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

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.

Trial Details

NCT ID
NCT06764940
Phase
PHASE2
Sponsor
Biostar Pharma, Inc.
Status
RECRUITING
Cancer Type
Brain Cancer
Interventions
  • Utidelone
  • Utidelone in combination with capecitabine
Locations (sample)
  • Duarte, California, United States|34.13945,-117.97729
  • Los Alamitos, California, United States|33.80307,-118.07256
  • Los Angeles, California, United States|34.05223,-118.24368
  • Oxnard, California, United States|34.1975,-119.17705
  • San Diego, California, United States|32.71571,-117.16472

Key Eligibility Criteria

  • Have histologically confirmed HER2-negative metastatic breast cancer. HER2-negative defined as immunohistochemical (IHC) score of 0 or 1+, or IHC2+…
  • Based on screening contrast-enhanced brain MRI, patients must have at least one measurable intracranial lesion according to RECIST 1.1 (≥1.0 cm in …
  • Male or female aged ≥18 years.
  • ECOG PS 0 or 1.

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Brain Cancer Trials on Trialify →