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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

170

Participants

Timeline

Start Date

March 31, 2025

Primary Completion Date

September 10, 2028

Study Completion Date

September 10, 2028

Conditions
HER2-Negative Locally Advanced Breast Cancer
Interventions
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)."

All Listed Sponsors
lead

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER