A Trial to Evaluate Ovarian Suppression Following Subcutaneous ZOLADEX 10.8 mg in Premenopausal Women With Early-stage and Advanced HR+ Breast Cancer

StatusRecruiting
PhasePhase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 4 months later Nov 30, 2026 → Mar 30, 2027
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from TerSera Therapeutics LLC

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Trial sites expanded: 23 → 26 locations
    • Eligibility criteria expanded, about 68 words
  2. Notable Start date: Aug 30, 2026 to Oct 30, 2026
    • Trial sites expanded: 20 → 23 locations
    v10
  3. Notable Primary endpoint(s) modifiedv9 Show 7 more changesShow less
    • Enrollment increased: 88 → 176 participants
    • Primary completion pushed from Nov 30, 2026 to Mar 30, 2027
    • Study completion pushed from Mar 30, 2027 to Jul 31, 2027
    • Eligibility criteria expanded, about 140 words
    • Secondary endpoints revised (3)
    • Site details revised at 1 of 20 sites
    • Study title expanded, about 1 word
  4. Notable Start date: Jun 30, 2026 to Aug 30, 2026
    • Trial sites expanded: 15 → 20 locations
    v8
  5. Minor Trial sites expanded: 11 → 15 locationsv7
  6. Notable Start date: May 29, 2026 to Jun 30, 2026
    • Study sites: 10 to 11
    v6
  7. Notable Recruitment opened
    • Start date: Apr 29, 2026 to May 29, 2026
    • Trial sites expanded: 3 → 10 locations
    v5
  8. Notable Start date: Feb 27, 2026 to Apr 29, 2026
    • Study sites: 1 to 3
    v4
  9. Minor Study sites: 0 to 1
    • Start date: Jan 29, 2026 to Feb 27, 2026
    v3
  10. Notable Start date: Dec 29, 2025 to Jan 29, 2026v2
  11. Minor Study First Submitted
  • 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.
The primary objective of this trial is to evaluate ovarian suppression following treatment with ZOLADEX 10.8 mg by luteinizing hormone (LH) within each cohort.
Trial Details
NCT Number NCT07310420
Lead Sponsor TerSera Therapeutics LLC
Conditions
(from sponsor)
Advanced Breast Cancer, Early Breast Cancer
Related terms Breast Neoplasms
Enrollment 176 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov