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

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

Trial Details

NCT ID
NCT07766018
Phase
PHASE2
Sponsor
Stemline Therapeutics, Inc.
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Elacestrant
Locations (sample)
  • Isehara, Japan|35.39932,139.31019

Key Eligibility Criteria

  • Must have a histologically or cytologically proven diagnosis of adenocarcinoma of the breast with evidence of either locally advanced disease not a…
  • Female participants must be post-menopausal (as defined by the protocol)
  • Must have ER+ and HER2- tumor status confirmed per local laboratory testing
  • Participants must be ESR1-mutant positive determined via testing with the Guardant360 Companion Diagnostic panel test prior to enrollment

For full eligibility, visit ClinicalTrials.gov.

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