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SHR-A1811 Versus Investigator's Chemotherapy in Recurrent/Metastatic Breast Cancer Clinical Trial

StatusActive, Not Recruiting
PhasePhase 3
Started2023-06-30
View on ClinicalTrials.gov ↗

Amendment history

2026-08-04
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v2
Trial statusRecruiting→Active, Not Recruiting
Primary completion dateestimated 2025-01-30→confirmed 2026-03-20
Completion date2026-06-30→2028-06-30
Enrollment targetestimated 530→confirmed 551
Study sitesdetails revised at 1 of 1 site
2023-07-19
Not Yet Recruiting→Recruiting Study Status, Study Design, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-05-30→confirmed 2023-06-30
Enrollment target528→530
Study sites0→1
2023-04-03
Original filing
The aim of this study was to evaluate whether the progression-free survival of SHR-A1811 was superior to investigator-selected chemotherapy in patients with HER2-low recurrent/metastatic breast cancer. To evaluate whether SHR-A1811 is superior to investigator-selected chemotherapy in patients with HER2-low recurrent/metastatic breast cancer.
Trial Details
NCT Number NCT05814354
Lead Sponsor Jiangsu HengRui Medicine Co., Ltd.
Conditions Breast Cancer
Enrollment 551 participants
Start Date 2023-06-30
Primary Completion 2026-03-20 (estimated)
Study Completion 2028-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-06