NCT06819319

SHR-A2102 Combined With Adebrelimab as Neoadjuvant Therapy for Early Triple-Negative Breast Cancer

A Phase II Study of SHR-A2102 in Combination With Adebrelimab as Neoadjuvant Therapy for Early Triple-Negative Breast Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, open-label, multicenter Phase II study evaluating the efficacy and safety of of SHR-A2102 in combination with Adebrelimab in Early Triple-Negative Breast Cancer(TNBC)

Detailed description

This study plans to enroll patients with early-stage TNBC. The patients will first receive 8 cycles of neoadjuvant therapy, with imaging examinations conducted every 2 cycles to evaluate the treatment response. Subjects who complete the 8 cycles and are suitable for surgery will undergo surgical treatment after the completion of neoadjuvant therapy. The postoperative adjuvant therapy will last for one year. Subjects will continue medication until surgery is completed, or until disease progression, intolerable toxicity, withdrawal of informed consent, or when the investigator determines that medication must be terminated.

Conditions

• TNBC - Triple-Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	SHR-A2102 ; Adebrelimab injection	SHR-A2102 is administered intravenously, Adebrelimab is administered intravenously

Timeline

• Start date: 2025-06-23
• Primary completion: 2026-12-31
• Completion: 2030-12-31
• First posted: 2025-02-11
• Last updated: 2025-06-23