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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

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 (NCT06125080) is a Phase 2 interventional studying TNBC - Triple-Negative Breast Cancer, sponsored by Huihua Xiong. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against TNBC - Triple-Negative Breast Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 78 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused TNBC - Triple-Negative Breast Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: Patients voluntarily participated in the study, signed the willing to sign a consent form, and had good compliance; Female patients aged 18-70; TNBC confirmed by histology or cytology. Triple negative is defined as \<1% expression of estrogen receptor (ER) and progesterone receptor (PR), and negative in situ hybridization expression of human epidermal growth factor receptor 2 (HER2). Unresectable locally advanced or metastatic TNBC failed or relapsed after treatment with at least one line of standard chemotherapy regimens (taxanes and/or anthracyclines); Patients should have at least one measurable lesion (RECIST 1.1); ECOG PS 0 or 1; Expected survival ≥12 weeks; Blood test (without blood transfusion within 14 days) 1. Neutrophil absolute value ≥1.5×109/L, platelet count at least 100×109/L, hemoglobin concentration ≥9g/dL); 2. 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); 3. Renal function (serum creatinine ≤1.5×ULN, or creatinine clearance (CCr)≥60ml/min); 4. Coagulation, International standardized ratio (INR) ≤1.5, prothrombin time (PT) and activated partial thrombin time (APTT) ≤1.5×ULN; 5. Thyroid function, thyroid stimulating hormone (TSH) ≤ upper limit of normal (ULN); If abnormal, FT3 and FT4 levels should be examined, and normal FT3 and FT4 levels can be included. Women of reproductive age must undergo a negative serum pregnancy test within 14 days prior to treatment and be willing to use medically approved effective birth control (e.g., intrauterine devices, contraceptives or condoms) during the study period and within 3 months after the last study drug use. Who Should NOT Join This Trial: During the first 4 weeks of treatment, receive the following treatments: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: Patients voluntarily participated in the study, signed the informed consent, and had good compliance; Female patients aged 18-70; TNBC confirmed by histology or cytology. Triple negative is defined as \<1% expression of estrogen receptor (ER) and progesterone receptor (PR), and negative in situ hybridization expression of human epidermal growth factor receptor 2 (HER2). Unresectable locally advanced or metastatic TNBC failed or relapsed after treatment with at least one line of standard chemotherapy regimens (taxanes and/or anthracyclines); Patients should have at least one measurable lesion (RECIST 1.1); ECOG PS 0 or 1; Expected survival ≥12 weeks; Blood test (without blood transfusion within 14 days) 1. Neutrophil absolute value ≥1.5×109/L, platelet ≥100×109/L, hemoglobin concentration ≥9g/dL); 2. 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); 3. Renal function (serum creatinine ≤1.5×ULN, or creatinine clearance (CCr)≥60ml/min); 4. Coagulation, International standardized ratio (INR) ≤1.5, prothrombin time (PT) and activated partial thrombin time (APTT) ≤1.5×ULN; 5. Thyroid function, thyroid stimulating hormone (TSH) ≤ upper limit of normal (ULN); If abnormal, FT3 and FT4 levels should be examined, and normal FT3 and FT4 levels can be included. Women of reproductive age must undergo a negative serum pregnancy test within 14 days prior to treatment and be willing to use medically approved effective birth control (e.g., intrauterine devices, contraceptives or condoms) during the study period and within 3 months after the last study drug use. Exclusion Criteria: During the first 4 weeks of treatment, receive the following treatments: including but not limited to surgery, chemotherapy, radical radiotherapy, biotargeted therapy, immunotherapy, and other investigational drugs; Previous treatment with anti-VEGF /VEGFR targeting drugs, such as Bevacizumab; Or have previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or synergistic inhibition of T cell receptors in response to another stimulus (including but not limited to CTLA-4, OX-40, LAG-3, CD137, etc.); Immunosuppressive drugs have been administered in the 14 days prior to initiation of treatment, but do not include nasal and inhaled corticosteroid hormones or physiological doses of systemic steroid hormones (i.e., the daily dose of prednisolone does not exceed 10 mg or the equivalent physiological dose of another corticosteroid); History of any active autoimmune disease or autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; Subjects with vitiligo or asthma may have complete remission in childhood and do not currently require medical intervention, or have a history of allotransplantation or allohematopoietic stem cell transplantation); Have high blood pressure that is not well controlled by antihypertensive medications (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg) Urine routine indicated urine protein ≥2+, and 24 hours urine protein quantity \>1.0g; Obvious clinical bleeding symptoms or obvious bleeding tendency (bleeding \> 30 mL within 3 months, hematemesis, black feces, blood in stool), hemoptysis (fresh blood \> 5 mL within 4 weeks) within 3 months prior to treatment. Or treatment of venous/venous thrombosis events occurring within the preceding 6 months, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism; Long-term anticoagulant therapy with warfarin or heparin, or long-term antiplatelet therapy (aspirin ≥300 mg/day or clopidogrel ≥75 mg/day) is required; Active heart disease, including myocardial infarction, severe/unstable angina, occurs 6 months before treatment. Left ventricular ejection fraction \< 50% by echocardiography and poor arrhythmia control (including QTcF interval,\> 470 ms in women); The patient has had other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix) within the previous 3 years or at the same time. Known allergy to the study drug or any of its excipients, or severe allergic reaction to other monoclonal antibodies; Active or uncontrolled severe infection; 1. Known human immunodeficiency virus (HIV) infection; 2. A known history of clinically significant liver disease, including viral hepatitis \[active HBV infection, i.e., HBV DNA positive (\>1×104 copies /mL or \>2000 IU/ml) must be excluded for a known hepatitis B virus (HBV) carrier; 3. Known hepatitis C virus infection (HCV) and HCV RNA positive (\>1×103 copies /mL), or other hepatitis, cirrhosis\]; Any other medical condition, clinically significant metabolic abnormality, physical abnormality or laboratory abnormality, which, in the investigator's judgment, the patient has a medical condition or condition that is reasonably suspected to be unsuitable for the use of the study drug (such as the presence of epileptic seizures requiring treatment), or which would interfere with the interpretation of the study results, or place the patient at high risk; The patients considered by the investigators to be unsuitable for inclusion in this study.

Treatments Being Tested

DRUG

Utidelone

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

DRUG

Tirelizumab

Tirelizumab(200mg, day1, every 3 weeks)

DRUG

Bevacizumab

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

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Tongji Hospital Affiliated of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06125080), the sponsor (Huihua Xiong), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06125080 clinical trial studying?

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). The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06125080?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06125080?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06125080. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06125080. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.