RecruitingPhase 2NCT06125080

The Efficacy and Safety of Utidelone Plus Tirelizumab and Bevacizumab for Advanced or Metastatic Triple-negative Breast Cancer (UTILIZABLE) :Single-arm, Prospective, Open Clinical Study


Sponsor

Huihua Xiong

Enrollment

78 participants

Start Date

Oct 30, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multicenter, open-label, single-arm clinical study designed to evaluate the safety and efficacy of Utidelone plus Tirelizumab and Bevacizumab for advanced or metastatic triple-negative breast cancer (TNBC).


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying a three-drug combination — Utidelone (a chemotherapy), Tirelizumab (an immunotherapy), and Bevacizumab (a drug that cuts off tumor blood supply) — for women with advanced triple-negative breast cancer that has already been treated with standard chemotherapy. **You may be eligible if:** - You are a woman aged 18–70 - You have triple-negative breast cancer (ER negative, PR negative, HER2 negative) confirmed by biopsy - Your cancer is locally advanced or has spread, and has failed or relapsed after at least one chemotherapy regimen - You have at least one measurable tumor - You have good physical functioning (ECOG score 0–1) - Your blood counts, liver, kidney, and thyroid function are within acceptable ranges **You may NOT be eligible if:** - You have had prior anti-VEGF therapy (like Bevacizumab) or prior PD-1/PD-L1 immunotherapy - You have active autoimmune disease - You have uncontrolled high blood pressure - You have had a stroke, blood clot, or heart attack within the past 6 months - You have active HIV, hepatitis B, or hepatitis C - You are pregnant or breastfeeding 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

Utidelone (30 mg/m2, days 1-5, every 3 weeks)

DRUGTirelizumab

Tirelizumab(200mg, day1, every 3 weeks)

DRUGBevacizumab

Bevacizumab(7.5mg/kg, day1, every 3 weeks)


Locations(1)

Tongji Hospital Affiliated of Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06125080


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