Phase 2 Study of Utidelone Plus Capecitabine for Treating Active Brain Metastases in Women with Triple-Negative Advanced Breast Cancer

What this Trial Is About

Researchers are evaluating the combination therapy of utidelone and capecitabine for treating brain metastases in patients with triple-negative advanced breast cancer. This Phase 2 clinical trial aims to explore the effectiveness and safety of this treatment approach and to find systemic options for managing brain metastases in this condition. Participants receive utidelone intravenously at a dose of 30 mgm2 on days 1 to 5 with a possible 10% dose variation, once every three weeks. Capecitabine is taken orally at 1000 mgm2 twice daily after meals for 14 consecutive days, followed by a 7-day break, making a 21-day treatment cycle. This study has a single treatment arm involving these two drugs combined. During the study, participants will be monitored for treatment response using CNS-ORR assessments according to RANO and RECIST1.1 standards, with evaluations continuing up to 48 months. Researchers will also track progression-free survival related to the central nervous system. Safety and organ function will be regularly checked, and the study includes long-term follow-up to observe disease progression or survival after enrollment.

A Single-arm, Prospective Phase Ⅱ Clinical Study of Utidelone Combined with Capecitabine in the Treatment of Active Brain Metastasis of TNBC