NCT06764940

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

A Pivotal Phase II Clinical Trial of Utidelone Injection (UTD1) Plus Capecitabine (CAP) in HER2-negative Breast Cancer Patients With Brain Metastases

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Biostar Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HER2-negative Breast Cancer Patients With Brain Metastases

Interventions

Type	Name	Description
DRUG	Utidelone	Utidelone 30 mg/m2/d i.v, once a day for 5 consecutive days, every 21 days as a treatment cycle.
DRUG	Utidelone in combination with capecitabine	UTD1 25 mg/m2/d i.v, once a day for 5 consecutive days, every 21 days as a treatment cycle plus capecitabine 1000 mg/m2 orally twice a day, for 1 to 14 days, 21 days as a treatment cycle.
DRUG	Utidelone in combination with capecitabine	Utidelone 30 mg/m2/d i.v, once a day for 5 consecutive days, every 21 days as a treatment cycle plus capecitabine 1000 mg/m2 orally twice a day, for 1 to 14 days, 21 days as a treatment cycle.
DRUG	Utidelone in combination with capecitabine	Utidelone 25 mg/m2/d or 30 mg/m2/d i.v, once a day for 5 consecutive days, every 21 days as a treatment cycle plus capecitabine 1000 mg/m2 orally twice a day, for 1 to 14 days, 21 days as a treatment cycle.

Timeline

• Start date: 2025-07-14
• Primary completion: 2027-01-15
• Completion: 2027-07-15
• First posted: 2025-01-09
• Last updated: 2025-11-28

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated drug study