Actively Recruiting
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
Led by Huihua Xiong · Updated on 2023-11-09
78
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 70 years
- Confirmed triple-negative breast cancer (TNBC) by histology or cytology
- TNBC defined as less than 1% estrogen receptor and progesterone receptor expression, and negative HER2
- Unresectable locally advanced or metastatic TNBC with failure or relapse after at least one line of standard chemotherapy (taxanes and/or anthracyclines)
- At least one measurable lesion according to RECIST 1.1 criteria
- ECOG performance status 0 or 1
- Expected survival of at least 12 weeks
- Blood counts within specified limits (neutrophils ≥1.5x10^9/L, platelets ≥100x10^9/L, hemoglobin ≥9 g/dL)
- Liver function tests within specified limits, with adjusted limits if liver metastasis present
- Renal function with serum creatinine ≤1.5xULN or creatinine clearance ≥60 ml/min
- Coagulation tests within specified limits (INR ≤1.5, PT and APTT ≤1.5xULN)
- Thyroid function with TSH within normal limits; if abnormal, normal FT3 and FT4 levels required
- Negative pregnancy test within 14 days before treatment for women of reproductive age
- Willingness to use effective birth control during the study and for 3 months after last study drug use
You will not qualify if you...
- Receiving surgery, chemotherapy, radical radiotherapy, biotargeted therapy, immunotherapy, or investigational drugs during the first 4 weeks of treatment
- Prior treatment with anti-VEGF/VEGFR drugs such as Bevacizumab
- Prior use of anti-PD-1, anti-PD-L1, anti-PD-L2, or other T cell receptor synergistic inhibitors
- Use of immunosuppressive drugs within 14 days before treatment, except nasal/inhaled corticosteroids or low-dose systemic steroids
- History of active autoimmune disease or autoimmune disease requiring treatment
- Uncontrolled high blood pressure (systolic ≥140 mmHg or diastolic ≥90 mmHg)
- Significant proteinuria (urine protein ≥2+ or 24-hour urine protein >1.0 g)
- Recent significant bleeding or thrombosis events within specified timeframes
- Long-term anticoagulant or antiplatelet therapy as specified
- Active heart disease within 6 months, low heart function (LVEF <50%), or poor arrhythmia control
- Other malignancies within past 3 years except certain skin and cervical cancers
- Known allergy to study drugs or severe allergic reactions to monoclonal antibodies
- Active or uncontrolled severe infections
- Known HIV infection
- Active hepatitis B or C infection exceeding viral load thresholds
- Any other medical or laboratory condition deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tongji Hospital Affiliated of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
Research Team
H
Huihua Xiong, PI
CONTACT
T
Tengfei Chao, Sub-I
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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