Key clinical point: Patients with human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC) who received pyrotinib along with trastuzumab+docetaxel in the neoadjuvant setting achieved a significant improvement in the total pathological complete response (tpCR) rate without experiencing any unprecedented adverse events (AE).
Major finding: Rate of tpCR was significantly higher in the pyrotinib vs placebo group (41% vs 22%; 1-sided P < .0001). The most common grade 3 or 4 AE in the pyrotinib and placebo treatment arms were diarrhea (44.4% and 5.1%, respectively), neutropenia (18.5% and 20.3%, respectively), and decreased white blood cell count (16.3% and 13.6%, respectively).
Study details: Findings are from the phase 3 PHEDRA study including 355 patients with early/locally advanced HER+ BC who were randomly assigned to receive trastuzumab+docetaxel with either pyrotinib or placebo.
Disclosures: This study was funded by Jiangsu Hengrui Pharmaceuticals Co., Ltd. Four authors declared being former employees of Hengrui. No other conflicts of interest were reported.
Source: Wu J, Jiang Z, Liu Z, Yang B, et al. Neoadjuvant pyrotinib, trastuzumab, and docetaxel for HER2-positive breast cancer (PHEDRA): A double-blind, randomized phase 3 trial. BMC Med. 2022;20(1):498 (Dec 27). Doi: 10.1186/s12916-022-02708-3