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    DRUG:

    Irene (pyrotinib)

    i
    Other names: SHR-1258, HTI-1001, HTI1001, SHR1258, HTI 1001, SHR 1258
    Company:
    HLB Bio Group, Jiangsu Hengrui Pharma
    Drug class:
    EGFR inhibitor, HER2 inhibitor, HER4 inhibitor
    Related drugs:
    3d
    Treatment of HER2-Positive Brain Metastasis from Cervical Cancer Using Multimodal Therapy Including Pyrotinib: A Case Report. (PubMed, Int J Womens Health)
    This case illustrates successful management of HER2-positive brain metastases from cervical cancer using a multimodal approach combining surgery, radiotherapy, and systemic therapy with pyrotinib and capecitabine. The durable complete response with manageable toxicity underscores the therapeutic potential of HER2-targeted therapy as part of a multimodal regimen; however, further studies are required to validate these findings and optimize personalized treatment strategies.
    Journal
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 overexpression • HER-2 positive + HER-2 overexpression
    |
    capecitabine • Irene (pyrotinib)
    7d
    ctDNA-guided precision therapy with trastuzumab deruxtecan plus pyrotinib in HER2-positive breast cancer brain metastases: a case report. (PubMed, Front Oncol)
    The temporal relationship between molecular and radiologic findings observed here suggests potential value for earlier detection of disease activity, although whether such lead time translates into improved clinical outcomes requires prospective validation. The findings support prospective evaluation of this approach, including the ongoing TROPHY trial investigating this therapeutic approach.
    Journal • Circulating tumor DNA
    |
    HER-2 (Human epidermal growth factor receptor 2) • MET (MET proto-oncogene, receptor tyrosine kinase)
    |
    HER-2 positive • HER-2 amplification • HER-2 mutation • MET amplification
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • Irene (pyrotinib)
    8d
    ESCC-PT: Precision Medicine for Immunotherapy-Resistant Advanced Esophageal Cancer (clinicaltrials.gov)
    P2/3, N=90, Not yet recruiting, Peking University Cancer Hospital & Institute
    New P2/3 trial • Checkpoint inhibition
    |
    PD-L1 (Programmed death ligand 1)
    |
    Gilotrif (afatinib) • Loqtorzi (toripalimab-tpzi) • AiRuiKa (camrelizumab) • AiTan (rivoceranib) • Irene (pyrotinib) • AiRuiKang (dalpiciclib)
    16d
    Pyrotinib Plus Trastuzumab and Chemotherapy for HER2-Positive Early Breast Cancer (clinicaltrials.gov)
    P2, N=182, Recruiting, Hebei Medical University Fourth Hospital
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 amplification
    |
    Herceptin (trastuzumab) • paclitaxel • Irene (pyrotinib) • cyclophosphamide • pegylated liposomal doxorubicin
    24d
    TAYLOR-002: Efficacy and Safety of Culmerciclib Plus Aromatase Inhibitors in a Response-Adapted Neoadjuvant Strategy for Highly Proliferative ER-Positive/HER2-Negative Breast Cancer (clinicaltrials.gov)
    P2, N=45, Recruiting, Second Affiliated Hospital, School of Medicine, Zhejiang University
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    ER positive • HER-2 negative
    |
    Herceptin (trastuzumab) • carboplatin • Perjeta (pertuzumab) • Irene (pyrotinib) • albumin-bound paclitaxel • trastuzumab rezetecan (SHR-A1811) • Saitanxin (culmerciclib)
    28d
    FASCINATE-N: Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (clinicaltrials.gov)
    P2, N=716, Recruiting, Fudan University | Trial completion date: Sep 2028 --> Sep 2029 | Trial primary completion date: Dec 2026 --> Dec 2027
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor) • CD8 (cluster of differentiation 8) • FOXC1 (Forkhead Box C1)
    |
    Herceptin (trastuzumab) • carboplatin • Focus V (anlotinib) • Perjeta (pertuzumab) • AiRuiKa (camrelizumab) • AiTan (rivoceranib) • Irene (pyrotinib) • albumin-bound paclitaxel • cyclophosphamide • letrozole • epirubicin • trastuzumab rezetecan (SHR-A1811) • AiRuiYi (fluzoparib) • Andewei (benmelstobart) • AiRuiKang (dalpiciclib) • goserelin acetate • famitinib (SHR 1020) • Idafang (ivonescimab) • bulumtatug fuvedotin (9MW2821) • AiRuiLi (adebrelimab) • IBI-354 • SHR-4602 • TQB2102 • TQB2868 • anbenitamab repodatecan (JSKN003) • tizetatug rezetecan (SHR-A1921)
    28d
    Dalpiciclib, Anti-HER2 Therapy, and Endocrine Therapy for Hormone-Receptor-Positive, HER2-Positive Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=57, Recruiting, Sun Yat-sen University
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HR positive
    |
    Herceptin (trastuzumab) • Perjeta (pertuzumab) • Irene (pyrotinib) • fulvestrant • AiRuiKang (dalpiciclib) • loperamide
    29d
    A Structured Classification of Pyrotinib-Containing Neoadjuvant Regimens for HER2-Positive Breast Cancer: Efficacy, Safety, and Regimen Selection. (PubMed, Breast Cancer (Dove Med Press))
    Existing studies are generally limited by small sample sizes and a lack of long-term survival data, and high-level evidence directly comparing pyrotinib-based strategies with trastuzumab plus pertuzumab is scarce. Future research should prioritize biomarker-driven patient selection, response-adaptive trial designs, and standardized toxicity management to optimize clinical decision-making.
    Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • Perjeta (pertuzumab) • Irene (pyrotinib)
    1m
    The prognostic value of peripheral blood inflammatory markers in patients with HER2-positive metastatic breast cancer treated with pyrotinib. (PubMed, Front Oncol)
    Kaplan-Meier survival curve and Cox regression model was used to analyze the effect of different levels of NLR and LDH before T-DM1 treatment on the survival of patients. Elevated NLR and LDH were associated with poor PFS and OS. Future data are needed to validate and update our results.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Kadcyla (ado-trastuzumab emtansine) • Irene (pyrotinib)
    1m
    Efficacy and safety of pyrotinib combined with trastuzumab and chemotherapy in patients with HER2-positive locally advanced breast cancer: a multicenter real-world study. (PubMed, Am J Transl Res)
    In a real-world setting the addition of pyrotinib to trastuzumab and chemotherapy significantly improved pathological and radiographic responses and prolonged PFS, albeit with an increased but manageable toxicity profile.
    Journal • Real-world evidence
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • Irene (pyrotinib)
    1m
    Pertuzumab Vs. Pyrotinib in Combination With Trastuzumab and Taxanes for First-Line Treatment of HER2+ MBC: A Multicenter Real-World Study. (PubMed, Cancer Med)
    THPy may provide PFS benefit over THP in HER2+ MBC, with suggestive advantages in patients with de novo stage IV disease and liver metastasis. A higher frequency of diarrhea and other gastrointestinal toxicities was observed in the THPy regimen.
    Clinical • Retrospective data • Journal • Real-world evidence
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • Perjeta (pertuzumab) • Irene (pyrotinib)