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Neoadjuvant Chemotherapy in Combination With Toripalimab for HR+/HER2- Breast Cancer (NEOTORCH-BREAST01)
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)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)
Official title: Neoadjuvant Chemotherapy Combined With Toripalimab for HR+/HER2- Breast Cancer : a Prospective, Single-arm, Multi-center Study (NEOTORCH-BREAST01)
Key Details
Gender
FEMALE
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2024-06-11
Completion Date
2029-06
Last Updated
2025-08-12
Healthy Volunteers
No
Conditions
Interventions
Neoadjuvant Chemotherapy in Combination with Toripalimab
Epirubicin (or Liposomal Doxorubicin)+Cyclophosphamide, intravenous infusion of 100 mg/m2. Epirubicin (or 35 mg/m2 liposomal doxorubicin)+600 mg/m2 cyclophosphamide, starting from the first day of the week, for a total of 12 weeks. Paclitaxel, administered intravenously at a dose of 260 mg/m2 every 3 weeks for a total of 12 weeks. During neoadjuvant chemotherapy and postoperative adjuvant therapy, use of Toripalimab: intravenous infusion of 240 mg, once every 3 weeks, combined with preoperative neoadjuvant and postoperative adjuvant therapy for a total of 1 year.
HR+ HER2 breast cancer
During neoadjuvant chemotherapy and postoperative adjuvant therapy, use of Toripalimab: intravenous infusion of 240 mg, once every 3 weeks, combined with preoperative neoadjuvant therapy and postoperative adjuvant therapy for a total of 1 year.
Locations (11)
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
Nanchang People's Hospital
Nanchang, China
Zhongshan Hospital, Fudan University
Shanghai, China
Xinjiang Medical University Affiliated Cancer Hospital
Ürümqi, China
Shaanxi Provincial Cancer Hospital
Xi'an, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China