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    GENE:

    HER-2 (Human epidermal growth factor receptor 2)

    i
    Other names: ERBB2, CD340, HER-2, HER2, NEU, NGL, V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 2
    1d
    A Study of BL-M07D1 in Combination With Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic HER2-Overexpressing Non-Squamous NSCLC (clinicaltrials.gov)
    P2, N=80, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
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    HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 overexpression
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    Keytruda (pembrolizumab) • trastuzumab brengitecan (BL-M07D1)
    1d
    A Vaccine (H2NVAC) Before Surgery for the Treatment of HER2-Expressing Ductal Carcinoma In Situ (clinicaltrials.gov)
    P1, N=43, Recruiting, Mayo Clinic | Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Dec 2027
    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 expression
    1d
    MiRaDoR: A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population (clinicaltrials.gov)
    P2, N=976, Recruiting, MedSIR | Trial completion date: Dec 2028 --> Jun 2028 | Trial primary completion date: Dec 2028 --> Jun 2028
    Trial completion date • Trial primary completion date • Minimal residual disease • Circulating tumor DNA
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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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    HR positive • HER-2 negative • HR positive + HER-2 negative
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    Prosigna™ Breast Cancer Prognostic Gene Signature Assay • MammaPrint®
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    Verzenio (abemaciclib) • Itovebi (inavolisib) • giredestrant (RG6171)
    1d
    Substudy 06D: Combination Therapies in Second Line (2L) Gastroesophageal Adenocarcinoma (MK-3475-06D/Keymaker-U06) (clinicaltrials.gov)
    P1/2, N=210, Recruiting, Merck Sharp & Dohme LLC | Trial primary completion date: Dec 2026 --> May 2028
    Trial primary completion date
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    HER-2 (Human epidermal growth factor receptor 2) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
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    HER-2 expression
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    Keytruda (pembrolizumab) • paclitaxel • Cyramza (ramucirumab) • patritumab deruxtecan (U3-1402) • Jiataile (sacituzumab tirumotecan)
    1d
    HEROS: Observational, Prospective, Multi-centric Study Exploring HER2 Mutations Incidence and Therapeutic Management in aNSCLC (clinicaltrials.gov)
    P=N/A, N=50, Recruiting, Gruppo Oncologico Italiano di Ricerca Clinica | Trial primary completion date: Jan 2026 --> Jan 2027
    Trial primary completion date
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 mutation
    1d
    A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02) (clinicaltrials.gov)
    P3, N=541, Active, not recruiting, DualityBio Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • mTOR (Mechanistic target of rapamycin kinase)
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    HER-2 positive • HER-2 expression • HER-2 underexpression
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    capecitabine • albumin-bound paclitaxel • trastuzumab pamirtecan (BNT323)
    1d
    Carboplatin and Nab-Paclitaxel With or Without Vorinostat in Treating Women With Newly Diagnosed Operable Breast Cancer (clinicaltrials.gov)
    P2, N=68, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Feb 2026 --> Feb 2027
    Trial completion date
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
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    ER positive • HER-2 negative • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive
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    carboplatin • albumin-bound paclitaxel • Zolinza (vorinostat)
    1d
    Circulating Tumor DNA Based Minimal Residual Disease Detection for Patients With Early-Stage Breast Cancer (clinicaltrials.gov)
    P=N/A, N=350, Suspended, City of Hope Medical Center | Initiation date: Jan 2026 --> May 2026
    Trial initiation date • Minimal residual disease • Circulating tumor DNA
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
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    ER positive • HER-2 negative • HER-2 negative + ER positive
    2d
    M6 metabolite contributes to the efficacy of the Rac/Cdc42 inhibitor MBQ-167 in metastatic breast cancer. (PubMed, Mol Cancer Ther)
    In vivo studies with immunocompromised mice bearing HER2-BM tumors demonstrated that M6 inhibits tumor growth and metastasis to the lungs, livers, and kidneys by ~90%, comparable to MBQ-167. These findings suggest that M6 exhibits potent anticancer properties both in vitro and in vivo, potentially contributing to the sustained efficacy of MBQ-167 in metastatic breast cancer.
    Journal
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    HER-2 (Human epidermal growth factor receptor 2) • RAC1 (Rac Family Small GTPase 1)
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    MBQ-167
    2d
    Dual-Action Theranostic Nanoparticles Delivering Toll-Like Receptor 2 Inhibitors and Chemotherapy Target Breast Cancer Cells and the Tumor Microenvironment. (PubMed, Int J Nanomedicine)
    NP-mediated delivery of a TLR2 inhibitor and doxorubicin produces synergistic anti-cancer effects in breast cancer models. This approach may help overcome chemoresistance and improve therapeutic outcomes, offering a promising strategy for the treatment of advanced breast cancer.
    Journal
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    HER-2 (Human epidermal growth factor receptor 2) • TLR2 (Toll Like Receptor 2)
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    HER-2 positive
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    doxorubicin hydrochloride
    2d
    Basaloid-Solid Adenoid Cystic Carcinoma of the Breast: A Case Report and Literature Review. (PubMed, Case Rep Pathol)
    At 12-month follow-up, local recurrence and bilateral axillary metastases were identified. This case emphasizes the diagnostic challenge of SB-AdCC, its overlap with basaloid carcinoma, and the importance of recognizing its distinct morphological and molecular features.
    Journal
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    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor) • KIT (KIT proto-oncogene, receptor tyrosine kinase) • TP63 (Tumor protein 63)
    2d
    Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer (clinicaltrials.gov)
    P3, N=5018, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Oct 2032 --> Jan 2027
    Trial completion date
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 negative
    |
    Oncotype DX Breast Recurrence Score®Test
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    letrozole • anastrozole • exemestane • Soltamox (tamoxifen citrate)