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

NCT06860529 | Recruiting Phase 2

• 1 other identifier: HELEN-018plus
• Study Type: interventional
• Target: 357
• Locations: 1 country
• Sites: 1

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

Conditions

HR+/HER2- Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• EFS

  5-10 years

• DFS

  5-10 years

• adverse events

  up to 1 year

Study Arms (3)

Experimental: Treatment group1

EXPERIMENTAL

NabPE+Serplulimab group（Epirubicin ivgtt on Day 1+Albumin Paclitaxel ivgtt on Day 1+Serplulimab ivgtt on Day 3）

Drug: Serplulimab; Drug: Epirubicin; Drug: Albumin Paclitaxel

Experimental: Treatment group2

EXPERIMENTAL

NabPE+Serplulimab group（Epirubicin ivgtt on Day 1+Albumin Paclitaxel ivgtt on Day 1+Serplulimab ivgtt on Day 1）

Drug: Serplulimab; Drug: Epirubicin; Drug: Albumin Paclitaxel

Control group

ACTIVE COMPARATOR

NabPE(Epirubicin ivgtt on Day 1+Albumin Paclitaxel ivgtt on Day 1）

Drug: Epirubicin; Drug: Albumin Paclitaxel

Interventions

Serplulimab DRUG

Serplulimab is administered intravenously

Experimental: Treatment group1; Experimental: Treatment group2

Epirubicin DRUG

Epirubicin ivgtt

Control group; Experimental: Treatment group1; Experimental: Treatment group2

Albumin Paclitaxel DRUG

Albumin Paclitaxel ivgtt

Control group; Experimental: Treatment group1; Experimental: Treatment group2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan cancer hospital

Zhengzhou, Henan, 450000, China

RECRUITING

MeSH Terms

Interventions

Epirubicin

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Central Study Contacts

Zhenzhen Liu, Dr.

CONTACT

13603862755; liuzhenzhen73@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: March 6, 2025
• Study Start: April 15, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2030
• Last Updated: June 23, 2025

Record last verified: 2025-06

Locations

CN (1)