NabPE With or Without Serplulimab for Early-stage HR+/HER2- Breast Cancer.

NCT06781281 | Recruiting

• 1 other identifier: HELEN-018RWS
• Study Type: observational
• Target: 709
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical study is to learn if serplulimab is effective in early HR+/HER2- breast cancer. This trial serves a prospective parallel control cohort for HELEN-018 (NCT). 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 begining of the treatment.

Conditions

Breast Cancer Invasive

Keywords

HR+/HER2-; PD1; Real-world study

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)

  24 weeks

Secondary Outcomes (4)

• Event-Free Survival (EFS)

  5-10 years

• DFS

  5-10 years

• Objective Response Rate (ORR)

  24 WEEKS

• adverse events

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

Study Arms (2)

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.

Drug: Serplulimab; Drug: NabPE

NabPE

Epirubicin 75mg/m2 ivgtt on Day 1+Albumin Paclitaxel 260mg/m2 ivgtt on Day 1, every 3 weeks for 6 cycles.

Drug: NabPE

Interventions

Serplulimab DRUG

Serplulimab

NabPE+Serplulimab group

NabPE DRUG

Epirubicin 75mg/m2 ivgtt +Albumin Paclitaxel 260mg/m2

NabPE; NabPE+Serplulimab group

Eligibility Criteria

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

Study Population

All female breast cancer patients diagnosed and scheduled to receive neoadjuvant chemotherapy

You may qualify if:

• Age\>=18 years old
• cT2 - cT4d, or cT1c with axillary lymph node metastasis confirmed clinically and pathologically；
• 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)；
• Has clinically measurable lesions:Measurable lesions on ultrasound, mammography, or MR (optional) within 1 month before randomization；
• Organ and bone marrow function tests within 1 month before chemotherapy suggest no contraindications to chemotherapy；
• Cardiac ultrasound EF value ≧55%；
• Females of childbearing age, with a negative serum pregnancy test 14 days before randomization;
• ECOG score≤1 point;
• Sign informed consent；

You may not qualify if:

• The patient has evidence of metastatic breast cancer；
• For this disease, chemotherapy, endocrine therapy, targeted therapy, radiation therapy, etc. have been received;
• The patient has a second primary malignancy other than adequately treated skin cancer;
• 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；
• The patient has been diagnosed with immunodeficiency disease or autoimmune disease;
• The patient has severe lung or heart disease;
• The patient has active hepatitis B and C;
• The patient has a history of organ transplantation or bone marrow transplantation;
• pregnant or breastfeeding women;
• The investigators considered chemotherapy contraindicated due to serious, uncontrolled other medical conditions.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan cancer hospital

Zhengzhou, China

RECRUITING

Central Study Contacts

Zhenzhen Liu, Dr.

CONTACT

13603862755; zlyyliuzhenzhen0800@zzu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: January 17, 2025
• Study Start: December 4, 2024
• Primary Completion (Estimated): November 28, 2026
• Study Completion (Estimated): November 28, 2030
• Last Updated: June 23, 2025

Record last verified: 2025-06

Locations

CN (1)