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NCT Number: NCT07283692

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

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.

Recruiting

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Key information

Conditions

Triple Negative Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Neoplasms

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, 200127, China

Location status: Recruiting

Location contact

Wenjin Yin, M.D.

CONTACT

[email protected]

86(21)58852345

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Serplulimab

Drug

1.5mg/kg qw, start from C1D15

paclitaxel

Drug

80mg/m^2 qw

carboplatin

Drug

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

Primary outcomes

  1. Proportion of patients with pCR

    Time frame: 1-2 weeks after surgery

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

Secondary outcomes

  1. Proportion of patients with adverse events

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

    Number of patients with adverse events during neoadjuvant therapy assessed according to the NCI CTCAE v5.0/Number of all eligible patients

Study contacts

Contact information is provided by the study sponsor or research team.

Wenjin Yin, M.D.

CONTACT

[email protected]

86(21)68385569

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2031
First posted
Dec 16, 2025
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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