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 (Jun 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
Treatments studied
Targeted therapy
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06125080 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-VEGF/VEGFR targeting drugs, anti-PD-1 therapy, checkpoint inhibitor disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 expression <1% is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR expression <1% is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative in situ hybridization expression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 70 years or younger.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify