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A Study of SHR-A1811 Monotherapy or Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 5, 2024 (before its estimated February 28, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Feb 28, 2024 to Feb 28, 2025v3 Show 4 more changesShow less
    • Enrollment target: 61 to 65
    • Study completion date: Feb 28, 2029 to Feb 28, 2030
    • Study arms: 1 to 2
    • Study title expanded, about 2 words
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date changed from estimate of Nov 30, 2022 to Mar 16, 2023
    • Primary completion date: Nov 30, 2023 to Feb 28, 2024
    • Study completion date: Nov 30, 2028 to Feb 28, 2029
    • Site details revised
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is a phase II trial evaluating the efficacy and safety of SHR-A1811 monotherapy or combined with pyrotinib maleate in Stage II-III HER2-positive breast cancer. Subjects will receive the neoadjuvant therapy of SHR-A1811 monotherapy or combined with pyrotinib for six cycles, and then undergo surgery within 4 weeks after neoadjuvant therapy. Efficacy will be assessed every 2 cycles.
Trial Details
NCT Number NCT05635487
Lead Sponsor Shengjing Hospital
Collaborators: Jiangsu HengRui Medicine Co., Ltd.
Conditions
(from sponsor)		 HER2-positive Breast Cancer
Enrollment 65 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov