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RECRUITING
NCT06682195
PHASE2

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

Sponsor: First Affiliated Hospital of Zhejiang University

View on ClinicalTrials.gov

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

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.

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