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

Shanghai Jiao Tong University

Status and phase: Not yet enrolling; Phase 2

Conditions: Triple Negative Breast Cancer

Treatments: Drug: Carboplatin; Drug: Serplulimab; Drug: Paclitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT07283692

LY2025-277-A

Details and patient eligibility

About

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.

Enrollment: 46 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

neoadjuvant serplulimab

Experimental group

Description:

serplulimab in combination with weekly paclitaxel and carboplatin as neoadjuvant therapy

Treatment:

Drug: Paclitaxel

Drug: Serplulimab

Drug: Carboplatin