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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
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.

Record History

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  1. Eligibility criteria revised
    • Study title revised
    v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 15, 2024 to Aug 23, 2024
    • Site details revised
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 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.
Trial Details
NCT Number NCT06340230
Lead Sponsor Shengjing Hospital
Collaborators: Jiangsu HengRui Medicine Co., Ltd.
Conditions
(from sponsor)		 HR Positive/HER2 Low Breast Cancer
Enrollment 93 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov