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

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)

Study Overview

• Status: Not yet recruiting
• Conditions: TNBC - Triple-Negative Breast Cancer
• Intervention / Treatment: Drug: SHR-A2102 ; Adebrelimab injection

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 Type: Interventional
• Enrollment (Estimated): 52
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Zhenzhen Liu, Dr.; Phone Number: 13603862755; Email: liuzhenzhen73@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

3.1 Inclusion Criteria

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:

Absolute neutrophil count (ANC) ≥2.0 ×10^9/L.

Platelets ≥100 ×10^9/L.

Hemoglobin ≥100 g/L.

Liver/kidney function:

Albumin ≥3.0 g/dL.

Total bilirubin <1.5 × ULN.

ALT/AST <1.5 × ULN.

Alkaline phosphatase ≤2.5 × ULN.

BUN and serum creatinine <1.5 × ULN or creatinine clearance >60 mL/min (Cockcroft-Gault formula).

Coagulation: PT and APTT ≤1.5 × ULN.

Cardiac function: LVEF ≥55% by echocardiography (ECHO).

QT interval: QTcF ≤470 ms.

Reproductive status:

Premenopausal women: Negative serum pregnancy test within 14 days before treatment.

Non-lactating.

All subjects must use effective barrier contraception during treatment and for 6 months post-treatment.

Informed consent: Willing to sign informed consent and comply with study procedures.

3.2 Exclusion Criteria

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.

Autoimmune diseases:

Active autoimmune disease or history of autoimmune disease with potential recurrence (e.g., autoimmune hepatitis, uveitis, thyroid dysfunction requiring systemic treatment).

Exceptions: Vitiligo, psoriasis, alopecia, controlled childhood asthma, or type 1 diabetes managed with insulin.

Immunodeficiency: HIV-positive, congenital/acquired immunodeficiency disorders.

Cardiovascular disease:

History within 6 months: Myocardial infarction, stroke (excluding lacunar infarct), pulmonary embolism, unstable angina, NYHA Class III/IV heart failure.

Clinically significant arrhythmia, primary cardiomyopathy, atrial fibrillation (EHRA ≥2b), uncontrolled hypertension, or QTcF >470 ms.

Pulmonary disease:

Interstitial lung disease, idiopathic pulmonary fibrosis, severe COPD/asthma, or autoimmune/collagen vascular diseases with pulmonary involvement.

Infections:

Active hepatitis B (HBsAg+ with HBV DNA ≥500 IU/mL), hepatitis C (HCV RNA > ULN), cirrhosis, or severe infections requiring antimicrobial therapy.

Bleeding/thrombosis disorders: Hereditary/acquired bleeding or thrombotic tendencies (e.g., hemophilia).

Hypersensitivity: Allergy or contraindication to study drug components.

Pregnancy/lactation: Pregnant, breastfeeding, or unwilling to use contraception.

Comorbidities: Uncontrolled conditions (e.g., hypertension, diabetes, active infections) contraindicating ADC or PD-L1 inhibitors.

Neurological/psychiatric disorders: Epilepsy, dementia, or other conditions deemed unsuitable by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experimental: Treatment group; 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; SHR-A2102 is administered intravenously, Adebrelimab is administered intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PCR rate	Total pathological complete response (tpCR: ypT0-is，ypN0)	At the time of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EFS	Event-free survival (EFS)	3-10 years
DFS	Disease-free survival (DFS)	5-10 years
DDFS	Distant disease-Free Survival (DDFS)	5-10 years

Collaborators and Investigators

• Sponsor: Henan Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 23, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: February 5, 2025
• First Submitted That Met QC Criteria: February 5, 2025
• First Posted (Actual): February 11, 2025

Study Record Updates

• Last Update Posted (Actual): June 23, 2025
• Last Update Submitted That Met QC Criteria: June 20, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms
• Other Study ID Numbers: HELEN-023; BC-NEO-IIT-SHR-A2102-SHR1316 (Other Identifier: Protocol Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No