Neoadjuvant Serplulimab Plus Weekly Paclitaxel and Carboplatin in TNBC (Neo-SERPENT)

NCT07283692 | Not Yet Recruiting Phase 2

• 1 other identifier: LY2025-277-A
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This is an prospective, open label, multicenter study to evaluate the efficacy and safety of neoadjuvant serplulimab plus weekly paclitaxel and carboplatin in patients with triple-negative breast cancer.

Conditions

Triple Negative Breast Cancer

Keywords

breast cancer; neoadjuvant; serplulimab

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with pCR

  Number of patients with pathological complete response/Number of all eligible patients

  1-2 weeks after surgery

Secondary Outcomes (1)

• Proportion of patients with adverse events

  From the date of starting neoadjuvant therapy to the end of the treatment (up to approximately 1 year)

Study Arms (1)

neoadjuvant serplulimab

EXPERIMENTAL

serplulimab in combination with weekly paclitaxel and carboplatin as neoadjuvant therapy

Drug: Serplulimab; Drug: Paclitaxel; Drug: Carboplatin

Interventions

Serplulimab DRUG

1.5mg/kg qw, start from C1D15

neoadjuvant serplulimab

Paclitaxel DRUG

80mg/m\^2 qw

neoadjuvant serplulimab

Carboplatin DRUG

AUC=1.5, D1, 8, 15, every 28 days

neoadjuvant serplulimab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female, Aged ≥18 and ≤70 years
• Histologically confirmed triple negative breast cancer (ER\<10%, PR\<10%, and HER2 negative)
• Subjects with at least one evaluable lesion
• ECOG 0-1
• Adequate organ function

You may not qualify if:

• Metastatic disease (Stage IV)
• Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test;Female patients of childbearing age that are reluctant to take effective contraceptive measures throughout the trial period

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, 200127, China

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Breast Neoplasms

Interventions

Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Wenjin Yin, M.D.

  Renji Hospital,School of Medicine, Shanghai Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenjin Yin, M.D.

CONTACT

86(21)68385569; yinwenjin@renji.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief of Breast Surgery Department

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 16, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): September 1, 2031
• Last Updated: February 3, 2026

Record last verified: 2026-02

Locations

CN (1)