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    1d
    Testing the Biological Effects of DS-8201a on Patients With Advanced Cancer (clinicaltrials.gov)
    P1, N=62, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2025 --> Jan 2027 | Trial primary completion date: Dec 2025 --> Sep 2025
    Trial completion date • Trial primary completion date
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    CD4 (CD4 Molecule)
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    HER-2 positive • HER-2 amplification • HER-2 expression
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    Enhertu (fam-trastuzumab deruxtecan-nxki)
    1d
    CDK4/6 Inhibitors Combined With Standard Adjuvant Endocrine Therapy in High-Risk, HR+/HER2+ Early Breast Cancer Patients(CHESS) (clinicaltrials.gov)
    P3, N=1903, Recruiting, Fudan University | Not yet recruiting --> Recruiting
    Enrollment open
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    ER (Estrogen receptor) • PGR (Progesterone receptor)
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    HER-2 positive • ER positive • HER-2 amplification • PGR positive
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    tamoxifen • letrozole • exemestane
    1d
    HER2 Protein Overexpression, mRNA Expression, and DNA Amplification Across Solid Tumors: Comparison of Next-Generation Sequencing-Based Assays With Immunohistochemistry. (PubMed, JCO Precis Oncol)
    HER2-positive status in protein, mRNA, and DNA showed concordance in general but varied among tumor types. NGS-based assays, especially WTS, could be a useful predictive tool for HER2 testing in tumor-agnostic settings. Intratumor heterogeneity in HER2 protein expression should be considered when bringing bulk sequencing tests into clinical settings.
    Clinical • Journal • Next-generation sequencing
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    HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 positive • HER-2 overexpression • HER-2 amplification
    1d
    Clinicopathologic and molecular characterization of uterine and ovarian mixed yolk sac tumor and carcinoma/carcinosarcoma: implications for somatic derivation and therapeutics. (PubMed, Virchows Arch)
    Consistent with these findings, two patients derived profound clinical benefit from matched PARP inhibitors or anti-HER2 antibody-drug conjugate. Our findings definitively establish the somatic and clonal nature of these mixed tumors and provide a compelling rationale for molecularly guided treatment.
    Journal • Tumor mutational burden • PARP Biomarker • PD(L)-1 Biomarker • IO biomarker
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    TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • TMB (Tumor Mutational Burden) • PTEN (Phosphatase and tensin homolog) • HRD (Homologous Recombination Deficiency)
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    PD-L1 expression • TP53 mutation • HER-2 amplification • PIK3CA mutation • HER-2 expression • PD-L1 underexpression • PTEN mutation
    1d
    Circulating Lipid Peroxides Associate with More Aggressive Tumor Phenotypes and Increased Risks of Recurrence and Mortality in Breast Cancer Patients. (PubMed, Med Sci (Basel))
    Overweight patients also exhibited higher lipid peroxide levels than eutrophic individuals (1,131,233 ± 59,633 RLU vs. 820,772 ± 57,653 RLU; p = 0.0142). Collectively, these results suggest that circulating lipid peroxides may serve as potential biomarkers for recurrence and death risk in breast cancer, particularly among patients with more aggressive tumor phenotypes.
    Journal
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
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    ER positive • HER-2 amplification
    3d
    Characterization of ESR1 alterations in patients with breast and gynecologic cancers. (PubMed, Breast Cancer Res)
    ESR1 alterations were most frequent in HR + /HER2- BC samples and missense mutations were more frequent in metastatic samples, consistent with their role in ET resistance and disease progression. ESR1 alterations co-occurred with therapeutically relevant alterations in other genes that may help inform clinical decision-making. Gynecologic tumors harbored ESR1 alterations that have prognostic and potentially therapeutic relevance.
    Journal
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • CCND1 (Cyclin D1) • FGF3 (Fibroblast growth factor 3) • CCDC170(Coiled-Coil Domain Containing 170)
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    HER-2 amplification • HER-2 negative • HER-2 mutation • ESR1 mutation
    4d
    Oncogenic Alterations in PI3K Signaling Emulated Optogenetically Recapitulate Some Phenotypic Changes in Mammary Epithelia. (PubMed, ACS Synth Biol)
    Using this tool to mimic the mutation-specific dynamics in MCF10A mammary epithelial cells, we found that PI3K signaling patterns alone were sufficient to reproduce key features of the PIK3CA H1047R-associated EMT phenotype but not the ErbB2-associated proliferative phenotype. These findings suggest that the temporal encoding of pathway activity, not merely its magnitude, can drive some phenotypic changes in oncogenic progression, explain how distinct mutations within a common signaling pathway can produce divergent cellular phenotypes, and provide a workflow for interrogating the functional consequences of changes in signaling dynamics.
    Journal
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    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
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    HER-2 amplification • PIK3CA mutation • HER-2 mutation
    5d
    Therapeutic Strategies to Overcome Payload Resistance of Trastuzumab Deruxtecan in HER2-Positive Cancers. (PubMed, Cancer Sci)
    Moreover, BB-1701, a novel HER2-ADC containing eribulin as a payload, to which N87 AR cells are sensitive, exhibited antitumor effects in N87 AR cells in vitro and in vivo. These findings indicate that ABC transporter-mediated drug efflux is an important mechanism underlying T-DXd resistance in HER2-positive gastric and lung cancer models. Furthermore, our study suggests that both targeting drug efflux pathways and utilizing alternative payloads may be effective strategies for overcoming T-DXd resistance in HER2-positive gastric and lung cancers.
    Journal
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    HER-2 (Human epidermal growth factor receptor 2) • ABCB1 (ATP Binding Cassette Subfamily B Member 1) • ABCG2 (ATP Binding Cassette Subfamily G Member 2)
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    HER-2 positive • HER-2 amplification • HER-2 expression
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    Enhertu (fam-trastuzumab deruxtecan-nxki) • Halaven (eribulin mesylate) • BB-1701
    6d
    Solid Papillary Carcinoma of the Breast-A Case Treated with Total Mastectomy Following Preoperative Diagnosis of Mass-Forming Ductal Carcinoma (PubMed, Gan To Kagaku Ryoho)
    Postoperatively, the patient was started on tamoxifen, and she remains recurrence-free to date. This case underscoring the importance of careful pre-treatment assessment of malignancy.
    Journal
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • SYP (Synaptophysin)
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    ER positive • HER-2 amplification • PGR positive
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    tamoxifen
    7d
    GDC-0084 in Combination With Trastuzumab for Patients With HER2-Positive Breast Cancer Brain Metastases (clinicaltrials.gov)
    P2, N=47, Active, not recruiting, Dana-Farber Cancer Institute | Trial completion date: Nov 2025 --> May 2026
    Trial completion date
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    HER-2 (Human epidermal growth factor receptor 2) • EIF4EBP1 (Eukaryotic translation initiation factor 4E binding protein 1)
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    HER-2 positive • HER-2 overexpression • HER-2 amplification • HER-2 positive + HER-2 overexpression
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    Herceptin (trastuzumab) • paxalisib (GDC-0084)
    8d
    Real-World Treatment Patterns and Outcomes in HER2-Altered Metastatic Breast Cancer Patients in the United States (clinicaltrials.gov)
    P=N/A, N=7933, Not yet recruiting, Boehringer Ingelheim
    New trial • HEOR • Real-world evidence
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    HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 amplification • EGFR positive