Neoadjuvant Serplulimab Plus Weekly Paclitaxel and Carboplatin in TNBC (Neo-SERPENT)
NCT ID: NCT07283692
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
46 participants
INTERVENTIONAL
2025-12-31
2031-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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neoadjuvant serplulimab
serplulimab in combination with weekly paclitaxel and carboplatin as neoadjuvant therapy
Serplulimab
1.5mg/kg qw, start from C1D15
Paclitaxel
80mg/m\^2 qw
Carboplatin
AUC=1.5, D1, 8, 15, every 28 days
Interventions
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Serplulimab
1.5mg/kg qw, start from C1D15
Paclitaxel
80mg/m\^2 qw
Carboplatin
AUC=1.5, D1, 8, 15, every 28 days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
FEMALE
No
Sponsors
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RenJi Hospital
OTHER
Responsible Party
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Wenjin Yin
Deputy Chief of Breast Surgery Department
Principal Investigators
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Wenjin Yin, M.D.
Role: PRINCIPAL_INVESTIGATOR
Renji Hospital,School of Medicine, Shanghai Jiaotong University
Locations
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Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, , China
Countries
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Central Contacts
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Other Identifiers
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LY2025-277-A
Identifier Type: -
Identifier Source: org_study_id