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

NCT06819319 | Not Yet Recruiting Phase 2

• 2 other identifiers: HELEN-023BC-NEO-IIT-SHR-A2102-SHR1316
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

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)

Conditions

TNBC - Triple-Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• PCR rate

  Total pathological complete response (tpCR: ypT0-is，ypN0)

  At the time of surgery

Secondary Outcomes (3)

• EFS

  3-10 years

• DFS

  5-10 years

• DDFS

  5-10 years

Study Arms (1)

Experimental: Treatment group

EXPERIMENTAL

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.

Drug: SHR-A2102 ; Adebrelimab injection

Interventions

SHR-A2102 ; Adebrelimab injection DRUG

SHR-A2102 is administered intravenously, Adebrelimab is administered intravenously

Experimental: Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must meet all of the following criteria to be eligible:
• Age and gender: Female, ≥18 years old.
• Histopathological confirmation:
• Invasive breast cancer confirmed by histopathology.
• No prior systemic anti-tumor therapy for breast cancer.
• Triple-negative PD-L1-positive breast cancer:
• ER/PR-negative (IHC nuclear staining \<10%).
• HER2-negative (IHC 0/1+ without FISH testing or IHC 2+ with FISH-negative amplification).
• PD-L1 Combined Positive Score (CPS) ≥1.
• Tumor stage: T1c-T2, N0-1 or T1a-T1b, N1 (per AJCC 8th Edition criteria).
• Measurable lesion: At least one measurable target lesion per RECIST v1.1.
• ECOG performance status: 0-1.
• Life expectancy: ≥3 months.
• Adequate organ and bone marrow function (within 1 month prior to treatment, without corrective therapy within 14 days before first dose):
• Bone marrow:

You may not qualify if:

• Subjects meeting any of the following criteria will be excluded:
• Unconfirmed diagnosis: Breast cancer not histopathologically confirmed.
• Specific subtypes: Bilateral, inflammatory, or occult breast cancer.
• Metastatic disease: Evidence of metastatic breast cancer (excluded via chest/abdominal CT and bone scan; PET/CT allowed as alternative).
• Prior anti-tumor therapy:
• Chemotherapy, radiotherapy, targeted therapy, or endocrine therapy for breast cancer.
• Curative radiotherapy within 4 weeks or palliative radiotherapy within 2 weeks before first dose.
• Prior immunotherapy: Anti-PD-1, anti-PD-L1, anti-PD-L2, or other immune checkpoint inhibitors.
• Concurrent anti-tumor therapy: Any other anti-cancer treatments during the study.
• Second primary malignancy: Except adequately treated non-melanoma skin cancer.
• Transplant history: Prior organ or bone marrow transplantation.
• Recent clinical trials: Participation in another drug trial within 4 weeks prior to enrollment.
• Immunosuppressive therapy: Systemic corticosteroids (\>10 mg/day prednisone equivalent) or immunosuppressants within 2 weeks before first dose (excluding inhaled/topical steroids).
• Vaccination: Live or attenuated vaccines within 4 weeks before first dose.
• Major surgery: Non-breast-related major surgery within 4 weeks before first dose or incomplete recovery.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Zhenzhen Liu, Dr.

CONTACT

13603862755; liuzhenzhen73@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 11, 2025
• Study Start: June 23, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2030
• Last Updated: June 23, 2025

Record last verified: 2025-06