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;
Stage IV breast cancer.
Inflammatory breast cancer.
Previously received anti-tumor treatment or radiation therapy for any malignant tumor, excluding those that have been cured Malignant tumors such as cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma.
Simultaneously undergoing anti-tumor treatment in other clinical trials, including but not limited to chemotherapy and endocrine therapy. Treatment, biological therapy, bone improvement drug therapy, or immune checkpoint inhibitor therapy, etc.
Single group
Neoadjuvant chemotherapy combined with Sintilimab and Bevacizumab
Drug1, Neoadjuvant Chemotherapy Phase Combined with Sintilimab and Bevacizuma, Administered intravenously: carboplatin (AUC=5), nab-paclitaxel (260 mg/m²) + 200 mg Sintilimab + Bevacizumab (7.5 mg/kg), every 3 weeks for a total of 12 weeks. 2, Receive Breast Cancer Definitive Surgery After 4 Cycles of Neoadjuvant Chemotherapy 3, Postoperative Adjuvant Therapy 1)If pathology indicates pCR: Continue immunotherapy, administering 200 mg Sintilimab intravenously every 3 weeks for a total of 1 year. 2)If pathology indicates non-PCR: Continue 4 cycles of postoperative adjuvant chemotherapy (100 mg/m² Epirubicin + 600 mg/m² Cyclophosphamide) combined with 200 mg Sintilimab intravenously every 3 weeks for a total of 1 year. 4, Perform Gene Testing on Biopsy Tissue Before Treatment, and Collect Blood Samples for ctDNA Testing Before and After Treatment.
pathologic complete response（PCR）
Event free survival (EFS)
objective response rate (ORR)
radiologic complete response (rCR)
Click on the lead sponsor to view all of their trials.
