HR+/HER2- Breast Cancer
Conditions
Brief 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
Interventions
DRUGSerplulimab
Serplulimab is administered intravenously
DRUGEpirubicin
Epirubicin ivgtt
DRUGAlbumin Paclitaxel
Albumin Paclitaxel ivgtt
Sponsors
Henan Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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). 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. 3.2
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. Other contraindications: Severe uncontrolled comorbidities deemed by investigators to contraindicate chemotherapy or PD-1 inhibitor therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PCR rate | At the time of surgery | Total pathological complete response |
| PCR rate in PDL1 positive subgroup | At the time of surgery | Total pathological complete response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EFS | 5-10 years | • Event-free survival (EFS) |
| DFS | 5-10 years | Disease-free survival (DFS) |
| adverse events | up to 1 year | Evaluate the nature, incidence and severity of chemotherapy adverse events according to CTCAE 5.0 |
Countries
China
Contacts
CONTACTZhenzhen Liu, Dr.
Outcome results
None listed