Abstract 26TiP
Background
Chemo-based immunotherapy improves the prognosis of TNBC. However, the dominant population and optimal chemo-backbone of neoadjuvant immunotherapy remain undefined. Taxane, adriamycin and cyclophosphamide (TAC) chemotherapy is the recommendation for TNBC neoadjuvant therapy, The aim of our trial was to assess the efficacy and safety of tislelizumab in combination with nab-P, adriamycin and cyclophosphamide in neoadjuvant therapy of TNBC.
Trial design
This is a prospective, single-arm, open-label, phase II trial. Eligible patients (pts) were women, aged 18-70 years, Eastern Cooperative Oncology Group (ECOG) status 0-1, previously untreated invasive TNBC with histologically confirmed (cT1cN1-2M0 or T2-4N0-2M0). 36 pts will be enrolled and received 6 cycles of tislelizumab (200 mg, once every 3 weeks) plus nab-paclitaxel (260 mg/m2, once every 3 weeks),anthracycline (epirubicin 75 mg/m2 or doxorubicin 60 mg/m2 or Pirarubicin 50 mg/m2) and cyclophosphamide 500mg/m2, followed by surgery. Tumor samples will undergo PD-L1 testing. The primary endpoint is pathological complete response rate (pCR, ypT0/Tis ypN0),and the secondary endpoints include pathological complete response rate (pCR, ypT0 ypN0), event-free survival (EFS), overall survival (OS), and safety. A sample size of 36 patients was estimated to provide 80% power to detect a difference of 22% in pCR at a two-sided significance level of α=0.05. ctDNA was analyzed in plasma collected at pretreatment, two cycles after treatment initiation and before surgery. The study was initiated in June 2024.
Clinical trial identification
ChiCTR2400084419.
Legal entity responsible for the study
The authors.
Funding
BeiGene and Jiatai Tianqing Pharmaceutical Group Co., Ltd.
Disclosure
All authors have declared no conflicts of interest.