NCT07101614View on ClinicalTrials.gov

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).

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

125

Participants

Timeline

Start Date

September 1, 2025

Primary Completion Date

November 30, 2027

Study Completion Date

November 30, 2028

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)"

All Listed Sponsors
lead

Shengjing Hospital

OTHER