Actively Recruiting
Serplulimab Combined With Chemotherapy for Early-stage HR+/HER2- Breast Cancer
Led by Henan Cancer Hospital · Updated on 2025-06-23
357
Participants Needed
1
Research Sites
258 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Serplulimab Combined With Chemotherapy for Early-stage HR+/HER2- Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Clinical-pathological diagnosis of breast cancer stage cT2 to cT4, or cT1c with axillary lymph node metastasis
- Histopathologically confirmed HR+/HER2- invasive breast cancer with ER and/or PR positive (IHC nuclear staining 1%)
- HER2-negative status confirmed by IHC or FISH testing
- Ki67 proliferation index of 20% or higher
- Measurable lesions confirmed by ultrasound, mammography, or MRI within 1 month prior to randomization
- Adequate organ and bone marrow function within 1 month prior to chemotherapy, including ANC 2.0 � 10^9/L, hemoglobin 90 g/L, platelet count 100 � 10^9/L, total bilirubin <1.5 times the upper limit of normal, creatinine <1.5 times ULN, AST/ALT <1.5 times ULN
- Cardiac function with left ventricular ejection fraction 55% by echocardiography
- Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to randomization
- ECOG performance status of 1 or less
- Signed written informed consent
You will not qualify if you...
- Evidence of metastatic breast cancer confirmed by chest/abdominal CT and bone scan or PET/CT before randomization
- Prior systemic therapy for current breast cancer including chemotherapy, endocrine therapy, targeted therapy, or radiotherapy
- Second primary malignancy except treated non-melanoma skin cancer
- Prior immunotherapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or other immune checkpoint inhibitors
- Diagnosed immunodeficiency or active autoimmune disease
- Severe uncontrolled cardiopulmonary disease
- Active hepatitis B or C with detectable viral load
- History of organ or bone marrow transplantation
- Pregnant or breastfeeding women
- Severe uncontrolled comorbidities contraindicating chemotherapy or PD-1 inhibitor therapy as judged by investigators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Henan cancer hospital
Zhengzhou, Henan, China, 450000
Actively Recruiting
Research Team
Z
Zhenzhen Liu, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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