clinical trial · NCT06764940
A Pivotal Phase II Clinical Trial of Utidelone Injection Plus Capecitabine in HER2-negative Breast Cancer Patients With Brain Metastases
Biostar Pharma, Inc.·phase2·recruiting·n = 120
HER2-negative Breast Cancer Patients With Brain MetastasesUtideloneUtidelone in combination with capecitabineUtidelone in combination with capecitabineUtidelone in combination with capecitabine
brief 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.
started
Jul 14, 2025
primary completion
Jan 15, 2027
completion
Jul 15, 2027
last updated
Nov 28, 2025
official title
A Pivotal Phase II Clinical Trial of Utidelone Injection (UTD1) Plus Capecitabine (CAP) in HER2-negative Breast Cancer Patients With Brain Metastases
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol