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DRUG:

Irene (pyrotinib)

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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:
1d
New P2 trial
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive • HER-2 amplification
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Herceptin (trastuzumab) • paclitaxel • Irene (pyrotinib) • cyclophosphamide • pegylated liposomal doxorubicin
9d
New P2 trial
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
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ER positive • HER-2 negative
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Herceptin (trastuzumab) • carboplatin • Perjeta (pertuzumab) • Irene (pyrotinib) • albumin-bound paclitaxel • trastuzumab rezetecan (SHR-A1811) • Saitanxin (culmerciclib)
13d
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
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HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor) • CD8 (cluster of differentiation 8) • FOXC1 (Forkhead Box C1)
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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)
14d
New P2 trial
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive • HR positive
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Herceptin (trastuzumab) • Perjeta (pertuzumab) • Irene (pyrotinib) • fulvestrant • AiRuiKang (dalpiciclib) • loperamide
14d
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
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive
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Herceptin (trastuzumab) • Perjeta (pertuzumab) • Irene (pyrotinib)
16d
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
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive
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Kadcyla (ado-trastuzumab emtansine) • Irene (pyrotinib)
19d
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
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive
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Herceptin (trastuzumab) • Irene (pyrotinib)
21d
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
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive
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Herceptin (trastuzumab) • Perjeta (pertuzumab) • Irene (pyrotinib)
21d
New P4 trial • Real-world evidence
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HER-2 positive
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Herceptin (trastuzumab) • Perjeta (pertuzumab) • Irene (pyrotinib) • trastuzumab rezetecan (SHR-A1811)
22d
Cost-effectiveness analysis of the treatment pathway after trastuzumab treatment failure in patients with HER2-positive advanced breast cancer: a chinese health system perspective. (PubMed, BMC Health Serv Res)
In the context of the Chinese health system, none of the three alternative regimens-pyrotinib plus capecitabine, T-DM1, and T-DXd-demonstrated cost-effectiveness relative to lapatinib plus capecitabine at the current WTP threshold.
Journal • HEOR • Cost-effectiveness
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive • EGFR positive
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lapatinib • Kadcyla (ado-trastuzumab emtansine) • Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine • Irene (pyrotinib)
1m
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)