NCT06682195

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

Neoadjuvant Chemotherapy Combined With Toripalimab for Triple-negative Breast Cancer : a Prospective, Single-arm, Multi-center Study (NEOTORCH-BREAST02)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: First Affiliated Hospital of Zhejiang University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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)

Conditions

• TNBC, Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Neoadjuvant chemotherapy combined with Toripalimab	1, Neoadjuvant Chemotherapy Phase Combined with Toripalimab 1. First Phase of Neoadjuvant Chemotherapy: Epirubicin + Cyclophosphamide + Toripalimab. Administered intravenously: 100 mg/m² Epirubicin + 600 mg/m² Cyclophosphamide + 240 mg Toripalimab, every 3 weeks for a total of 6 weeks. 2. Second Phase of Neoadjuvant Chemotherapy: Albumin-bound Paclitaxel + Toripalimab. Administered intravenously: 260 mg/m² Albumin-bound Paclitaxel + 240 mg Toripalimab, every 3 weeks for a total of 6 weeks. 2, Receive Breast Cancer Radical Surgery After 4 Cycles of Neoadjuvant Chemotherapy 3, Postoperative Adjuvant Therapy 1. If pathology indicates pCR: Continue immunotherapy, administering 240 mg Toripalimab intravenously every 3 weeks for a total of 1 year. 2. If pathology indicates non-PCR: Continue postoperative adjuvant chemotherapy combined with Toripalimab. 4, Perform Gene Testing on Biopsy Tissue Before Treatment, and Collect Blood Samples for ctDNA Testing Before and After Treatment.

Timeline

• Start date: 2024-10-09
• Primary completion: 2026-10-01
• Completion: 2029-10-01
• First posted: 2024-11-12
• Last updated: 2026-01-14

Locations

13 sites across 1 country: China