Neoadjuvant Toripalimab Plus Docetaxel and Carboplatin in Patients With Localized TNBC (NeoTOP)

Exclusion Criteria

• •Inflammatory breast cancer or stage IV breast cancer.
• •Prior systemic antitumor treatment for any malignancy, including chemotherapy, radiotherapy, immunotherapy and targeted therapy.
• •History of another malignancy in the last 5 years with the exception of the following: other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted. Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted.
• •Inability to comply with protocol or study procedures.
• •Subjects with active, known or suspected autoimmune disease. Subjects in conditions not expected to recur in the absence of an external trigger, or not requiring systemic treatment are permitted to enroll.
• •Previous history of interstitial lung disease/pneumonia.
• •Patient who has had an allogeneic tissue/solid organ transplant.
• •A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
• •A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease.
• •Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
• •Patient who has active serious infection (e.g. pyrexia of or 38.0℃ over)
• •Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
• •Women who are pregnant or nursing.