Clinical Trial

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

Recruiting Phase 2
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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.
Summary
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2022-12-01; most recent amendment 2024-07-03.
Status change: Not Yet Recruiting → Recruiting 2023-03-18
Trial Details
NCT Number NCT05635487
Lead Sponsor Shengjing Hospital
Collaborators: Jiangsu HengRui Medicine Co., Ltd.
Conditions HER2-positive Breast Cancer
Enrollment 65 participants
Start Date 2023-03-16
Primary Completion 2025-02-28 (estimated)
Study Completion 2030-02-28 (estimated)
Updated on ClinicalTrials.gov 2024-07-05