Pyrotinib Plus Trastuzumab and Chemotherapy for HER2-Positive Early Breast Cancer

Summary

This is a single-arm, multicenter clinical study designed to evaluate the efficacy and safety of pyrotinib and trastuzumab combined with pegylated liposomal doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel for injection albumin bound as neoadjuvant therapy in patients with early HER2-positive breast cancer. Eligible patients will receive 8 cycles of neoadjuvant treatment. Pyrotinib will be administered orally once daily, and trastuzumab will be administered intravenously every 3 weeks. During the first 4 cycles, patients will receive pegylated liposomal doxorubicin hydrochloride and cyclophosphamide. During the subsequent 4 cycles, patients will receive paclitaxel for injection albumin bound. The primary outcome is total pathological complete response rate. Secondary outcomes include breast pathological complete response rate, lymph node pathological complete response rate, objective response rate, event-free survival, distant disease-free survival, overall survival, and safety.

Timeline

Start

2024-04-30

Primary completion

2026-12-31

Completion

2029-12-31

Publications

• Background Xuhong J, Qi X, Tang P, Fan L, Chen L, Zhang F, Tan X, Yan W, Zhong L, He C, Liang Y, Ren L, Wang M, Zhang Y, Jiang J. Neoadjuvant Pyrotinib plus Trastuzumab and Chemotherapy for Stage I-III HER2-Positive Breast Cancer: A Phase II Clinical Trial. Oncologist. 2020 Dec;25(12):e1909-e1920. doi: 10.1002/onco.13546. Epub 2020 Oct 20.

Drugs

Indications