breast cancer
Conditions
Interventions
Experimental group:Tislelizumab combined with chemotherapy
Sponsors
Army Medical Center of PLA
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1: Sign a written informed consent form before implementing any trial-related procedures; 2: Age: 18-70 years old, female; 3: Diagnosed with primary invasive triple-negative breast cancer (ER-, PR-, HER2(IHC) 0 or 1+ or 2+ but (FISH) negative); 4: Based on the AJCC breast cancer TNM staging, previously untreated non-metastatic (M0) TNBC: T1c, N1-2 or T2-4 N0-2; 5: ECOG 0-1 6: Major organ function meets the following criteria within 7 days before treatment: Routine blood test standards (without blood transfusion within 14 days): a. Hemoglobin (HB) =9g/dL b. Absolute neutrophil count (ANC) =1.5×10^9/L; c. Platelets (PLT) =100×10^9/L; Biochemical tests must meet the following criteria: a. Total bilirubin (TBIL) =1.5 times the upper limit of normal (ULN); or total bilirubin>ULN but direct bilirubin=ULN b. Alanine aminotransferase (ALT) and aspartate aminotransferase AST =2.5×ULN; c. Serum creatinine (Cr) =1.5×ULN or creatinine clearance (CCr) =60ml/min; 7: For child-bearing period female, a urine or serum pregnancy test should be performed within 3 days before the first administration of the research drug (day 1 of cycle 1) and the result should be negative. If the urinary pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Non-reproductive age women are defined as being postmenopausal for at least one year, or having undergone surgical sterilization or hysterectomy; 8: if there is a risk of pregnancy, all participants must use contraception with an annual failure rate of less than 1% throughout the treatment period and until 120 days after the last administration of the research drug (or 180 days after the last administration of the chemotherapy drug). 4.2 Exclusion Criteria for Participants
Exclusion criteria
Exclusion criteria: 1: Accompanied by other tumor diseases or diagnosed with other malignant diseases within 2 years before enrollment; except for those who have undergone radical treatment for basal cell or squamous cell skin cancer, cervical or breast carcinoma in situ 2: Received chemotherapy, radiotherapy, and targeted therapy in the past 12 months; 3: Have participated in clinical research related to immune therapy drugs such as anti-PD1, PDL1, or CTLA-4 antibodies; 4: Known to be allergic to the active ingredients or adjuvants of the study drugs, Tislelizumab, nab-paclitaxel, cyclophosphamide, or anthracyclines; 5: Currently receiving or planning to receive human papillomavirus (HPV) vaccination during the study period, or patients who have completed the last vaccination injection less than 6 months ago; 6: Patients with any severe and/or uncontrollable disease, including a) Patients with poor blood pressure control (systolic blood pressure =150 mmHg, diastolic blood pressure =100 mmHg); b) Suffering from grade I or above myocardial ischemia or myocardial infarction, arrhythmia (including QTc=480ms) and =grade 2 congestive heart failure (New York Heart Association (NYHA) grading); c) Active or uncontrollable severe infection; d) Cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis requiring antiviral treatment; e) Renal failure requiring hemodialysis or peritoneal dialysis; f) History of immune deficiency, including HIV positive or other acquired, congenital immune deficiency diseases, or history of organ transplantation; g) Poorly controlled diabetes (fasting blood glucose (FBG) >10 mmol/L); h) Urinalysis indicates proteinuria=++, and confirmed 24-hour proteinuria quantification>1.0g; i) Patients with epilepsy and need treatment; 7: the tumor has invaded important blood vessels or the researcher judges that the tumor is very likely to invade important blood vessels and cause fatal massive hemorrhage in the subsequent research period; 8: had an arterial/venous thromboembolic event, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, and pulmonary embolism in the past 6 months; 9: History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess in the past 6 months; 10: Participants with any signs or history of hemorrhagic diathesis, regardless of severity; participants who have had any bleeding or hemorrhagic event = CTC AE 3 level within 4 weeks before the first dose; or participants with unhealed wounds, fractures, active ulcers in the stomach and duodenum, ulcerative colitis and other gastrointestinal diseases, or unresected tumors with active bleeding, or other conditions that the researcher determines may cause gastrointestinal bleeding, perforation; 11: Uncontrollable recurrent drainage of pleural effusion, pericardial effusion or ascites; 12: Participated in other clinical trials within four weeks; 13: According to the researcher's judgment, there are severe diseases that endanger the safety of patients or affect the completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| event-free survival;Overall Survival; | — |
Countries
China
Contacts
Public ContactYan Xu
Army Medical Center of PLA
Outcome results
None listed