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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:
    8d
    A real-world study on treatment after TKI progression in HER2-positive MBC. (PubMed, Ther Adv Med Oncol)
    All patients received anti-HER2 TKI therapy (including pyrotinib and lapatinib) in 28-day cycles. No unexpected toxic effects were reported. After progression following TKI therapy, T-DXd exhibited notable antitumor activity, although no significant efficacy differences were observed among ADC, mAb, and TKI groups.
    Journal • Real-world evidence
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    HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 positive
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    lapatinib • Enhertu (fam-trastuzumab deruxtecan-nxki) • Irene (pyrotinib)
    13d
    Rare overlap of subtype and phenotype: HER2-positive pleomorphic invasive lobular carcinoma presenting with an inflammatory breast cancer phenotype: a case report and targeted treatment strategy. (PubMed, Front Oncol)
    The patient received first-line docetaxel, trastuzumab, and pyrotinib (PyroHT) and achieved a partial response; however, progression was observed after ten cycles. Following multidisciplinary review, her treatment was changed to trastuzumab deruxtecan (T-DXd), resulting in significant symptom relief and radiologic regression of the breast lesions...Sequential HER2-targeted therapy provided meaningful clinical benefit, though resistance ultimately developed. We present the case of a 53-year-old woman with HER2-positive advanced PLC presenting with an IBC phenotype, providing insight into the diagnostic process and treatment course in this rare clinical scenario.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 amplification
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    docetaxel • Enhertu (fam-trastuzumab deruxtecan-nxki) • Irene (pyrotinib)
    18d
    A multicenter, single-arm phase II clinical study of eribulin combined with inituzumab and pyrotinib in the treatment of HER2-positive advanced breast cancer (ChiCTR2600121825)
    P2, N=76, Recruiting, Fifth Affiliated Hospital, Sun Yat-Sen University; Fifth Affiliated Hospital, Sun Yat-Sen University
    New P2 trial
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 expression
    |
    Irene (pyrotinib) • Halaven (eribulin mesylate) • TheraCIM (nimotuzumab)
    19d
    A Multicenter, Open-Label, Randomized, Phase II Clinical Trial of Trastuzumab Rezetecan-based Therapy for Brain Metastases in HER2-Positive Breast Cancer (ChiCTR2600120221)
    P2, N=108, ChongQing university cancer hospital; ChongQing university cancer hospital
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 amplification
    |
    Herceptin (trastuzumab) • Focus V (anlotinib) • capecitabine • Irene (pyrotinib) • trastuzumab rezetecan (SHR-A1811)
    19d
    A Randomized, Open-Label Trial of Trastuzumab Combined with Pyrotinib and Taxanes (THPy) versus Trastuzumab Combined with Pertuzumab and Taxanes (THP) as First‑Line Treatment for Advanced HER2‑Positive Breast Cancer (ChiCTR2500101511)
    P4, N=568, Recruiting, Anhui Provincial Cancer Hospital; Anhui Provincial Cancer Hospital | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • Perjeta (pertuzumab) • Irene (pyrotinib)
    21d
    SHR-A1811-II-203: A Trial of Injectable SHR-A1811 in Combination With Pyrotinib or SHR-1316 in Subjects With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=324, Recruiting, Jiangsu HengRui Medicine Co., Ltd. | Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Nov 2023 --> Dec 2026
    Trial completion date • Trial primary completion date
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    Irene (pyrotinib) • trastuzumab rezetecan (SHR-A1811) • AiRuiLi (adebrelimab)
    27d
    Association between diarrhea and survival in patients with HER2-positive advanced breast cancer treated with pyrotinib-based therapy: A landmark analysis from the real-world PRETTY study. (PubMed, Breast)
    For patients with HER2-positive advanced breast cancer, diarrhea that occurs during pyrotinib-based therapy maybe a prognostic marker of longer OS.
    Journal • Real-world evidence
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Irene (pyrotinib)
    27d
    Artificial Intelligence Model-Guided Neoadjuvant Anti-HER2 Targeted Therapy (clinicaltrials.gov)
    P3, N=280, Not yet recruiting, Fudan University
    New P3 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Irene (pyrotinib)
    1m
    Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing (clinicaltrials.gov)
    P2, N=39, Recruiting, Peking Union Medical College | Trial primary completion date: Jul 2026 --> Jul 2028
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    carboplatin • Perjeta (pertuzumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • Lenvima (lenvatinib) • AiRuiKa (camrelizumab) • AiTan (rivoceranib) • Piqray (alpelisib) • Irene (pyrotinib) • albumin-bound paclitaxel • abiraterone acetate • fulvestrant • Aidixi (disitamab vedotin) • exemestane • Padcev (enfortumab vedotin-ejfv) • bicalutamide • Kaitanni (cadonilimab) • goserelin acetate • Qibeian (iparomlimab/tuvonralimab) • Yidafan (ivonescimab) • iparomlimab (QL1604) • leuprolide acetate for depot suspension • Entyvio (vedolizumab)
    1m
    REIN: Study of SHR-A1811 in HER2-expression Advanced Breast Cancer With Brain Metastases (clinicaltrials.gov)
    P2, N=150, Recruiting, Henan Cancer Hospital | Trial completion date: Apr 2026 --> Jun 2029 | Trial primary completion date: Oct 2025 --> Dec 2028
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Avastin (bevacizumab) • Irene (pyrotinib) • trastuzumab rezetecan (SHR-A1811)
    1m
    Exploring tyrosine kinase inhibitors for HER2-positive breast cancer: comprehensive review on a complete pharmacology-molecular mechanisms, safety profiles, and insights from preclinical and clinical studies. (PubMed, Clin Transl Oncol)
    They have demonstrated substantial improvements in survival-free and life expectancy of patients, establishing them as a standard treatment modality. The ongoing development of novel tyrosine kinase inhibitors and their strategic integration into personalized treatment regimens will shape the evolving landscape of breast cancer therapy.
    Preclinical • Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    lapatinib • Nerlynx (neratinib) • Irene (pyrotinib)