Clinical Trial

A Phase III Study of SHR-A1811 Injection With or Without Pertuzumab in HER2-Positive Recurrent or Metastatic Breast Cancer

Active, Not Recruiting Phase 3
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Summary
To evaluate the efficacy and safety of SHR-A1811 with or without pertuzumab versus trastuzumab, pertuzumab and docetaxel in HER2-Positive Recurrent or Metastatic Breast Cancer
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-09-21; most recent amendment 2026-03-09.
Status change: Recruiting → Active, Not Recruiting 2026-03-09
Status change: Not Yet Recruiting → Recruiting 2025-04-16
Trial Details
NCT Number NCT06057610
Lead Sponsor Jiangsu HengRui Medicine Co., Ltd.
Conditions HER2-PositiveRecurrent or Metastatic Breast Cancer
Enrollment 868 participants
Start Date 2023-10-16
Primary Completion 2027-10 (estimated)
Study Completion 2032-10 (estimated)
Updated on ClinicalTrials.gov 2026-03-11