The Efficacy and Safety of Sintilimab Plus Anlotinib Combined With Chemotherapy as Neoadjuvant Therapy in TNBC
Status:
Recruiting
Trial end date:
2024-12-31
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate the efficacy and safety of Sintilimab plus anlotinib
combined with chemotherapy as neoadjuvant therapy in participants who have triple negative
breast cancer (TNBC). After a screening phase of approximately 28 days, each participant will
receive neoadjuvant study treatment (Sintilimab + anlotinib + chemotherapy) based on schedule
for approximately 24 weeks (8 cycles). Each participant will then undergo definitive surgery
4-6 weeks after conclusion of the last cycle of the neoadjuvant study treatment. Following
adjuvant study treatment, each participant will be monitored for safety, survival and disease
recurrence. The primary outcome measure is pathological complete response (pCR) rate using
the definition of ypT0/Tis ypN0.