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

ConditionTriple Negative Breast Cancer

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexFemale

Age18-70

SponsorRenJi Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Single group

Treatments tested in this trial

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

Treatment groups

46 Participants

are divided into 1 treatment group

Group A: neoadjuvant serplulimabExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

Proportion of patients with pCR

Number of patients with pathological complete response/Number of all eligible patients

Time frame

1-2 weeks after surgery

Secondary outcomes

Proportion of patients with adverse events

Number of patients with adverse events during neoadjuvant therapy assessed according to the NCI CTCAE v5.0/Number of all eligible patients

Time frame

From the date of starting neoadjuvant therapy to the end of the treatment (up to approximately 1 year)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RenJi Hospital

Lead sponsor

Source ClinicalTrials.gov

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