RecruitingPhase 2NCT06860529

Serplulimab Combined With Chemotherapy for Early-stage HR+/HER2- Breast Cancer

Sponsor

Henan Cancer Hospital

Enrollment

357 participants

Start Date

Apr 15, 2025

Study Type

INTERVENTIONAL

Conditions

HR+/HER2- Breast Cancer

Summary

The neoadjuvant treatment options commonly used for HR+/HER2- breast cancer are mainly anthracycline sequential or combined with paclitaxel chemotherapy regimens. Several clinical studies have confirmed that albumin paclitaxel is more effective than solvent-based paclitaxel, and therefore, albumin paclitaxel in combination with epirubicin has also become a commonly used chemotherapy regimen in clinical practice. The aim of this study was to explore the efficacy and safety of the Serplulimab combined with nab-paclitaxel and epirubicin in the neoadjuvant treatment of HR+/HER2- breast cancer

Eligibility

Min Age: 18 Years

Inclusion Criteria21

Patients must meet all of the following criteria to be eligible:
Age: ≥18 years old.
Clinical-pathological confirmation:
cT2-cT4 breast cancer, or cT1c with axillary lymph node metastasis.
Histopathologically confirmed HR+/HER2- invasive breast cancer:
ER and/or PR positive (IHC nuclear staining ≥1%).
HER2-negative (IHC 0 or 1+ without FISH testing, or IHC 2+ with FISH-negative amplification).
Ki67 ≥20%.
Clinically measurable lesions:
Measurable lesions confirmed by ultrasound, mammography, or MRI (optional) within 1 month prior to randomization.
Adequate organ and bone marrow function (within 1 month prior to chemotherapy):
Absolute neutrophil count (ANC) ≥2.0 × 10\^9/L.
Hemoglobin ≥90 g/L.
Platelet count ≥100 × 10\^9/L.
Total bilirubin \<1.5 × ULN (upper limit of normal).
Creatinine \<1.5 × ULN.
AST/ALT \<1.5 × ULN.
Cardiac function: Left ventricular ejection fraction (LVEF) ≥55% by echocardiography.
Reproductive status: Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to randomization.
ECOG performance status: ≤1.
Informed consent: Signed written informed consent.

Exclusion Criteria15

Patients meeting any of the following criteria will be excluded:
Evidence of metastatic breast cancer:
Chest/abdominal CT and bone scan required at any time from diagnosis to randomization to exclude metastasis.
PET/CT may substitute for other imaging modalities.
Prior systemic therapy: Chemotherapy, endocrine therapy, targeted therapy, or radiotherapy for the current breast cancer.
Second primary malignancy, except:
Adequately treated non-melanoma skin cancer.
Prior immunotherapy: Treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or other immune checkpoint inhibitors.
Immune-related conditions:
Diagnosed immunodeficiency or active autoimmune disease.
Severe cardiopulmonary disease: Uncontrolled or clinically significant.
Active hepatitis: Hepatitis B or C with detectable viral load.
Transplant history: Prior organ or bone marrow transplantation.
Pregnancy or lactation: Pregnant or breastfeeding women.
Other contraindications: Severe uncontrolled comorbidities deemed by investigators to contraindicate chemotherapy or PD-1 inhibitor therapy.