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

Prior treatment

• Prior systemic antitumor treatment for any malignancy, including chemotherapy, radiotherapy, immunotherapy and targeted therapy.
• 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.
• 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).

Other illness

• Inflammatory breast cancer or stage IV breast cancer.
• 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.
• 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.
• A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart 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).

Other

• Inability to comply with protocol or study procedures.
• Women who are pregnant or nursing.

• Pathologically confirmed TNBC. ER and PR negatives are defined as \< 10% of cells expressing hormone receptors by IHC analysis. HER2 negative is defined as IHC 0 or 1+, or ISH-negative.
• Treatment-naive clinical stage T1-4N1-N3 or T2-4N0 localized TNBC.
• Female patients aged ≥18 years, \< 70 years.
• Able to comply with the required protocol and follow-up procedures.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Life expectancy ≥12 weeks.
• Adequate hematological function: Absolute neutrophil count (ANC) ≥1.5 x 109/L, and Platelet count ≥90 x 109/L, and Hemoglobin ≥90 g/L (may be transfused to maintain or exceed this level).
• Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 1.5 x ULN.
• Adequate renal function: Serum creatinine ≤ 1.5 x ULN, and creatinine clearance ≥ 50 ml/min.
• Subjects should not be pregnant or breast-feeding.