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Neoadjuvant Chemotherapy Combined With Toripalimab for TNBC (NEOTORCH-BREAST02)
Sponsor: First Affiliated Hospital of Zhejiang University
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)
Official title: Neoadjuvant Chemotherapy Combined With Toripalimab for Triple-negative Breast Cancer : a Prospective, Single-arm, Multi-center Study (NEOTORCH-BREAST02)
Key Details
Gender
FEMALE
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
35
Start Date
2024-10-09
Completion Date
2029-10-01
Last Updated
2026-01-14
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (13)
Nanchang People's Hospital
Nanchang, Jiangxi, China
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, China
The First Affiliated Hospital of Zhejiang University
Hangzhou, China
Zhejiang Cancer Hospital
Hangzhou, China
Harbin Medical University Cancer Hospital
Harbin, China
The First Affiliated Hospital of Anhui Medical University
Hefei, China
Jinhua Municipal Central Hospital
Jinhua, China
Nantong First People's Hospital
Nantong, China
Zhongshan Hospital, Fudan University
Shanghai, China
Shanxi Provincial Cancer Hospital
Shanxi, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
Xinjiang Medical University Affiliated Cancer Hospital
Xinjiang, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China