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

Phase 2

Not yet recruiting

• Conditions: TNBC - Triple-Negative Breast Cancer
• Interventions: Drug: SHR-A2102 ; Adebrelimab injection

• Registration Number: NCT06819319
• Lead Sponsor: Henan Cancer Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2025-02-05
• Study First Submitted QC: 2025-02-05
• Study First Posted: 2025-02-11
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-20
• Study Start: 2025-06-23
• Last Update Posted: 2025-06-23
• Primary Completion: 2026-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: Treatment group	SHR-A2102 ; Adebrelimab injection	Subjects will receive four cycles of SHR-A2102 combined with adebrelimab therapy. Before the fifth cycle, efficacy is evaluated. If the response is PR/CR, the original regimen will be continued for another four cycles. If SD/PD or PR but deemed unbeneficial by the investigator, treatment will be switched to four cycles of TCb combined with pembrolizumab.

Primary Outcome Measures

Name	Time	Method
PCR rate	At the time of surgery	Total pathological complete response (tpCR: ypT0-is，ypN0)

Secondary Outcome Measures

Name	Time	Method
DFS	5-10 years	Disease-free survival (DFS)
DDFS	5-10 years	Distant disease-Free Survival (DDFS)
EFS	3-10 years	Event-free survival (EFS)