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

• Status Verified: 2025-01
• Study First Submitted: 2025-02-05
• Study First Submitted QC: 2025-02-05
• Last Update Submitted: 2025-02-05
• Study First Posted: 2025-02-11
• Last Update Posted: 2025-02-11
• Study Start: 2025-03-01
• Primary Completion: 2026-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

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

Inclusion Criteria

1. Female patients aged ≥ 18 years;
2. Histopathologically confirmed triple-negative invasive breast cancer, with no previous systemic anti-cancer treatment specifically for breast cancer;
3. At least one measurable target lesion according to RECIST V1.1;
4. ECOG performance status score of 0 to 1;
5. Life expectancy ≥12 weeks;
6. Adequate bone marrow reserve and organ system function reserve;
7. Participants should be able and willing to comply with the study protocol requirement;

Exclusion Criteria

1. Breast cancer not histologically confirmed;
2. Previously been treated with any anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.);
3. Previous treatment with anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death ligand 1 (anti-PD-L1), or anti-PD-L2 drugs, or other immunotherapy;
4. Concurrent receipt of any other form of anti-cancer therapy;
5. History of a second primary malignancy, except for adequately treated skin cancer;
6. Participation in other drug clinical trials within 4 weeks before enrollment;
7. Major surgical procedures unrelated to breast cancer within 4 weeks prior to the first drug administration, or not fully recovered from such procedures;
8. Presence of any active autoimmune disease or history of autoimmune disease with potential for recurrence;
9. Uncontrolled or significant cardiovascular and cerebrovascular diseases;
10. Subjects with known or suspected interstitial pneumonia;
11. Presence of active hepatitis B, hepatitis C, liver cirrhosis; or severe infections requiring antibiotic, antiviral, or antifungal drug control;
12. Known inherited or acquired bleeding and thrombotic tendencies;
13. Known allergy or contraindication to the study drug and its excipients;
14. Pregnant or lactating female patients;
15. History of definite neurological or mental disorders, or any other conditions that the investigator believes make the patient unsuitable for participating in this study.

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)