Trial Title:
Surufatinib Combined With Tislelizumab in the Second-line and Further Treatment of Triple-negative Breast Cancer
NCT ID:
NCT05746728
Condition:
Metastatic Triple-negative Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Tislelizumab
Conditions: Keywords:
Surufatinib plus Tislelizumab
TNBC
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Surufatinib
Description:
Safety run-in phase: 200-250mg, QD, Q3W
Dose expansion phase: according to the dose determined in the safety run-in phase
Arm group label:
surufatinib + tislelizumab
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
200mg, d1, iv, Q3W
Arm group label:
surufatinib + tislelizumab
Summary:
This is a multicenter, open-label, single-arm clinical study designed to evaluate the
safety and efficacy of surufatinib combined with tislelizumab in the treatment of
metastatic triple-negative breast cancer (TNBC). The study will be conducted in two
parts; Safety lead-in phase and dose expansion phase.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients voluntarily participated in the study, signed the informed consent, and had
good compliance;
- Female patients ≥18 years;
- 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). For patients with documented germ line BRCA1/BRCA2 (breast cancer 1
gene/breast cancer 2 gene) mutations, PARP inhibitors can be considered as one of
the previous standard therapies if they have been treated with approved PARP
inhibitors;
- 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 Surufatinib; 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);
- Symptomatic brain or meningeal metastases (except those with brain metastases that
have undergone local radiotherapy or surgery for more than 6 months and whose
disease control is stable);
- Severe infection (e.g. intravenous antibiotic, antifungal, or antiviral) within 4
weeks of treatment, or unexplained fever > 38.5 ℃ during screening/initial
administration;
- 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, > 450 ms in
men and > 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:
All
Minimum age:
18 Years
Maximum age:
N/A
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
Contact:
Last name:
Huihua Xiong, PI
Phone:
02783663405
Email:
xionghuihua@hotmail.com
Start date:
April 2023
Completion date:
August 2025
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/NCT05746728
