Neoadjuvant Pyrotinib plus Trastuzumab and Chemotherapy for Stage I–III HER2-Positive Breast Cancer: A Phase II Clinical Trial

• DOI: 10.1002/onco.13546
• Publication Date: 2020-10-01T05:33:20Z
• Authors: Juncheng Xuhong; Xiaowei Qi; Peng Tang; Linjun Fan; Li Chen; Fan Zhang; Xuanni Tan; Wenting Yan; Ling Zhong; Cheng He; Yan Liang; Lin Ren; Minghao Wang; Yi Zhang; Jun Jiang
• Keywords: Epirubicin; Leukopenia

This is the first trial to explore neoadjuvant therapy of pyrotinib in HER2-positive operable and locally advanced breast cancer, combination with epirubicin plus cyclophosphamide followed by docetaxel trastuzumab. Results primarily showed that trastuzumab was effective safe cancer. A subsequent randomized controlled still warranted confirm these results.The efficacy safety pyrotinib, a new irreversible tyrosine kinase inhibitor (TKI), estimated patients cancer this phase II study, chemotherapy.Between February 19, 2019, November 20, 20 female Chinese stage I-III were assigned receive eight cycles (P) four (E) (C) (T) (H), once every 3 weeks, referred as P + EC-TH.A total 19 completed final surgery. The pathological complete response (tpCR) rate 73.7% (95% confidence interval [CI], 48.8-90.9), no recurrence or metastasis occurred during short-term follow-up period. objective (ORR) 100% CI, 82.4-100). most common adverse events (AEs) diarrhea leukopenia 18 (90%), but grade 5 AEs reported.This study tpCR EC-TH about twice high reported other trials, tolerable side effects.