Neoadjuvant Study of Pyrotinib in Patients With HER2 Positive Breast Cancer

Unknown 100 enrolled Zhejiang Cancer Hospital

RandomizedParallel-groupTriple-blindTreatment

Summary

This is a randomized, double-blind multicenter Phase III study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus docetaxel and Carboplatin versus placebo and trastuzumab plus docetaxel and Carboplatin given as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.

Timeline

Start: 2019-08-01
Primary completion: 2020-07-31
Completion: 2021-07-31

Outcome

Met primary endpoint

paper total pathologic complete response rates were 65.5% (19/29) in the pyrotinib group and 33.3% (10/30) in the placebo group (difference, 32.2%, p = 0.013). PMID 37302393 ↗

Publications

Ding Y, Mo W, Xie X, Wang O, He X, Zhao S, Gu X, Liang C, Qin C, Ding K, Yang H, Ding X. Neoadjuvant Pyrotinib plus Trastuzumab, Docetaxel, and Carboplatin in Early or Locally Advanced Human Epidermal Receptor 2-Positive Breast Cancer in China: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial. Oncol Res Treat. 2023;46(7-8):303-311. doi: 10.1159/000531492. Epub 2023 Jun 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pyrotinib	Small molecule	400 mg	Oral
Background	Carboplatin	Small molecule	5 unknown	—
Background	Docetaxel	Small molecule	75 mg/m2	—
Background	Trastuzumab	Monoclonal antibody	6 mg/kg	Intravenous