Pyrotinib plus capecitabine for trastuzumab-resistant, HER2-positive advanced breast cancer (PICTURE): a single-arm, multicenter phase 2 trial.

ABSTRACT:

Background

Patients with human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer and primary resistance to trastuzumab have a poor clinical outcome and lack good evidence to inform clinical decision. This study investigated the efficacy and safety of pyrotinib plus capecitabine in this population.

Methods

This phase 2 trial was conducted at 16 sites in China. Patients received oral pyrotinib 400 mg once daily and capecitabine 1000 mg/m² twice a day on days 1-14 of each 21-day cycle until disease progression or intolerable toxicity. The primary endpoint was investigator-assessed progression-free survival (PFS).

Results

Between June 2019 and September 2021, 100 patients were enrolled with a median age of 51 years (range, 24-69). All pa

SUBMITTER: Cao J 

PROVIDER: S-EPMC10410905 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature