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
Study ID
NCT06125080
Phase
PHASE2
Status
Recruiting
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Conditions

  • TNBC - Triple-Negative Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Utidelone — DRUG
    Utidelone (30 mg/m2, days 1-5, every 3 weeks)
  • Tirelizumab — DRUG
    Tirelizumab（200mg, day1, every 3 weeks）
  • Bevacizumab — DRUG
    Bevacizumab(7.5mg/kg, day1, every 3 weeks)

Study Details

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).

Key Dates

First listed
Nov 9, 2023
Start date
Oct 30, 2023
Status verified
Nov 2023
Primary completion
Oct 30, 2025
Completion
Oct 30, 2026

Study Design

Enrollment
78 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Utidelone+Tirelizumab+Bevacizumab

Primary Outcome Measure

Objective Response Rate, ORR [ Time Frame: approximately 1 years ]

Central Contacts

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