drugset / Trial / NCT06764940
A Pivotal Phase II Clinical Trial of Utidelone Injection Plus Capecitabine in HER2-negative Breast Cancer Patients With Brain Metastases
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-07-14
- Primary completion
- 2027-01-15
- Completion
- 2027-07-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Subject | Epothilone D | Small molecule | 25 mg/m2 | Intravenous |
| Subject | Epothilone D | Small molecule | 30 mg/m2 | Intravenous |