NCT06458413

Utidelone Capsule Plus Capecitabine (CAP) for Metastatic Breast Cancer

:Single-arm, Phase II Clinical Trial of Utidelone Capsule Plus Capecitabine (CAP) in Patients With Metastatic Breast Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Min Yan, MD · Other Government
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study aims to investigate the efficacy and safety of utidelone capsule plus Capecitabine in the treatment of advanced breast cancer , and thus provides a new systemic treatment strategy for those patients. This study was a single-arm, phase II study of patients with recurrent or metastatic HER2-negative breast cancer who had previously received chemotherapy regimens containing taxanes and/or anthracyclines were treated with a combination of utidelone capsules and capecitabine. The main objective was to explore the efficacy and safety of the combined regimen.

Detailed description

Patients with recurrent or metastatic HER2 negative breast cancer who have previously received chemotherapy containing taxanes and/or anthracyclines will receive combined treatment with utidelone capsule and capecitabine. Utidelone Capsule: 60mg/m2/d, once daily, oral on an empty stomach, continuously administered for 1-5 days; Capecitabine tablets: 1000mg/m2, twice a day (daily dose 2000mg/m2), once in the morning and once in the evening, taken orally within 30 minutes after meals, and continuously administered for 14 days from day 1 to day 14. Every 21 days is a cycle until disease progression, intolerable adverse events occur, subjects voluntarily withdraw, or the researcher determines that medication must be terminated.

Conditions

• Breast Cancer Recurrent

Interventions

Type	Name	Description
DRUG	Utidelone Capsule Plus Capecitabine	Utidelone Capsule: 60mg/m2/d, once daily, oral on an empty stomach, continuously administered for 1-5 days; Capecitabine tablets: 1000mg/m2, twice a day (daily dose 2000mg/m2), once in the morning and once in the evening, taken orally within 30 minutes after meals, and continuously administered for 14 days from day 1 to day 14. Every 21 days is a cycle .

Timeline

• Start date: 2024-06-05
• Primary completion: 2025-06-05
• Completion: 2025-12-05
• First posted: 2024-06-13
• Last updated: 2024-06-13

Locations

1 site across 1 country: China