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A Phase 2 Bridging Study of Elacestrant Monotherapy in Advanced or Metastatic Breast Cancer

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Trial sites expanded: 11 → 19 locations
    • Eligibility criteria expanded, about 9 words
  2. Trial sites expanded: 1 → 11 locations
    • Start date changed from estimate of Aug 2026 to Aug 18, 2026
    v3
  3. Re-verified, no change to tracked fieldsv2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a multicenter, open-label, Phase 2 bridging study to evaluate the efficacy and safety of elacestrant in Japanese post-menopausal women and men with estrogen receptor positive (ER+)/human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer with estrogen receptor 1 gene mutation (ESR1-mut) whose disease has relapsed or progressed on at least 1 and no more than 2 prior lines of endocrine therapy for metastatic breast cancer, which must have included cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) therapy in combination with fulvestrant or an aromatase inhibitor.
Trial Details
NCT Number NCT07766018
Lead Sponsor Stemline Therapeutics, Inc.
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov