Clinical Trial

Trial of 225Ac-DOTATATE (RYZ101) in Subjects With ER+, HER2-negative Unresectable or Metastatic Breast Cancer Expressing SSTRs.

Study acronym: TRACY-1
Active, Not Recruiting Phase 1/2
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Summary
Phase 1b/2 open-label trial of 225Ac-DOTATATE (RYZ101) in subjects with ER+, HER2-negative unresectable or metastatic breast cancer expressing SSTRs.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2024-09-10; most recent amendment 2026-03-16.
Status change: Recruiting → Active, Not Recruiting 2026-03-16
Trial Details
NCT Number NCT06590857
Lead Sponsor RayzeBio, Inc.
Conditions Metastatic Breast Cancer, HER2-negative Breast Cancer, ER+ Breast Cancer, Advanced Breast Cancer
Enrollment 16 participants
Start Date 2024-07-19
Primary Completion 2028-10 (estimated)
Study Completion 2033-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-18