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)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
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.
Nanchang People's Hospital
Nanchang, Jiangxi, China
NOT_YET_RECRUITINGSir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, China
RECRUITINGThe First Affiliated Hospital of Zhejiang University
Hangzhou, China
RECRUITINGZhejiang Cancer Hospital
Hangzhou, China
RECRUITINGHarbin Medical University Cancer Hospital
Harbin, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Anhui Medical University
Hefei, China
RECRUITINGJinhua Municipal Central Hospital
Jinhua, China
RECRUITINGNantong First People's Hospital
Nantong, China
RECRUITINGZhongshan Hospital, Fudan University
Shanghai, China
RECRUITINGShanxi Provincial Cancer Hospital
Shanxi, China
NOT_YET_RECRUITING...and 3 more locations
pathologic complete response(PCR)
The primary study objective is to evaluate the pathologic complete response(PCR) of Neodjuvant treatment of TNBC breast cancer with Toripalimab combined with neoadjuvant chemotherapy and sequential Toripalimab monoclonal antibody
Time frame: 2 years
Event-free survival (EFS)
Time frame: 3 years
radiologic complete response (rCR)
Time frame: 3 years
Objective Response Rate(ORR)
Time frame: 3 years
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