Serplulimab Combined With Chemotherapy for Early-stage HR+/HER2- Breast Cancer
NCT ID: NCT06860529
Last Updated: 2025-06-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
357 participants
INTERVENTIONAL
2025-04-15
2030-03-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental: Treatment group2
NabPE+Serplulimab group（Epirubicin ivgtt on Day 1+Albumin Paclitaxel ivgtt on Day 1+Serplulimab ivgtt on Day 1）
Serplulimab
Serplulimab is administered intravenously
Epirubicin
Epirubicin ivgtt
Albumin Paclitaxel
Albumin Paclitaxel ivgtt
Experimental: Treatment group1
NabPE+Serplulimab group（Epirubicin ivgtt on Day 1+Albumin Paclitaxel ivgtt on Day 1+Serplulimab ivgtt on Day 3）
Serplulimab
Serplulimab is administered intravenously
Epirubicin
Epirubicin ivgtt
Albumin Paclitaxel
Albumin Paclitaxel ivgtt
Control group
NabPE(Epirubicin ivgtt on Day 1+Albumin Paclitaxel ivgtt on Day 1）
Epirubicin
Epirubicin ivgtt
Albumin Paclitaxel
Albumin Paclitaxel ivgtt
Interventions
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Serplulimab
Serplulimab is administered intravenously
Epirubicin
Epirubicin ivgtt
Albumin Paclitaxel
Albumin Paclitaxel ivgtt
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Henan Cancer Hospital
OTHER_GOV
Responsible Party
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Zhenzhen Liu
Professor
Locations
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Henan cancer hospital
Zhengzhou, Henan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HELEN-018plus
Identifier Type: -
Identifier Source: org_study_id
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