Irene (pyrotinib)

P2, N=39, Recruiting, Peking Union Medical College | Trial primary completion date: Jul 2026 --> Jul 2028

P2, N=150, Recruiting, Henan Cancer Hospital | Trial completion date: Apr 2026 --> Jun 2029 | Trial primary completion date: Oct 2025 --> Dec 2028

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.

The updated analysis of the phase 3 PHILA trial confirmed the superiority of pyrotinib in combination with trastuzumab and docetaxel over placebo in combination with trastuzumab and docetaxel in sustaining longer progression-free survival and improving overall survival for initial treatment of HER2 positive metastatic breast cancer. The safety profile remained consistent with interim findings, with no new safety signals identified during extended follow-up. This analysis reinforces the efficacy of this dual anti-HER2 (pyrotinib plus trastuzumab) regimen as an effective treatment strategy for this patient population.

Updated analyses pertaining to PFS and safety were generally aligned with data obtained from initial assessments. The OS outcomes further substantiated that the combination of pyrotinib, trastuzumab, and chemotherapy is an alternative therapeutic regimen for managing HER2-positive MBC with heavy pre-treatment in certain situations, particularly among those with non-visceral metastases.

P=N/A, N=42, Not yet recruiting, Peking University Cancer Hospital & Institute

Two metastatic SDC patients with HER2 amplification responded to HER2 tyrosine kinase inhibitor (TKI) pyrotinib and the combination of trastuzumab and pertuzumab, respectively. Our work underscores the potential of genomic profiling to guide precision therapy in SDC, with HER2-targeted treatments offering promising therapeutic avenues.

Moreover, its ability to traverse the blood-brain barrier confers potential therapeutic advantages in patients with brain metastases. This comprehensive review provides a systematic overview of the pharmacological profile and mechanism of action of pyrotinib, with emphasis on recent clinical trials assessing pyrotinib-based regimens in HER2-positive breast cancer.

P2, N=100, Not yet recruiting, Peking University Cancer Hospital & Institute

P2, N=50, Recruiting, Shanghai Jiao Tong University School of Medicine

Furthermore, CD24 knockdown reduced its expression level by promoting the ubiquitination modification of epidermal growth factor receptor (EGFR), and significantly inhibited its downstream AKT/mTOR signaling pathway. By interacting with EGFR and modulating the mTOR pathway, CD24 acted as a critical regulator of autophagic cell death, thereby enhancing the sensitivity of HER2+ BC cells and reversing Pyrotinib resistance.

P3, N=160, Active, not recruiting, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Recruiting --> Active, not recruiting