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

NCT06394661 | Active Not Recruiting Phase 2

• 1 other identifier: HELEN-018
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if serplulimab is effective in early HR+/HER2- breast cancer. It will also learn about the safety of serplulimab. The main questions it aims to answer are: Does serplulimab combined with neoadjuvant chemotherapy improve the pCR rate of early HR+/HER2- breast cancer? What medical problems do participants have when receiving serplulimab? Researchers will compare the effect of serplulimab combined with chemotherapy to the effect of chemotherapy reported in literature. Participants will: Receive serplulimab plus chemotherapy every 3 weeks for 6 cycles; All patients will receive surgery, and the primary end point is a pathological complete response at the time of definitive surgery; After definitive surgery, the participants will receive adjuvant serplulimab every 3 weeks for up to 6 months from the beginning of the treatment.

Conditions

Breast Cancer

Keywords

HR+ breast cancer; neoadjuvant; serplulimab

Outcome Measures

Primary Outcomes (1)

• pathological complete response

  After neoadjuvant chemotherapy and surgery, the resected specimen (breast + axilla) was free of any invasive cancer (ie, ypT0/is, ypN0)

  up to 24 weeks

Secondary Outcomes (4)

• Event-Free Survival (EFS)

  5-10 years

• DFS

  5-10 years

• Objective Response Rate (ORR)

  up to 24 weeks

• adverse events

  After each cycle of chemotherapy (21 days as 1 cycle)]

Other Outcomes (4)

• PDL1 expression

  up to 24 weeks

• next-generation sequencing (NGS)

  up to 24 weeks

• blood based biomarker

  up to 24 weeks

Study Arms (1)

Serplulimab group

EXPERIMENTAL

NabPE+Serplulimab group（Epirubicin 75mg/m2 ivgtt on Day 1+Albumin Paclitaxel 260mg/m2 ivgtt on Day 1+Serplulimab 4.5mg/Kg ivgtt on Day 3）every 3 weeks for 6 cycles. Then paticipants will receive surgery and Serplulimab will be given as monotherapy every 3 weeks up to 6 months from the beginning of the treatment.

Drug: Serplulimab+NabPE

Interventions

Serplulimab+NabPE DRUG

Serplulimab plus neoadjuvant nab-PE: Epirubicin 75mg/m2 ivgtt on Day 1+Albumin Paclitaxel 260mg/m2 ivgtt on Day 1+Serplulimab 4.5mg/Kg ivgtt on Day 3）

Serplulimab group

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:
• 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 B or C.
• 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 cacer hospital

Henan, Henan, 450008, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Zhenzhen Liu, PhD

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 28, 2024
• First Posted: May 1, 2024
• Study Start: April 28, 2024
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2028
• Last Updated: June 23, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)