The Efficacy and Safety of Sintilimab Plus Anlotinib Combined With Chemotherapy as Neoadjuvant Therapy in TNBC

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.

Timeline

Start

2021-09-15

Primary completion

2023-08-31

Completion

2026-03-10

Outcome

Met primary endpoint

paper The primary endpoint, pathological complete response (pCR), is achieved in 69.0% (95% confidence interval [CI]: 49.0%-85.0%) PMID 40541191 ↗

Publications

• Zhang L, Yang L, Ge Y, Zhu Z, Chen B, Yang C, Gao H, Yang M, Zhu T, Wang K. Neoadjuvant anlotinib/sintilimab plus chemotherapy in triple-negative breast cancer (NeoSACT): Phase 2 trial. Cell Rep Med. 2025 Jul 15;6(7):102193. doi: 10.1016/j.xcrm.2025.102193. Epub 2025 Jun 19.

Drugs

Indications