Clinical Trial

Neoadjuvant Chemotherapy in Combination With Toripalimab for HR+/HER2- Breast Cancer (NEOTORCH-BREAST01)

Recruiting Phase 2
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Record status
This record was last updated August 12, 2025 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.
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)
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-09-23; most recent amendment 2025-08-11.
Trial Details
NCT Number NCT06611813
Lead Sponsor First Affiliated Hospital of Zhejiang University
Conditions HR+/HER2- Breast Cancer
Enrollment 30 participants
Start Date 2024-06-11
Primary Completion 2026-06 (estimated)
Study Completion 2029-06 (estimated)
Updated on ClinicalTrials.gov 2025-08-12