Irene (pyrotinib)

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

Bayesian network meta-analysis (NMA) was conducted to integrate direct and indirect comparisons, addressing the lack of head-to-head trials. Eleven studies (2 RCTs, 9 retrospective; 826 patients) evaluated four treatment strategies: pyrotinib + RT, pyrotinib alone, RT alone, and lapatinib + RT. In contrast, lapatinib + RT appeared to offer limited benefit and a higher risk of SAEs. Further randomized controlled trials are needed to validate these findings.

P=N/A, N=200, Not yet recruiting, The First Affiliated Hospital of Xi'an Jiaotong University; The First Affiliated Hospital of Xi'an Jiaotong University

P=N/A, N=90, Not yet recruiting, The First Affiliated Hospital of Anhui Medical University; The First Affiliated Hospital of Anhui Medical University

P=N/A, N=43, Not yet recruiting, Beijing Cancer Hospital; Beijing Cancer Hospital

Patients with stage II-III HER2-positive breast cancer were randomized (1:1) to receive TPPy or TP alongside weekly nab-paclitaxel for 12 weeks. The most common grade ≥3 adverse events in the TPPy and TP groups were diarrhea (58.1% vs. 0%) and neutropenia (23.6% vs. 15.1%). In conclusion, triple HER2 blockade did not improve tpCR rates compared with dual blockade but was associated with greater toxicity, particularly diarrhea.

A subgroups comparison found that significant differences were observed in patients who had not used lapatinib (P = 0.016), had a number of metastatic sites ≤ 2 (P = 0.011), were intolerant to trastuzumab (P = 0.004), and were on first-line pyrotinib treatment (P = 0.036), with these patients having median progression-free survival lengths of 13.0 months, 15.9 months, 23.5 months, and 23.5 months, respectively. In addition, a rare positive fecal occult blood profile (5.4%) was observed. Pyrotinib-based regimens have shown satisfactory clinical efficacy in HER2-positive stage III/IV BC patients, and pyrotinib is well tolerated with manageable adverse events.

P2, N=200, Recruiting, Second Affiliated Hospital, School of Medicine, Zhejiang University

P2, N=60, Recruiting, Shanghai Jiao Tong University School of Medicine

P2/3, N=113, Active, not recruiting, Hebei Medical University Fourth Hospital | Not yet recruiting --> Active, not recruiting | N=280 --> 113 | Trial completion date: Mar 2024 --> Dec 2026 | Trial primary completion date: Mar 2022 --> Dec 2026

The most frequently combined chemotherapy was vinorelbine (83/90,92.2%). The most frequently concomitant targeted drug was pyrotinib (70/90,77.8%)...Inetetamab offers a promising option and a manageable safety profile for HER2-positive MBC who pretreated with multiple-line therapies. Meanwhile, inetetamab plus small-molecule TKIs regimens shows good anti-tumor efficacy for MBC with brain metastases, which deserves further validation in a larger group trial.