drugset / Trial / NCT06500208

Neoadjuvant Adebrelimab and Chemotherapy in High-rish ER+/HER2- BC

NCT06500208

Phase 2 Recruiting 48 enrolled Shanghai Jiao Tong University School of Medicine
NaSingle-groupOpen-labelTreatment

Summary

Investigators plan to conduct a single-arm clinical study of adebelimab, a novel PD-L1 inhibitor, in the neoadjuvant treatment of early or locally advanced high-risk ER+/HER2- breast cancer, to explore whether the addition of immune checkpoint inhibitors to traditional neoadjuvant chemotherapy can improve the pathologic complete response rate (pCR) of patients, evaluate its therapeutic safety, and further analyze the biomarkers of the efficacy of neoadjuvant immunotherapy for ER+/HER2- breast cancer, so as to support the clinical application of the drug.

Timeline

Start
2024-11-01
Primary completion
2025-12-31
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Adebrelimab Monoclonal antibody 1200 mg Intravenous
Subject Cyclophosphamide Other / unclassified 600 mg/m2
Subject Epirubicin Small molecule 90 mg/m2
Subject Paclitaxel Small molecule 100 mg/m2

Indications