Serplulimab Combined With Chemotherapy for Early-stage HR+/HER2- Breast Cancer
Recruiting · NCT06860529 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
- ther contraindications: Severe uncontrolled comorbidities deemed by investigators to contraindicate chemotherapy or PD-1 inhibitor therapy.
Where it is running
1 location listed.
- Henan cancer hospital - Zhengzhou, Henan, China