A non-inferiority, phase III trial of gemcitabine plus capecitabine versus gemcitabine plus carboplatin as first-line therapy and tumor-infiltrating lymphocytes as a prognostic biomarker in patients with advanced triple-negative breast cancer.

ABSTRACT:

Background

Gemcitabine plus capecitabine (GX) shows survival benefit and manageable safety in patients with advanced triple-negative breast cancer (TNBC) but there is a paucity of phase III trial evidence. We aimed to compare the efficacy and safety of GX with gemcitabine plus carboplatin (GC) as first-line treatment for patients with advanced TNBC and validate the prognostic value of tumor-infiltrating lymphocytes (TILs).

Methods

Patients with advanced TNBC were randomly assigned 1:1 to receive gemcitabine (1000 mg/m²) on days 1 and 8 plus oral capecitabine (1000 mg/m² twice a day) on days 1-14, or gemcitabine (1000 mg/m²) on days 1 and 8 plus carboplatin area under curve 2 on days 1 and 8. The primary endpoint was progression-free survival

SUBMITTER: Liu X 

PROVIDER: S-EPMC11615979 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature