Ontology highlight
ABSTRACT: Background
We have previously demonstrated S-1 is non-inferior to taxane with respect to overall survival as first-line chemotherapy for HER2-negative metastatic breast cancer. We aimed to confirm whether S-1 is also non-inferior to anthracycline-containing regimens in the same setting.Methods
We conducted an open-label, non-inferiority, Phase 3 study. Individuals who had HER2-negative metastatic breast cancer, had received no chemotherapy for advanced disease and had endocrine therapy resistance, were randomly assigned to the anthracycline-containing regimens or S-1. The primary endpoint was overall survival. A pre-planned combined analysis of our two Phase 3 studies was also carried out.Results
We enrolled 230 patients (anthracycline, n = 115; S-1, n = 115). Media
SUBMITTER: Mukai H
PROVIDER: S-EPMC8548517 | biostudies-literature | 2021 Oct
REPOSITORIES: biostudies-literature