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

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

Study Overview

• Status: Recruiting
• Conditions: HR+/HER2- Breast Cancer
• Intervention / Treatment: Drug: Serplulimab; Drug: Epirubicin; Drug: Albumin Paclitaxel

• Study Type: Interventional
• Enrollment (Estimated): 357
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Zhenzhen Liu, Dr.; Phone Number: 13603862755; Email: liuzhenzhen73@126.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Recruiting
      • Henan Cancer Hospital
      • Contact: Zhenzhen Liu, PHD; Phone Number: 13603862755; Email: zlyyliuzhenzhen0800@zzu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Treatment group1; NabPE+Serplulimab group（Epirubicin ivgtt on Day 1+Albumin Paclitaxel ivgtt on Day 1+Serplulimab ivgtt on Day 3）	Drug: Serplulimab; Serplulimab is administered intravenously; Drug: Epirubicin; Epirubicin ivgtt; Drug: Albumin Paclitaxel; Albumin Paclitaxel ivgtt
Experimental: Experimental: Treatment group2; NabPE+Serplulimab group（Epirubicin ivgtt on Day 1+Albumin Paclitaxel ivgtt on Day 1+Serplulimab ivgtt on Day 1）	Drug: Serplulimab; Serplulimab is administered intravenously; Drug: Epirubicin; Epirubicin ivgtt; Drug: Albumin Paclitaxel; Albumin Paclitaxel ivgtt
Active Comparator: Control group; NabPE(Epirubicin ivgtt on Day 1+Albumin Paclitaxel ivgtt on Day 1）	Drug: Epirubicin; Epirubicin ivgtt; Drug: Albumin Paclitaxel; Albumin Paclitaxel ivgtt

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PCR rate	Total pathological complete response	At the time of surgery
PCR rate in PDL1 positive subgroup	Total pathological complete response	At the time of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DFS	Disease-free survival (DFS)	5-10 years
EFS	• Event-free survival (EFS)	5-10 years
adverse events	Evaluate the nature, incidence and severity of chemotherapy adverse events according to CTCAE 5.0	up to 1 year

Collaborators and Investigators

• Sponsor: Henan Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2030

Study Registration Dates

• First Submitted: February 5, 2025
• First Submitted That Met QC Criteria: March 2, 2025
• First Posted (Actual): March 6, 2025

Study Record Updates

• Last Update Posted (Actual): June 23, 2025
• Last Update Submitted That Met QC Criteria: June 20, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Antibiotics, Antineoplastic; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Topoisomerase Inhibitors; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Paclitaxel; Epirubicin
• Other Study ID Numbers: HELEN-018plus

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No