drugset / Trial / NCT06682195

Neoadjuvant Chemotherapy Combined With Toripalimab for TNBC (NEOTORCH-BREAST02)

NCT06682195 ↗

Phase 2 Recruiting 35 enrolled First Affiliated Hospital of Zhejiang University
NaSingle-groupOpen-labelTreatment

Summary

This study is a prospective, single arm, multi-center phase II clinical trial. The primary study objective is to evaluate the pathologic complete response(PCR) of Adjuvant treatment of TNBC breast cancer with Toripalimab combined with neoadjuvant chemotherapy, including the incidences and types of adverse events. The secondary study objective is to observe and evaluate the disease-free survival (DFS), Progression-Free-Survival (PFS ),and Objective Response Rate(ORR)

Timeline

Start
2024-10-09
Primary completion
2026-10-01
Completion
2029-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Toripalimab Monoclonal antibody 240 mg Intravenous
Background Albumin-Bound Paclitaxel Unknown 260 mg/m2 Intravenous
Background Cyclophosphamide Other / unclassified 600 mg/m2 Intravenous
Background Epirubicin Small molecule 100 mg/m2 Intravenous