OncoMatch/Clinical Trials/NCT06125080
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
Is NCT06125080 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Utidelone and Tirelizumab for tnbc - triple-negative breast cancer.
Treatment: Utidelone · Tirelizumab · Bevacizumab — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression <1% (<1%)
<1% expression of estrogen receptor (ER)
Required: PR (PGR) expression <1% (<1%)
<1% expression of progesterone receptor (PR)
Required: HER2 (ERBB2) negative in situ hybridization expression (negative)
negative in situ hybridization expression of human epidermal growth factor receptor 2 (HER2)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: chemotherapy (taxane, anthracycline)
failed or relapsed after treatment with at least one line of standard chemotherapy regimens (taxanes and/or anthracyclines)
Cannot have received: anti-VEGF/VEGFR targeting drugs (bevacizumab)
Previous treatment with anti-VEGF /VEGFR targeting drugs, such as Bevacizumab
Cannot have received: anti-PD-1 therapy
previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs
Cannot have received: checkpoint inhibitor
synergistic inhibition of T cell receptors in response to another stimulus (including but not limited to CTLA-4, OX-40, LAG-3, CD137, etc.)
Lab requirements
Blood counts
Neutrophil absolute value ≥1.5×10^9/L, platelet ≥100×10^9/L, hemoglobin concentration ≥9g/dL
Kidney function
serum creatinine ≤1.5×ULN, or creatinine clearance (CCr)≥60ml/min
Liver function
aspartate aminotransferase and glutamic aminotransferase ≤2.5×ULN, bilirubin ≤1.5×ULN; In the presence of liver metastasis, AST and ALT≤5×ULN
Cardiac function
Left ventricular ejection fraction < 50% by echocardiography and poor arrhythmia control (including QTcF interval, > 470 ms in women)
Blood test (without blood transfusion within 14 days): Neutrophil absolute value ≥1.5×10^9/L, platelet ≥100×10^9/L, hemoglobin concentration ≥9g/dL; Liver function test (aspartate aminotransferase and glutamic aminotransferase ≤2.5×ULN, bilirubin ≤1.5×ULN; In the presence of liver metastasis, AST and ALT≤5×ULN); Renal function (serum creatinine ≤1.5×ULN, or creatinine clearance (CCr)≥60ml/min); Left ventricular ejection fraction < 50% by echocardiography and poor arrhythmia control (including QTcF interval, > 470 ms in women)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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