NCT06500208

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

An Open-label, One-arm Phase II Study of Adebrelimab Combined With Neoadjuvant Chemotherapy for High-risk, Early-stage and Locally Advanced Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Adebrelimab combined with nab-paclitaxel, epirubicin and cyclophosphamide	Adebrelimab 1200mg i.v. q3w combined with nab-paclitaxel 100mg/m2 qw\*12w followed by epirubicin 90mg/m2 and cyclophosphamide 600mg/m2 q3w for 4 cycles

Timeline

• Start date: 2024-11-01
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2024-07-15
• Last updated: 2025-06-26

Locations

1 site across 1 country: China