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ER+/HER2 Advanced Or Metastatic Breast Cancer / Elacestrant · Phase 2 Trial
ClinicalTrials.gov · August 14, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned Phase 2 bridging study evaluating elacestrant monotherapy in Japanese post-menopausal women and men with ER+/HER2− advanced or metastatic breast cancer and ESR1 mutations who have progressed after CDK4/6i-containing endocrine therapy. No results are reported in this registry record; the study is currently recruiting with an estimated follow-up of 27 months.
Phase 2, Interventional, Single Group, Open label, Treatment purpose. ER+/HER2- Advanced or Metastatic Breast Cancer; age from 18 Years. Intervention: Elacestrant. n = 70. 1 site: Japan.
This is a planned Phase 2 bridging study evaluating elacestrant monotherapy in Japanese post-menopausal women and men with ER+/HER2− advanced or metastatic breast cancer and ESR1 mutations who have progressed after CDK4/6i-containing endocrine therapy. No results are reported in this registry record; the study is currently recruiting with an estimated follow-up of 27 months.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
This study is designed to bridge efficacy and safety data for elacestrant in a Japanese population with ESR1-mutant breast cancer resistant to CDK4/6i-containing therapy. Results, when available, may inform regional approval and treatment options for this molecularly defined subset.
Phase 2 bridging study in a population-specific cohort (Japanese patients) with a surrogate primary endpoint (PFS); results not yet reported in this registry record.
As stated by the source record.
Quoted from the source exactly as published.
This study is designed to bridge efficacy and safety data for elacestrant in a Japanese population with ESR1-mutant breast cancer resistant to CDK4/6i-containing therapy. Results, when available, may inform regional approval and treatment options for this molecularly defined subset.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07766018). This is a study registration, not published results. Lead sponsor: Stemline Therapeutics, Inc.. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 70 participants (ESTIMATED). Conditions: ER+/HER2- Advanced or Metastatic Breast Cancer. Interventions: DRUG: Elacestrant. Primary outcome measures: Progression-free Survival as Assessed by the Imaging Review Committee , Up to approximately 27 months. Brief summary: 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.