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

StatusActive, Not Recruiting
PhasePhase 3
Started2023-11-01
View on ClinicalTrials.gov ↗

Amendment history

2026-09-08
minor
Study Status v3
Primary completion confirmed: July 2026 (last estimated October 2027)
Primary completion dateestimated 2027-10→confirmed 2026-07-15
Start date2023-10-16→2023-11-01
2026-03-09
notable
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v2
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 864→confirmed 868
Study sitesdetails revised at 1 of 1 site
2025-04-16
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-10→confirmed 2023-10-16
Study sites0→1
2023-09-21
minor
Original filing
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
Trial Details
NCT Number NCT06057610
Lead Sponsor Jiangsu HengRui Medicine Co., Ltd.
Conditions HER2-PositiveRecurrent or Metastatic Breast Cancer
Enrollment 868 participants
Start Date 2023-11-01
Primary Completion 2026-07-15 (estimated)
Study Completion 2032-10 (estimated)
Updated on ClinicalTrials.gov 2026-09-09