NCT07101614

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).

An Open-label, Randomized, Multi-center, Multi-cohort Clinical 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).

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 125 (estimated)
• Sponsor: Shengjing Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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)

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-11-30
• Completion: 2028-11-30
• First posted: 2025-08-03
• Last updated: 2025-08-03

Regulatory

• FDA-regulated drug study