NCT06908668

Evaluate the Efficacy and Safety of Adebrelimab Combined With Chemotherapy With or Without Radiotherapy as Neoadjuvant Treatment for HER2-Negative Locally Advanced Breast Cancer

A Prospective, Multicenter, Randomized Controlled Phase II Study to Evaluate the Efficacy and Safety of Adebrelimab Combined With Chemotherapy With or Without Radiotherapy as Neoadjuvant Treatment for HER2-Negative Locally Advanced Breast Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

A Prospective, Multicenter, Randomized Controlled Phase II Study to Evaluate the Efficacy and Safety of Adebrelimab Combined with Chemotherapy with or without Radiotherapy as Neoadjuvant Treatment for HER2-Negative Locally Advanced Breast Cancer

Conditions

• HER2-Negative Locally Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	Neoadjuvant Chemotherapy Combined with Immunotherapy and Radiotherapy	1. Recommended Chemotherapy Regimen and Doses: Albumin-bound Paclitaxel 260 mg/m² on Day 1, every 3 weeks (Q3W) × 4 cycles, followed by Epirubicin 90 mg/m² on Day 1 + Cyclophosphamide 600 mg/m² on Day 1, every 3 weeks (Q3W) × 4 cycles. 2. Recommended Immunotherapy Dose: Adebrelimab 1200 mg, repeated every 3 weeks, starting simultaneously with neoadjuvant chemotherapy and continuing for 1 year (including postoperative administration). 3. Radiotherapy: Preoperative Radiotherapy: Positioning: Immobilization with a neck-chest integrated frame, combined CT and MRI positioning with image fusion. Diagnostic MRI images can also be fused simultaneously. CT positioning should be performed with a plain scan, with a slice thickness of 3 mm. MRI positioning should include at least three sequences: T1-enhanced, T2 fat-suppressed, and DWI. Target and Normal Organ Contouring: GTVp (Gross Tumor Volume - Primary): Define the breast tumor target area based on MRI, CT, physical examination, and ultrasound
DRUG	Neoadjuvant Chemotherapy Combined with Immunotherapy	1. Recommended Chemotherapy Regimen and Doses: Albumin-bound Paclitaxel 260 mg/m² on Day 1, every 3 weeks (Q3W) × 4 cycles, followed by Epirubicin 90 mg/m² on Day 1 + Cyclophosphamide 600 mg/m² on Day 1, every 3 weeks (Q3W) × 4 cycles. 2. Recommended Immunotherapy Dose: Adebrelimab 1200 mg, repeated every 3 weeks, starting simultaneously with neoadjuvant chemotherapy and continuing for 1 year (including postoperative administration).

Timeline

• Start date: 2025-03-31
• Primary completion: 2028-09-10
• Completion: 2028-09-10
• First posted: 2025-04-03
• Last updated: 2025-04-03