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

Phase 2

Recruiting

• Conditions: HR+/HER2- Breast Cancer
• Interventions: Drug: Serplulimab; Drug: Epirubicin; Drug: Albumin Paclitaxel

• Registration Number: NCT06860529
• Lead Sponsor: Henan Cancer Hospital

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-05
• Study First Submitted QC: 2025-03-02
• Study First Posted: 2025-03-06
• Study Start: 2025-04-15
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-20
• Last Update Posted: 2025-06-23
• Primary Completion: 2028-03-31
• Study Completion: 2030-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 357

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: Treatment group1	Serplulimab	NabPE+Serplulimab group（Epirubicin ivgtt on Day 1+Albumin Paclitaxel ivgtt on Day 1+Serplulimab ivgtt on Day 3）
Experimental: Treatment group1	Epirubicin	NabPE+Serplulimab group（Epirubicin ivgtt on Day 1+Albumin Paclitaxel ivgtt on Day 1+Serplulimab ivgtt on Day 3）
Experimental: Treatment group1	Albumin Paclitaxel	NabPE+Serplulimab group（Epirubicin ivgtt on Day 1+Albumin Paclitaxel ivgtt on Day 1+Serplulimab ivgtt on Day 3）
Experimental: Treatment group2	Serplulimab	NabPE+Serplulimab group（Epirubicin ivgtt on Day 1+Albumin Paclitaxel ivgtt on Day 1+Serplulimab ivgtt on Day 1）
Experimental: Treatment group2	Epirubicin	NabPE+Serplulimab group（Epirubicin ivgtt on Day 1+Albumin Paclitaxel ivgtt on Day 1+Serplulimab ivgtt on Day 1）
Experimental: Treatment group2	Albumin Paclitaxel	NabPE+Serplulimab group（Epirubicin ivgtt on Day 1+Albumin Paclitaxel ivgtt on Day 1+Serplulimab ivgtt on Day 1）
Control group	Epirubicin	NabPE(Epirubicin ivgtt on Day 1+Albumin Paclitaxel ivgtt on Day 1）
Control group	Albumin Paclitaxel	NabPE(Epirubicin ivgtt on Day 1+Albumin Paclitaxel ivgtt on Day 1）

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Henan cancer hospital; 🇨🇳 Zhengzhou, Henan, China