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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
    11h
    A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Women With Breast Cancer Who Are Having Hormone Therapy (clinicaltrials.gov)
    P3, N=984, Active, not recruiting, Astellas Pharma Global Development, Inc. | Recruiting --> Active, not recruiting | N=540 --> 984 | Trial completion date: Jun 2027 --> Apr 2028
    Enrollment closed • Enrollment change • Trial completion date
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive
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    tamoxifen
    12h
    Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M05D1 in Subjects With Solid Tumors (clinicaltrials.gov)
    P1, N=160, Recruiting, SystImmune Inc. | N=120 --> 160
    Enrollment change
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    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • MSI (Microsatellite instability) • FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • CLDN18 (Claudin 18) • NTRK (Neurotrophic receptor tyrosine kinase)
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    PD-L1 expression • KRAS mutation • MSI-H/dMMR • HER-2 overexpression • BRAF mutation • HER-2 mutation • IDH1 mutation • CLDN18.2 expression • FGFR2 mutation • FGFR2 fusion • IDH mutation + NTRK fusion • NTRK fusion
    16h
    LaPemERLA: Phase II Lenvatinib and Pembrolizumab in Endocrine Resistant Breast Cancer With Letrozole (clinicaltrials.gov)
    P2, N=40, Recruiting, National Cancer Centre, Singapore | Trial completion date: Dec 2027 --> Dec 2028 | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial completion date • Trial primary 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 amplification • HER-2 negative • PGR positive • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive
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    Keytruda (pembrolizumab) • Lenvima (lenvatinib) • letrozole
    16h
    Dual-Target CAR-NK Cells for Advanced Breast Cancer HER2+ TNBC (clinicaltrials.gov)
    P1/2, N=60, Recruiting, Beijing Biotech
    New P1/2 trial
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    HER-2 (Human epidermal growth factor receptor 2) • MSLN (Mesothelin) • ROR1 (Receptor Tyrosine Kinase Like Orphan Receptor 1)
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    HER-2 positive • HER-2 expression
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    cyclophosphamide • fludarabine IV
    16h
    A Study of Real-World Treatment Patterns and Outcomes Among HR+/HER2- Metastatic Breast Cancer Patients Treated With First-Line CDK4/6 Inhibitors (clinicaltrials.gov)
    P=N/A, N=480, Completed, Novartis Pharmaceuticals
    New trial • HEOR • Real-world evidence
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    18h
    Capecitabine In Combination With Cemiplimab In Patient With Metastatic Breast Cancer (clinicaltrials.gov)
    P1, N=13, Completed, H. Lee Moffitt Cancer Center and Research Institute | Active, not recruiting --> Completed
    Trial completion
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
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    HR positive • HER-2 negative
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    capecitabine • Libtayo (cemiplimab-rwlc)
    20h
    TSL-B2276-1-01: A Study of STRO-002 in Chinese Adults With Epithelial Ovarian Cancer and Other Advanced Malignant Solid Tumors (clinicaltrials.gov)
    P1/2, N=19, Completed, Tasly Pharmaceutical Group Co., Ltd | Recruiting --> Completed | N=132 --> 19 | Trial completion date: Dec 2027 --> Dec 2025 | Trial primary completion date: Dec 2026 --> Jun 2025
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date
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    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
    |
    HER-2 negative
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    luveltamab tazevibulin (STRO-002)
    22h
    TRIFOUR: Nadunolimab in Combination With Gemcitabine Plus Carboplatin in Patients With Advanced Triple Negative Breast Cancer. (clinicaltrials.gov)
    P1/2, N=117, Active, not recruiting, Cantargia AB | Trial primary completion date: Jun 2025 --> Apr 2026
    Trial primary completion date • BRCA Companion diagnostic • PARP Companion diagnostic
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    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor) • PGR (Progesterone receptor) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset) • CD4 (CD4 Molecule)
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    BRCA2 mutation • BRCA1 mutation • HER-2 negative • HER-2 negative + HR negative • HER-2 negative + HR negative + BRCA mutation
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    PD-L1 IHC 22C3 pharmDx • Prosigna™ Breast Cancer Prognostic Gene Signature Assay
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    carboplatin • gemcitabine • nadunolimab (CAN04)
    23h
    Clinical Studies of TQB2930 Injection for the Treatment of Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=178, Not yet recruiting, Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
    New P1/2 trial
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    HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 positive • HER-2 expression • HER-2 underexpression
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    TQB2102 • TQB2930
    1d
    Acute Pancreatitis as the Initial Presentation of Metastatic Breast Cancer Due to Malignant Hypercalcemia: A Case Report. (PubMed, Cureus)
    Despite intensive treatment with intravenous hydration and zoledronic acid, neurological deterioration occurred; hence, after 25 days of hospitalization, the patient was discharged for home-based palliative care at the family's request. This case highlights the importance of considering metastatic malignancies, particularly breast cancer, in patients with pancreatitis of unclear etiology and severe hypercalcemia.
    Journal
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    EGFR positive
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    zoledronic acid
    1d
    Distinct biological and molecular characteristics of breast cancer in young women: a narrative review. (PubMed, Ann Med Surg (Lond))
    This review synthesizes current knowledge on the unique tumor biology of breast cancer in young women, highlighting the need for precision oncology approaches that account for age-related tumor behavior. Enhanced characterization of this population may ultimately improve survival outcomes and quality of life for young women affected by breast cancer.
    Review • Journal • BRCA Biomarker • IO biomarker
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    HER-2 (Human epidermal growth factor receptor 2) • TP53 (Tumor protein P53) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
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    HER-2 positive • TP53 mutation • BRCA2 mutation • BRCA1 mutation
    1d
    HR+/HER2- breast cancer brain metastases treated with definitive local therapy: a focus on endocrine sensitivity and incidence of leptomeningeal disease. (PubMed, Neurooncol Adv)
    Patients with endocrine-sensitive disease at the time of BrM diagnosis had a longer brain-specific progression-free survival (7 mo versus 5 months, P = .004) and overall survival (24 months versus 5 mo, P  = .002) compared with those with endocrine resistance. Most patients with HR+/HER2- BrM have endocrine-resistant disease, with an unexpectedly high likelihood of developing LMD.
    Journal
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative