Breast Cancer
Conditions
Interventions
toripalimab
Sponsors
Jiangxi Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.The subjects voluntarily participated in this study, signed the informed consent form, and demonstrated good compliance; 2. Age: 18-75 years (at the time of signing the informed consent form); 3. ECOG PS score: 0~1; 4. Subjects with triple-negative invasive breast cancer confirmed by histopathology or cytology, HER2 immunohistochemistry 0-1+ or 2+ and negative for in situ hybridization (ISH); ER-negative and PR-negative: the proportion of tumor cells with positive staining among all tumor cells is =90 g/L (no blood transfusion or use of hematopoietic stimulating factor drugs for correction within 7 days before the test); (2) Absolute neutrophil count (NEUT) >=1.5×10^9/L (no blood transfusion or hematopoietic stimulant medication used within 7 days prior to the test for correction); (3) Platelet count (PLT) >= 100 × 10^9/L (no blood transfusion or correction with hematopoietic stimulating factor drugs within 7 days prior to the test). (4) Total bilirubin (TBIL) =60ml/min; (7) Serum albumin >= 30 g/L; Prothrombin time (PT) =50%. 9. Female subjects of childbearing age must agree to use contraception (such as intrauterine devices, oral contraceptives, or condoms) during the study and for 6 months after its completion; they must have a negative serum pregnancy test within 7 days prior to study enrollment and be non-lactating; male subjects must agree to use contraception during the study and for 6 months after its completion.
Exclusion criteria
Exclusion criteria: 1. Stage IV metastatic breast cancer, or other subjects deemed by researchers to be ineligible for curative resection through neoadjuvant therapy. 2. Bilateral breast cancer. 3. History of invasive breast cancer or ductal carcinoma in situ (excluding ductal carcinoma in situ treated only with mastectomy >5 years prior to the current diagnosis). 4. Any prior anti-tumor treatment for breast cancer, including chemotherapy, endocrine therapy, targeted therapy, radiotherapy, and surgical treatment (excluding ductal carcinoma in situ diagnosed by biopsy, where only mastectomy was performed more than 5 years before the current diagnosis). 5. Combined Diseases and Medical History (1) History of or concurrent presence of other malignant tumors within the past 5 years. The following two conditions qualify for enrollment: other malignant tumors treated with a single surgical procedure and achieving a disease-free survival (DFS) of 5 consecutive years; cured cervical in situ carcinoma, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumors), Tis (carcinoma in situ), and T1 (tumor invasion of the basement membrane)]; (2) Adverse reactions from prior treatments failed to recover to a CTCAEv5.0 grade 325 mg/day (maximum antiplatelet dose), or dipyridamole, ticlopidine, clopidogrel, and cilostazol within 7 days before the study treatment begins; (6) Patients who had experienced arterial/deep venous thrombotic events within 6 months prior to the first dose administration, such as cerebrovascular accidents (excluding transient ischemic attacks, cerebral hemorrhage, cerebral infarction, and asymptomatic, non-treatment-required lacunar infarction), deep vein thrombosis, and pulmonary embolism; those with implantable venous access ports or catheter-induced thrombosis were enrolled after thrombus resolution without requiring anticoagulation therapy; (7) Inadequate blood pressure control (systolic blood pressure >=150 mmHg or diastolic blood pressure >=100 mmHg); (8) Suffering from significant cardiovascular diseases, including any of the following conditions: ? Heart failure classified as NYHA Class II or higher; ? A history of clinically significant ventricular arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes) or arrhythmias requiring continuous antiarrhythmic medication; ? Unstable angina; ? Myocardial infarction occurring within the past 6 months; ? Corrected QT interval (QTcF) >450 milliseconds (msec) in males or >470 msec in females (if QTc is abnormal, three consecutive mea
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactZhengkui Sun
Jiangxi Cancer Hospital
Outcome results
None listed