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Tests treatment safety and results for TNBC - Triple-Negative Breast Cancer
Official title 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
ClinicalTrials.gov ID: NCT06125080
What this study is testing
What is Utidelone?
Utidelone is an investigational medicine, being studied as a potential treatment for tnbc - triple-negative breast cancer.
Also referred to as UTD1.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70, women only
You may be able to join if
- Patients voluntarily participated in the study, signed the informed consent, and had good compliance; Female patients aged 18-70; TNBC confirmed by...
- Neutrophil absolute value ≥1.5×109/L, platelet ≥100×109/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...
- Renal function (serum creatinine ≤1.5×ULN, or creatinine clearance (CCr)≥60ml/min);
- Coagulation, International standardized ratio (INR) ≤1.5, prothrombin time (PT) and activated partial thrombin time (APTT) ≤1.5×ULN;
You likely can't join if
- During the first 4 weeks of treatment, receive the following treatments: including but not limited to surgery, chemotherapy, radical radiotherapy...
- Known human immunodeficiency virus (HIV) infection;
- A known history of clinically significant liver disease, including viral hepatitis [active HBV infection, i.e., HBV DNA positive (\>1×104 copies /mL...
- Known hepatitis C virus infection (HCV) and HCV RNA positive (\>1×103 copies /mL), or other hepatitis, cirrhosis]; Any other medical condition...
See the full eligibility 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...
- Neutrophil absolute value ≥1.5×109/L, platelet ≥100×109/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);
- Coagulation, International standardized ratio (INR) ≤1.5, prothrombin time (PT) and activated partial thrombin time (APTT) ≤1.5×ULN;
- 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...
- 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...
- Known human immunodeficiency virus (HIV) infection;
- 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)...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.