Triple Negative Breast Cancer (TNBC)
Conditions
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Volunteer to join this study and sign the informed consent form; 2.Female patients with newly diagnosed breast cancer aged >= 18 and = 1.5 × 10^9/L; Platelets >= 100 × 10^9/L; Hemoglobin >= 90 g/L; Serum albumin >= 30 g/L; Thyroid-stimulating hormone (TSH) <= 1 × ULN (if abnormal, FT3 and FT4 levels should be evaluated; if FT3 and FT4 levels are normal, the patient may be enrolled); Total bilirubin <= 1.5 × ULN; ALT and AST <= 2.5 × ULN (if liver metastases are present, ALT and AST <= 5 × ULN); Alkaline phosphatase (AKP) <= 2.5 × ULN; Serum creatinine <= 1.5 × ULN; International normalized ratio (INR) <= 1.5 (for patients not receiving anticoagulation therapy). 8.Non-surgically sterilized or female patients of childbearing age must use a medically approved contraceptive method (such as an intrauterine device, contraceptive pills, or condoms) during the study treatment period and for 3 months after the end of the study treatment period; non-surgically sterilized female patients of childbearing age must have a negative serum or urine HCG test within 7 days before the first dose; and must not be breastfeeding; for male patients with partners of childbearing age, effective contraception should be used during the trial and for 3 months after the last administration of the trial drug;
Exclusion criteria
Exclusion criteria: 1.Presence of any active autoimmune disease or history of autoimmune disease (such as, but not limited to, autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism; patients with vitiligo or childhood asthma that has completely resolved and requires no intervention in adulthood are eligible; asthma requiring bronchodilator intervention is not eligible); 2.Currently using immunosuppressants, or systemic corticosteroid therapy for immunosuppressive purposes (dose >10mg/day prednisone or other equivalent corticosteroids), and continued use within 2 weeks prior to enrollment; 3.History of severe allergic reaction to other monoclonal antibodies; 4.Known history or evidence of interstitial lung disease or active non - infectious pneumonia; 5.Known central nervous system metastasis; 6.History of other malignant tumors within the past 5 years or concurrent with the study (except for cured basal cell carcinoma of the skin and cervical carcinoma in situ); 7.Hypertension that cannot be well - controlled with antihypertensive medication (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg); allowed to achieve the above parameters through the use of antihypertensive treatment; history of hypertensive crisis or hypertensive encephalopathy; 8.Uncontrolled cardiac symptoms or diseases, such as: (1) NYHA class 2 or higher heart failure (2) Unstable angina (3) Myocardial infarction within 1 year (4) Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention (5) QTc >450ms (male); QTc >470ms (female); 9.Currently receiving thrombolytic or anticoagulant therapy; allowed to use low - dose aspirin and low - molecular - weight heparin prophylactically; 10.Significant clinically significant bleeding symptoms within 3 months prior to enrollment or a clear tendency to bleed; if fecal occult blood is positive at baseline, a re - examination can be performed; if still positive after re - examination, a gastroscopy is required; 11.Tumor invasion of major blood vessels, or the researcher judges based on imaging that there is a high possibility of tumor invasion of major blood vessels during the study period, which may lead to fatal bleeding; 12.Patients with pleural effusion, ascites, or pericardial effusion requiring drainage, if the symptoms are stable after drainage as assessed by the researcher, enrollment is allowed; 13.Arterial/venous thrombotic events within 6 months prior to enrollment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism, etc.; 14.Known hereditary or acquired bleeding and thrombotic tendencies (such as hemophiliacs, coagulation disorders, etc.); 15.Major vascular disease within 6 months prior to the start of study treatment (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis); 16.Urinalysis indicating proteinuria >= ++ and confirmed 24 - hour urine protein >1.0 g; 17.Active infection, unexplained fever >= 38.5°C within 7 days prior to medication, or baseline white blood cell count >15×10^9/L; 18.Congenital or acquired immune function deficiency (such as HIV - infected individuals); positive hepatitis B surface antigen (HBsAg) and hepatitis B virus deoxyribonucleic acid (HBV DNA) >= 2000 IU/ml, or positive hepatitis C virus antibody; 19.Live vaccine administere
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| tPCR: ypT0/is N0; | — |
Secondary
| Measure | Time frame |
|---|---|
| pCR in breast cancer (tPCR: ypT0/is ypN0);AE?SAE?TRAEs;Proportion of residual cancer burden (RCB) 0-1;Objective response rate, ORR; | — |
Countries
China
Contacts
Public ContactWang Hao
Sichuan Cancer Hospital
Outcome results
None listed