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female participants aged 18 years and < 75 years |
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Participants with a histological or cytological diagnosis of TNBC breast cancer , defined by ER <1%, PR <1% and HER2 negative on IHC and/or non-amplified by ISH by local lab testing |
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Gene detection for Subtypes of TNBCPD-L1expression and TMB expression |
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Breast-conserving therapy is planned after mastectomy 1) largest focus must measure of Primary tumor 5cmTumor invades breast skin and chest wall 2) Axillary lymph node metastasis4 3) 1 -3 lymph node metastases in stage T1-2 4) Simple mastectomy combined with axillary lymphadenectomy in stage T1-2 (axillary lymph nodes are positive, and subsequent axillary dissection is not considered) |
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Adequate Organ Function as defined in the table below |
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Absolute neutrophil count (ANC) 1500/uL Platelet count 100,000/uL Hemoglobin |
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6mmol/L9.0g/dL) serum albumin 2.8g/dL Serum creatinine 1.5mg/d or creatinine |
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clearance 50mL/min Serum Total Bilirubin 1.5 X ULN AST&ALT2.5ULN |
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\. 12 lead ECG: friderica corrected QT interval (QTCF) < 470 Ms |
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\. Women of childbearing potential must have a negative urine or serum |
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pregnancy test within 28 day prior to registration; women/men of reproductive |
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potential must have agreed to use an effective contraceptive method for the |
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course of the study through 90 days after the last dose of study medication |
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\. Written informed consent obtained from subject and ability for subject to |
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comply with the requirements of the study |
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Known additional malignancy that is progressing or has required active treatment
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Note: Participants with basal cell carcinoma of the skin, squamous cell
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carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical
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cancer in situ) that have undergone potentially curative therapy are not
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excluded
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\. Patients with evident metastatic lesions at the time of diagnosis
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\. Has received prior therapy with an anti-PD-1, anti-PD-L1.History of severe
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allergic, anaphylactic, or other hypersensitivity reactions to chimeric or
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humanized antibodies or fusion proteins
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\. There are any active autoimmune diseases or a medical history of
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autoimmune (including, but not limited to: autoimmune hepatitis, interstitial
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pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis
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nephritis, hyperthyroidism, thyroid function Decreased. Subjects with vitiligo
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or adults who have had childhood asthma but have fully relieved without any
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intervention may be included. However, subjects who require bronchodilators
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for medical intervention cannot be included.)
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\. Active autoimmune disease that has required systemic treatment in the past
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years (i.e. with use of disease modifying agents, corticosteroids or
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immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or
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physiologic corticosteroid replacement therapy for adrenal or pituitary
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insufficiency, etc.) is not considered a form of systemic treatment
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\. Ascites or pleural effusion with clinical symptoms, requiring therapeutic
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puncture or drainage
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\. Cardiac clinical symptoms or diseases that are not well controlled, such
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as: a. Heart Failure NYHA > Class , b. unstable angina, c. myocardial
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infarction within 1 year; d. Clinically significant supraventricular or
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ventricular arrhythmia requiring treatment or intervention
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\. Abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg<2g/L), with
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obvious bleeding tendency or undergoing thrombolytic or anticoagulant
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treatment
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\. History of clear tendency of gastrointestinal hemorrhage and active
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bleeding in unresected tumor within 3 months prior to the start of study
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treatment. for example, esophageal varices, gastric and duodenal active ulcer
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ulcerative colitis, portal hypertension ; Or other conditions that may cause
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gastrointestinal bleeding and perforation determined by the researchers
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\. Previous or current serious bleeding (bleeding > 30ml in 3 months)
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hemoptysis (fresh blood > 5ml in 4 weeks) or thromboembolism within 12 months
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(including stroke events and / or transient ischemic attacks)
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\. The patient has active infection during screening period, or unexplained
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fever (38.5 C) before first administration ( According to the judgment of the
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researcher, the fever caused by the tumor can be included in the group)
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\. Abdominal fistula, gastrointestinal perforation or intraperitoneal
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abscess within 4 weeks prior to the start of study treatment
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\. Has a history of idiopathic pulmonary fibrosis (including pneumonitis)
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drug-induced pneumonitis, organising pneumonia (i.e., bronchiolitis
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obliterans, cryptogenic organizing pneumonia), or evidence of active
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pneumonitis on screening chest CT scan
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\. Subjects with congenital or acquired immunodeficiency (such as HIV-
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infected), or active hepatitis (hepatitis B reference: HBsAg-positive, HBV DNA
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IU/ml or copy number 104/ml; hepatitis C reference: HCV antibody-
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positive.)
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\. Patients who are participating in other clinical trials or less than 1
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month from the end of the previous clinical study; Patients may receive other
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systemic anti-tumor treatment during the study period
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\. Receive live vaccine within 4 weeks before or during the study period
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\. Has known psychiatric or substance abuse disorders that would interfere
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with cooperation with the requirements of the trial
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\. According to the investigator's assessment, there are other factors that
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may lead to the termination of the study, such as other serious diseases
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(including mental illness) requiring combined treatment. Any other condition
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and social/psychological problems, etc., the investigator judged that the
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patient was not suitable for participation in the study
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