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

PHASE2RecruitingINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

October 9, 2024

Primary Completion Date

October 1, 2026

Study Completion Date

October 1, 2029

Conditions
TNBC, Triple Negative Breast Cancer
Interventions
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."

Trial Locations (13)

Unknown

NOT_YET_RECRUITING

Nanchang People's Hospital, Nanchang

RECRUITING

The First Affiliated Hospital of Anhui Medical University, Anhui

RECRUITING

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou

RECRUITING

The First Affiliated Hospital of Zhejiang University, Hangzhou

RECRUITING

Zhejiang Cancer Hospital, Hangzhou

NOT_YET_RECRUITING

Harbin Medical University Cancer Hospital, Harbin

RECRUITING

Jinhua Municipal Central Hospital, Jinhua

RECRUITING

Nantong First People's Hospital, Nantong

RECRUITING

Zhongshan Hospital, Fudan University, Shanghai

NOT_YET_RECRUITING

Shanxi Provincial Cancer Hospital, Shanxi

NOT_YET_RECRUITING

The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an

NOT_YET_RECRUITING

Xinjiang Medical University Affiliated Cancer Hospital, Xinjiang

RECRUITING

The First Affiliated Hospital of Zhengzhou University, Zhengzhou

All Listed Sponsors
lead

First Affiliated Hospital of Zhejiang University

OTHER