Serplulimab Combined With Chemotherapy for Early-stage HR+/HER2- Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 357
- 试验地点
- 2
- 主要终点
- PCR rate
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •3.1 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).
- •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: ≤
- •Informed consent: Signed written informed consent.
排除标准
- •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.
研究组 & 干预措施
Experimental: Treatment group1
NabPE+Serplulimab group（Epirubicin ivgtt on Day 1+Albumin Paclitaxel ivgtt on Day 1+Serplulimab ivgtt on Day 3）
干预措施: Epirubicin (Drug)
Experimental: Treatment group1
NabPE+Serplulimab group（Epirubicin ivgtt on Day 1+Albumin Paclitaxel ivgtt on Day 1+Serplulimab ivgtt on Day 3）
干预措施: Albumin Paclitaxel (Drug)
Experimental: Treatment group2
NabPE+Serplulimab group（Epirubicin ivgtt on Day 1+Albumin Paclitaxel ivgtt on Day 1+Serplulimab ivgtt on Day 1）
干预措施: Serplulimab (Drug)
Control group
NabPE(Epirubicin ivgtt on Day 1+Albumin Paclitaxel ivgtt on Day 1）
干预措施: Albumin Paclitaxel (Drug)
Control group
NabPE(Epirubicin ivgtt on Day 1+Albumin Paclitaxel ivgtt on Day 1）
干预措施: Epirubicin (Drug)
Experimental: Treatment group2
NabPE+Serplulimab group（Epirubicin ivgtt on Day 1+Albumin Paclitaxel ivgtt on Day 1+Serplulimab ivgtt on Day 1）
干预措施: Albumin Paclitaxel (Drug)
Experimental: Treatment group2
NabPE+Serplulimab group（Epirubicin ivgtt on Day 1+Albumin Paclitaxel ivgtt on Day 1+Serplulimab ivgtt on Day 1）
干预措施: Epirubicin (Drug)
Experimental: Treatment group1
NabPE+Serplulimab group（Epirubicin ivgtt on Day 1+Albumin Paclitaxel ivgtt on Day 1+Serplulimab ivgtt on Day 3）
干预措施: Serplulimab (Drug)
结局指标
主要结局
PCR rate
时间窗: At the time of surgery
Total pathological complete response
PCR rate in PDL1 positive subgroup
时间窗: At the time of surgery
Total pathological complete response
次要结局
- EFS(5-10 years)
- DFS(5-10 years)
- adverse events(up to 1 year)
研究者
Zhenzhen Liu
Professor
Henan Cancer Hospital