Utidelone Capsule Plus Capecitabine (CAP) for Metastatic Breast Cancer

Breast Cancer Recurrent Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Breast Cancer Recurrent
• Breast Neoplasms

• NCT number: NCT06458413
• Study type: Interventional
• Source: Henan Cancer Hospital
• Contact: Min Yan
• Phone: +86 157 1385 7388
• Email: ym200678@163.com
• Status: Recruiting
• Phase: Phase 2
• Start date: June 5, 2024
• Completion date: December 5, 2025