MedTrace Logo

A Randomized Study of JS004 and Toripalimab Combined With Chemotherapy vs Toripalimab Combined With Chemotherapy vs Chemotherapy Alone as Neoadjuvant Therapy for Stage II-III Triple-negative Breast Cancer (TNBC).

NCT07101614 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2025-08-03

No results posted yet for this study

Summary

The objective of this study is to evaluate the efficacy and safety of chemotherapy plus toripalimab, with or without JS004,as neoadjuvant therapy for patients with triple-negative breast cancer (TNBC). TNBC patients were randomly assigned in a 2:2:1 ratio to receive either JS004 plus toripalimab plus chemotherapy, toripalimab plus chemotherapy, or chemotherapy alone.Surgery will be performed within 5 weeks after the last dose of neoadjuvant treatment.

Conditions

  • TNBC - Triple-Negative Breast Cancer

Interventions

DRUG

JS004 in combination with toripalimab and chemotherapy

BTLA inhibitor (JS004):200mg, IV infusion , d1, Q3W;(1-24 week) Toripalimab:240mg, IV infusion , d1, Q3W;(1-24 week) Carboplatin: IV infusion,AUC=5, d1,q3w(OR AUC=1.5,d1,qw);(1-12 week) Paclitaxel:IV infusion,80 mg/m2,qw;(1-12 week) Doxorubicin:IV infusion,60 mg/m2,q3w(OR Epirubicin:IV infusion,90 mg/m2,q3w);(13-24 week) Cyclophosphamide:IV infusion,600 mg/m2,q3w(13-24 week)

DRUG

Toripalimab and chemotherapy

Toripalimab:240mg, IV infusion , d1, Q3W;(1-24 week) Carboplatin: IV infusion,AUC=5, d1,q3w(OR AUC=1.5,d1,qw);(1-12 week) Paclitaxel:IV infusion,80 mg/m2,qw;(1-12 week) Doxorubicin:IV infusion,60 mg/m2,q3w(OR Epirubicin:IV infusion,90 mg/m2,q3w);(13-24 week) Cyclophosphamide:IV infusion,600 mg/m2,q3w(13-24 week)

DRUG

Chemotherapy

Carboplatin: IV infusion,AUC=5, d1,q3w(OR AUC=1.5,d1,qw);(1-12 week) Paclitaxel:IV infusion,80 mg/m2,qw;(1-12 week) Doxorubicin:IV infusion,60 mg/m2,q3w(OR Epirubicin:IV infusion,90 mg/m2,q3w);(13-24 week) Cyclophosphamide:IV infusion,600 mg/m2,q3w(13-24 week)

Sponsors & Collaborators

  • Shengjing Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2027-11-30
Completion
2028-11-30
FDA Drug
Yes

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07101614 on ClinicalTrials.gov