Recruiting
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.
ClinicalTrials.gov IDNCT07283692
PhasePHASE2
Enrollment46
SponsorRenJi Hospital
Age18 Years
SexFEMALE
Conditions studied
Triple Negative Breast Cancer
About this study
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.
Interventions
- Drug: Serplulimab — 1.5mg/kg qw, start from C1D15
- Drug: Paclitaxel — 80mg/m\^2 qw
- Drug: Carboplatin — AUC=1.5, D1, 8, 15, every 28 days
Primary outcomes
- Proportion of patients with pCR (1-2 weeks after surgery)
Eligibility information
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
Study locations
- Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, 200127 China
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.