Neoadjuvant Chemotherapy Combined With Sintilimab and Bevacizumab for Triple Negative Breast Cancer:A Prospective, Single-Arm, Multicenter Clinical Study (NEOTORCII-BREASTO7)
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 treatment of TNBC breast cancer with neoadjuvant chemotherapy combined with Sintilimab and Bevacizumab , including the incidences and types of adverse events. The secondary study objective is to observe and evaluate the event-free survival (EFS), Objective Response Rate(ORR), and radiologic complete response (rCR).
• Female patients aged 18-70 years old;
• ECOG score is 0-1 points;
• Histologically confirmed stage II-III (T1N1-3; T2-4N0-2) invasive breast cancer;
• ER-negative, PR-negative, and HER2 receptor-negative. Alternatively, if ER and PR expression is less than 10% and HER2 receptor is negative, it is also classified as TNBC;
• 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.