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RecruitingPhase 2NCT07283692

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

NEOadjuvant SERplulimab Plus Weekly PaclitaxEl and carboplatiN in Triple-negative Breast Cancer: a Prospective, Single-arm, Multicenter, Phase 2 Clinical Trial

Sponsor

RenJi Hospital

Enrollment

46 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

Triple-Negative Breast Cancer

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Inclusion Criteria5

  • 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

Exclusion Criteria2

  • 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

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Interventions

DRUGSerplulimab

1.5mg/kg qw, start from C1D15

DRUGPaclitaxel

80mg/m\^2 qw

DRUGCarboplatin

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

Locations(1)

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, China

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NCT07283692

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