Clinical Trial

SHR-A1811 Alone or in Combination With Adebrelimab as Neoadjuvant Treatment in HR Positive/HER2 Low Breast Cancer

Recruiting Phase 2
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Record status
This record was last updated December 4, 2024 (before its estimated February 28, 2026 completion). Its status may not reflect the trial's current state.
Summary
This is an open-label, phase II study evaluating the efficacy and safety of SHR-A1811 alone or in combination with Adebrelimab in Stage II-III HR Positive/HER2 Low Breast Cancer. Subjects will receive the neoadjuvant therapy of SHR-A1811 alone or in combination with Adebrelimab 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 2024-03-25; most recent amendment 2024-12-02.
Status change: Not Yet Recruiting → Recruiting 2024-10-08
Trial Details
NCT Number NCT06340230
Lead Sponsor Shengjing Hospital
Collaborators: Jiangsu HengRui Medicine Co., Ltd.
Conditions HR Positive/HER2 Low Breast Cancer
Enrollment 93 participants
Start Date 2024-08-23
Primary Completion 2026-02-28 (estimated)
Study Completion 2031-02-28 (estimated)
Updated on ClinicalTrials.gov 2024-12-04