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

Summary

This study is a multicenter, two-stage clinical trial to evaluate the efficacy and safety of utidelone in combination with capecitabine in patients with HER2-negative breast cancer with brain metastases. Patients will be enrolled to receive treatment of utidelone alone or in combination with capecitabine. The objectives both in stage I and stage II are to evaluate the intracranial and systemic efficacy and safety of utdelone plus capecitabine for the treatment of HER2-negative breast cancer patients with brain metastases.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• HER2-negative Breast Cancer Patients With Brain Metastases

Eligibility basics and study details

Study type

Interventional

Phase

Phase 2

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Sponsor

Biostar Pharma, Inc.

Last updated on ClinicalTrials.gov

August 21, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites