Neoadjuvant Serplulimab Plus Weekly Paclitaxel and Carboplatin in TNBC (Neo-SERPENT)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Serplulimab, Paclitaxel, Carboplatin.
- Who it may be relevant to
- Registry conditions: Triple Negative Breast Cancer. Basic parameters: 18 years — 70 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
NEOadjuvant SERplulimab Plus Weekly PaclitaxEl and carboplatiN in Triple-negative Breast Cancer: a Prospective, Single-arm, Multicenter, Phase 2 Clinical Trial
Overview
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 outcome measures
- Proportion of patients with pCR [Time frame: 1-2 weeks after surgery]
Secondary outcome measures (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)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Renji Hospital, School of Medicine, Shanghai Jiaotong University — Shanghai
Identifiers
NCT: NCT07283692 · LY2025-277-A