drugset / Trial / NCT07684456

Efficacy and Safety of Utidelone Capsule and Utidelone Injection in Patients With HER-2 Negative Advanced Breast Cancer

NCT07684456

Phase 3 Not yet recruiting 308 enrolled Beijing Biostar Pharmaceuticals Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is a randomized controlled study.The primary objective is to evaluate the Progression-Free Survival(PFS) of Utidelone Capsule combined with Capecitabine compared with Utidelone Injection combined with Capecitabine in patients with HER-2 negative advanced breast cancer.

Timeline

Start
2026-08-01
Primary completion
2028-03-01
Completion
2029-03-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Epothilone D Small molecule 30 mg/m2 Oral
Subject Epothilone D Small molecule 60 mg/m2 Oral
Background Capecitabine Small molecule 1000 mg/m2