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

Phase 2

Not yet 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
• Status Verified: 2025-03
• Study Start: 2025-03-01
• Study First Submitted QC: 2025-03-02
• Last Update Submitted: 2025-03-02
• Study First Posted: 2025-03-06
• Last Update Posted: 2025-03-06
• Primary Completion: 2028-03-31
• Study Completion: 2030-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 357

Inclusion Criteria

1. Age>=18 years old

2. cT2 - cT4d, or cT1c with axillary lymph node metastasis confirmed clinically and pathologically；

3. Pathologically proven HR+/HER2- breast cancer:

   defined as:

   • positive for ER or PR (IHC nuclear staining >1%)
   • Her-2 negative (IHC 0, 1+ without FISH, or IHC 2+ with no amplification by FISH)；

4. Has clinically measurable lesions:Measurable lesions on ultrasound, mammography, or MR (optional) within 1 month before randomization；

5. Organ and bone marrow function tests within 1 month before chemotherapy suggest no contraindications to chemotherapy；

6. Cardiac ultrasound EF value ≧55%；

7. Females of childbearing age, with a negative serum pregnancy test 14 days before randomization;

8. ECOG score≤1 point;

9. Sign informed consent；

Exclusion Criteria

1. The patient has evidence of metastatic breast cancer；
2. For this disease, chemotherapy, endocrine therapy, targeted therapy, radiation therapy, etc. have been received;
3. The patient has a second primary malignancy other than adequately treated skin cancer;
4. The patient has been treated with anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death ligand 1 (anti-PD-L1) or anti-PD-L2 drugs, or other immunotherapy；
5. The patient has been diagnosed with immunodeficiency disease or autoimmune disease;
6. The patient has severe lung or heart disease;
7. The patient has active hepatitis B and C;
8. The patient has a history of organ transplantation or bone marrow transplantation;
9. pregnant or breastfeeding women;
10. The investigators considered chemotherapy contraindicated due to serious, uncontrolled other medical conditions.

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