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

NCT06908668 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2025-04-03

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-31
Primary Completion
2028-09-10
Completion
2028-09-10

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06908668 on ClinicalTrials.gov