RecruitingPhase 2NCT06458413

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

Sponsor

Min Yan, MD

Enrollment

40 participants

Start Date

Jun 5, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Recurrent

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of utidelone capsule and capecitabine (two chemotherapy drugs) for women with metastatic (spread) or recurrent breast cancer that is HER2-negative and has stopped responding to standard treatments. **You may be eligible if...** - You are a woman between 18 and 70 years old - You have been diagnosed with HER2-negative metastatic or recurrent breast cancer, confirmed by biopsy - You are in reasonably good health (ECOG 0–1) with expected survival of at least 12 weeks - You have received prior standard treatments that are no longer working **You may NOT be eligible if...** - Your breast cancer is HER2-positive - You are male - You are outside the age range - Your health status does not meet the required criteria - You have not tried prior standard therapies Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGUtidelone 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 .