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

StatusRecruiting
PhasePhase 2
Started
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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.

Record History

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  1. Re-verified, no change to tracked fieldsv4
  2. Enrollment target: 50 to 30v3 Show 7 more changesShow less
    • Primary endpoints: 1 to 2
    • Study sites: 8 to 11
    • Primary completion date: Oct 2026 to Jun 2026
    • Study completion date: Oct 2029 to Jun 2029
    • Start date changed from estimate of Oct 2024 to Jun 11, 2024
    • Interventions: Adjuvant treatment combined with Toripalimab (Drug), HR+ HER2 breast cancer (Drug) to HR+ HER2 breast cancer (Drug), Neoadjuvant Chemotherapy in Combination with Toripalimab (Drug)
    • Study description shortened, about 1 word
  3. Study title revisedv2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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)
Trial Details
NCT Number NCT06611813
Lead Sponsor First Affiliated Hospital of Zhejiang University
Conditions
(from sponsor)		 HR+/HER2- Breast Cancer
Related terms Breast Neoplasms
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov