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

Study acronym: TRACY-1
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoints added 2 → 5 primary endpoints
See other at-risk trials from RayzeBio, Inc.

Record History

  1. Enrollment reopened Enrollment increased: 16 → 64 participants · Eligibility criteria expanded, about 21 words · Site details revised at 31 of 31 sites Show 3 more changesShow less
    • Enrollment increased: 16 → 64 participants
    • Eligibility criteria expanded, about 21 words
    • Site details revised at 31 of 31 sites
  2. Primary endpoint(s) modified Completion pushed from Jan 2033 to Nov 2033 · Interventions: RYZ101 (Drug) to RYZ101 (Drug), Standard of Care Endocrine Therapy (Drug) · Eligibility criteria expanded, about 103 wordsv8 Show 3 more changesShow less
    • Completion pushed from Jan 2033 to Nov 2033
    • Interventions: RYZ101 (Drug) to RYZ101 (Drug), Standard of Care Endocrine Therapy (Drug)
    • Eligibility criteria expanded, about 103 words

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 124 to confirmed 16 · Study sites revised (31)v7 Show 2 more changesShow less
    • Enrollment target: estimated 124 to confirmed 16
    • Study sites revised (31)

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 23 to 31v6
  5. Study Identification, Study Status, Contacts/Locationsv5
Show 3 earlier versionsHide 3 earlier versions
  1. Primary endpoints: 3 to 2 Enrollment target: 172 to 124 · Primary completion date: May 2028 to Oct 2028 · Completion date: Jul 2029 to Jan 2033 · 5 morev4 Show 8 more changesShow less
    • Enrollment target: 172 to 124
    • Primary completion date: May 2028 to Oct 2028
    • Completion date: Jul 2029 to Jan 2033
    • Interventions: Pembrolizumab (Drug), RYZ101 (Drug) to RYZ101 (Drug)
    • Eligibility criteria shortened, about 131 words
    • Site details revised at 3 of 23 sites
    • Study arms: 3 to 2
    • Study title shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 1 to 23v3
  3. Study Identification, Study Status, Oversight, Outcome Measuresv2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
RayzeBio, Inc.
8 trials monitored
See 3 trials at risk
Breast Cancer
5,213 trials monitored
See 271 trials at risk
Phase 1b/2 open-label trial of 225Ac-DOTATATE (RYZ101) in subjects with ER+, HER2-negative unresectable or metastatic breast cancer expressing SSTRs.
Trial Details
NCT Number NCT06590857
Lead Sponsor RayzeBio, Inc.
Conditions Metastatic Breast Cancer, HER2-negative Breast Cancer, ER+ Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer With Bone Involvement, Bone Metastases in Subjects With Advanced Breast Cancer, ER-Positive HER2-Negative Breast Cancer, Estrogen Receptor-positive Breast Cancer +2 more
Enrollment 64 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov