was positively correlated with protein expression as reflected by IHC categories. Although HER2 gene copy number was statistically higher in HER2-low than in HER2-null tumors, the substantial overlap in copy number ranges likely limits its utility in distinguishing HER2-low from HER2- null BCs.
Journal
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 amplification • HER-2 negative • HER-2 expression
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Enhertu (fam-trastuzumab deruxtecan-nxki)
4d
A Study of Trastuzumab Deruxtecan in People With Non-Small Cell Lung Cancer (clinicaltrials.gov)
P2, N=14, Recruiting, Memorial Sloan Kettering Cancer Center
New P2 trial
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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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Enhertu (fam-trastuzumab deruxtecan-nxki) • Ogivri (trastuzumab-dkst)
4d
The Utility Of The Thinprep® For Determining Hormone Receptor And Her2 Status In Axillary Lymph Node Fine Needle Aspiration In Metastatic Breast Cancer; Comparison With The Primary Tumor. (PubMed, Acta Cytol)
Conclusions The ER, PgR, and HER2 results obtained using the ThinPrep in axillary lymph node FNAC had lower discordance and higher concordance than majority of studies in the literature. These results demonstrate that axillary lymph node FNAC and ThinPrep can be safely used for accurate treatment selection and diagnosis.
Journal
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 amplification • HER-2 expression
6d
A Two-Arm Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Chinese Participants With HER2-Positive Early Breast Cancer (clinicaltrials.gov)
P3, N=200, Completed, Hoffmann-La Roche | Active, not recruiting --> Completed
Trial completion
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PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
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HER-2 positive • HER-2 amplification • PIK3CA mutation • EGFR positive
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docetaxel • tamoxifen • doxorubicin hydrochloride • cyclophosphamide • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf)
7d
Opti-HER2: De-escalation of Neoadjuvant Treatment (Paclitaxel + HP) in Early HER2+ Breast Cancer (clinicaltrials.gov)
P2, N=186, Active, not recruiting, National Medical Research Radiological Centre of the Ministry of Health of Russia
New P2 trial
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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) • carboplatin • paclitaxel • docetaxel • Perjeta (pertuzumab) • Kadcyla (ado-trastuzumab emtansine)
8d
RECLAIM: Re-challenge Immunotherapy With Cromolyn, TQB2102, and Panpulimab in Immune-Refractory Triple Negative Breast Cancer (clinicaltrials.gov)
P2, N=46, Not yet recruiting, Fudan University
New P2 trial
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
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HER-2 amplification • ER negative
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TQB2102
8d
Real-World Genomic Landscape of Korean Gastric Cancer: Integrating Biomarker Associations and Clinical Outcomes in Metastatic Gastric Cancer. (PubMed, JCO Precis Oncol)
Our findings provide a comprehensive genomic landscape of Korean gastric cancer and underscore the clinical relevance of integrating genomic and established biomarkers to advance precision oncology.
Clinical data • Journal • Real-world evidence • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
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HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden) • MET (MET proto-oncogene, receptor tyrosine kinase) • FGFR2 (Fibroblast growth factor receptor 2) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • ARID1A (AT-rich interaction domain 1A) • CCNE1 (Cyclin E1) • BCOR (BCL6 Corepressor)
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TP53 mutation • TMB-H • HER-2 amplification • PIK3CA mutation • ARID1A mutation • FGFR2 mutation • TMB-L • EGFR positive
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Opdivo (nivolumab)
10d
ATOP TRIAL: T-DM1 in HER2 Positive Breast Cancer (clinicaltrials.gov)
P2, N=82, Active, not recruiting, Dana-Farber Cancer Institute | Trial completion date: Aug 2029 --> Aug 2027 | Trial primary completion date: Aug 2026 --> Mar 2025
Trial completion date • Trial primary completion date
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ER (Estrogen receptor) • PGR (Progesterone receptor)
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HER-2 positive • HER-2 amplification • HER-2 negative
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Kadcyla (ado-trastuzumab emtansine)
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