Neoadjuvant Chemotherapy Combined With Toripalimab for Triple-negative Breast Cancer : a Prospective, Single-arm, Multi-center Study (NEOTORCH-BREAST02)
This study is a prospective, single arm, multi-center phase II clinical trial. The primary study objective is to evaluate the pathologic complete response（PCR） of Adjuvant treatment of TNBC breast cancer with Toripalimab combined with neoadjuvant chemotherapy, including the incidences and types of adverse events. The secondary study objective is to observe and evaluate the disease-free survival (DFS), Progression-Free-Survival (PFS ),and Objective Response Rate(ORR)
• Female patients aged 18-70 years old;
• ECOG score is 0-1 points;
• Histologically proven tumors \>1cm in diameter (T1c-3; N0-2; M0) invasive breast cancer;
• All patients had triple negative breast cancer confirmed by histopathology;
• Pathological examination of PD-L1 expression:
• The Combined Positive Score (CPS) refers to the percentage of PD-L1 positive cells (including tumor cells, lymphocytes, macrophages) in all tumor cells. Our center detected the PD-L1 antibody site as 22C3.
• The functional level of major organs must meet requirements
• For female patients who have not yet reached menopause or undergone surgical sterilization: during the treatment period and in the study treatment, the final use effective contraceptive methods for at least 6 months after a single administration.
• Voluntarily join this study, sign an informed consent form, have good compliance, and are willing to cooperate with follow-up.