Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT06908668
PHASE2

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

Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

170

Start Date

2025-03-31

Completion Date

2028-09-10

Last Updated

2025-04-03

Healthy Volunteers

No

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).