Efficacy and safety of pyrotinib in patients with previously treated HER2-positive non-breast solid tumors: a phase 2, open-label basket trial.

ABSTRACT:

Background

Amplification/overexpression of the human epidermal growth factor receptor 2 (HER2) gene drives cell proliferation, differentiation, and migration of breast cancer. However, HER2-targeted therapies are not standard treatment for HER2-positive non-breast solid tumors currently. This phase II open-label basket trial evaluated pyrotinib's efficacy and safety in patients with non-breast solid tumors.

Methods

Patients with previously treated HER2-positive advanced non-breast solid tumors were enrolled at Zhongshan Hospital, Fudan University. All participants received pyrotinib in 21-day cycles. Primary endpoint was objective response rate (ORR) at 6 weeks, assessed per RECIST version 1.1. Circulating tumor DNA (ctDNA) analysis was conducted to identify biomarkers of ef

SUBMITTER: Zhou H 

PROVIDER: S-EPMC12611345 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature