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

Sponsor
RenJi Hospital
Study ID
NCT07283692
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Mar 1, 2026
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Sep 30, 2031

Study Design

Enrollment
46 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: neoadjuvant serplulimab
    serplulimab in combination with weekly paclitaxel and carboplatin as neoadjuvant therapy

Primary Outcome Measure

Proportion of patients with pCR [ Time Frame: 1-2 weeks after surgery ]

Central Contacts

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