Phase II Study of Utidelone Injection with or without Capecitabine for Treating HER2-negative Breast Cancer Patients with Brain Metastases

What this Trial Is About

Researchers are evaluating the effectiveness and safety of utidelone combined with capecitabine in patients with HER2-negative breast cancer that has spread to the brain. This pivotal phase II trial aims to determine how well this combination works inside the brain and throughout the body, focusing on patients with measurable brain metastases confirmed by MRI. The study is sponsored by Biostar Pharma, Inc. and targets adults aged 18 and older with this specific cancer type. The trial includes two stages where patients receive either utidelone alone or utidelone together with capecitabine. Utidelone is given intravenously once daily for five days every 21 days, while capecitabine is taken orally twice daily for up to 14 days in the same 21-day cycle. Different dosing regimens of utidelone 25 or 30 mgm2day are tested in combination groups. The study randomizes participants to one of several groups to compare these treatments and their effects on brain and systemic cancer lesions. Participants will undergo brain MRI scans and other assessments to measure intracranial response rates, progression-free survival, overall survival, and treatment safety over 12 to 24 months. Safety monitoring includes tracking adverse events up to 28 days after treatment ends. Patients must be able to follow the study schedule and provide informed consent. The study will also assess systemic cancer control and quality of life during treatment.

A Pivotal Phase II Clinical Trial of Utidelone Injection Plus Capecitabine in HER2-negative Breast Cancer Patients With Brain Metastases