Serplulimab Combined With Chemotherapy for Early-stage HR+/HER2- Breast Cancer

Sponsor
Henan Cancer Hospital
Study ID
NCT06860529
Phase
PHASE2
Status
Recruiting
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Conditions

  • HR+/HER2- Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Serplulimab — DRUG
    Serplulimab is administered intravenously
  • Epirubicin — DRUG
    Epirubicin ivgtt
  • Albumin Paclitaxel — DRUG
    Albumin Paclitaxel ivgtt

Study Details

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

Key Dates

Start date
Apr 15, 2025
Status verified
Jun 2025
Primary completion
Mar 31, 2028
Completion
Mar 31, 2030

Study Design

Enrollment
357 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: Treatment group1
    NabPE+Serplulimab group（Epirubicin ivgtt on Day 1+Albumin Paclitaxel ivgtt on Day 1+Serplulimab ivgtt on Day 3）
  • Experimental: Experimental: Treatment group2
    NabPE+Serplulimab group（Epirubicin ivgtt on Day 1+Albumin Paclitaxel ivgtt on Day 1+Serplulimab ivgtt on Day 1）
  • Active Comparator: Control group
    NabPE(Epirubicin ivgtt on Day 1+Albumin Paclitaxel ivgtt on Day 1）

Primary Outcome Measure

PCR rate [ Time Frame: At the time of surgery ]

Central Contacts

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