Pyrotinib Combined With Trastuzumab and AI in the First-line Treatment of HER2 Positive/ HR Positive MBC

Phase 2 Unknown 250 enrolled Peking Union Medical College Hospital

RandomizedParallel-groupOpen-labelTreatment

Summary

This study is a randomized, open-label, phase II study, comparing the efficacy and safety of trastuzumab plus aromatase inhibitors, with or without pyrotinib, in the treatment of HR (hormone receptor)+/HER2 (human epidermal growth factor receptor 2) + MBC and inoperable LABC patients.

Timeline

Start: 2019-06-01
Primary completion: 2022-06-01
Completion: 2023-12-01

Publications

Wang C, Lin Y, Zhou Y, Mao F, Zhu H, Guan J, Zhang X, Shen S, Huang X, Chen C, Yao R, Zhao J, Sun Q. Pyrotinib with trastuzumab and aromatase inhibitors as first-line treatment for HER2 positive and hormone receptor positive metastatic or locally advanced breast cancer: study protocol of a randomized controlled trial. BMC Cancer. 2020 Jul 13;20(1):653. doi: 10.1186/s12885-020-07143-2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pyrotinib	Small molecule	400 mg	Oral
Background	Anastrozole	Other / unclassified	1 mg	Oral
Background	Exemestane	Small molecule	25 mg	Oral
Background	Letrozole	Other / unclassified	2.5 mg	Oral
Background	Trastuzumab	Monoclonal antibody	6 mg/kg	Intravenous

Pyrotinib Combined With Trastuzumab and AI in the First-line Treatment of HER2 Positive/ HR Positive MBC

Summary

Timeline

Publications

Drugs

Indications