Trial 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
NCT ID:
NCT06125080
Condition:
TNBC - Triple-Negative Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Bevacizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Utidelone
Description:
Utidelone (30 mg/m2, days 1-5, every 3 weeks)
Arm group label:
Utidelone+Tirelizumab+Bevacizumab
Other name:
UTD1
Intervention type:
Drug
Intervention name:
Tirelizumab
Description:
Tirelizumab（200mg, day1, every 3 weeks）
Arm group label:
Utidelone+Tirelizumab+Bevacizumab
Intervention type:
Drug
Intervention name:
Bevacizumab
Description:
Bevacizumab(7.5mg/kg, day1, every 3 weeks)
Arm group label:
Utidelone+Tirelizumab+Bevacizumab
Summary:
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).
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tongji Hospital Affiliated of Tongji Medical College Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430000
Country:
China
Status:
Recruiting
Contact:
Last name:
Huihua Xiong, PI
Phone:
027-83663405
Email:
xionghuihua@hotmail.com
Investigator:
Last name:
Huihua Xiong, PI
Email:
Principal Investigator
Start date:
October 30, 2023
Completion date:
October 30, 2026
Lead sponsor:
Agency:
Huihua Xiong
Agency class:
Other
Source:
Tongji Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06125080
