drugset
drugset / Trial / 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).

NCT07101614 ↗

Phase 2 Not yet recruiting 125 enrolled Shengjing Hospital
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2025-09-01
Primary completion
2027-11-30
Completion
2028-11-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Tifcemalimab Monoclonal antibody 200 mg Intravenous
Subject Toripalimab Monoclonal antibody 240 mg Intravenous
Background Carboplatin Small molecule — Intravenous
Background Cyclophosphamide Other / unclassified 600 mg/m2 Intravenous
Background Doxorubicin Other / unclassified 60 mg/m2 Intravenous
Background Epirubicin Small molecule 90 mg/m2 Intravenous
Background Paclitaxel Small molecule 80 mg/m2 Intravenous

Indications

triple-negative breast carcinoma