drugset
drugset / Trial / NCT06611813

Neoadjuvant Chemotherapy in Combination With Toripalimab for HR+/HER2- Breast Cancer (NEOTORCH-BREAST01)

NCT06611813 ↗

Phase 2 Recruiting 30 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）and RCB0-1 ratio of neodjuvant treatment of HR+/HER2- breast cancer with Toripalimab combined with neoadjuvant chemotherapy and sequential Toripalimab monoclonal antibody, 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
2024-06-11
Primary completion
2026-06
Completion
2029-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 600 mg/m2 Intravenous
Subject Doxorubicin Other / unclassified 35 mg/m2 Intravenous
Subject Epirubicin Small molecule 35 mg/m2 Intravenous
Subject Paclitaxel Small molecule 260 mg/m2 Intravenous
Subject Toripalimab Monoclonal antibody 240 mg Intravenous

Indications

Her2-receptor negative breast cancer