A Phase 2 Bridging Study of Elacestrant Monotherapy in Advanced or Metastatic Breast Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzony rozpoznaniem raka piersi, który nie może być operacyjnie usunięty lub nie nadaje się do leczenia promieniowaniem
- •Dla kobiet: stan pomenopauzalny
- •Nowotwór musi być dodatni na receptor estrogenowy (ER+) i ujemny na receptor HER2 (HER2-)
- •Mutacja w genie ESR1 potwierdzona specjalnym testem diagnostycznym
- •Pogorszenie się choroby podczas lub w ciągu 28 dni od zakończenia leczenia inhibitorem CDK4/6 w połączeniu z fulwestrantem lub inhibitorem aromatazy
✗ Disqualifies
- •Poprzednie leczenie elacestrantem lub podobnymi lekami degradującymi receptor estrogenowy
- •Poprzednie leczenie terapią z użyciem przeciwciał sprzężonych z lekami na zaawansowanego raka piersi
- •Radioterapia w ciągu 14 dni (28 dni dla zmian w mózgu) przed rozpoczęciem badania
- •Nieoddalone macica z historią atypowych zmian błony śluzowej macicy
- •Diagnoza innego raka w ciągu ostatnich 5 lat (wyjątkiem są nietypowe nowotwory skóry lub rak szyjki macicy)
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- October 13, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (19)
Chiba Cancer Center
Chiba, Japan
Kyushu University Hospital
Fukuoka, Japan
National Hospital Organization - Kyushu Medical Center
Fukuoka, Japan
Saitama Cancer Center
Ina, Japan
Tokai University Hospital
Isehara, Japan
The Cancer Institute Hospital of JFCR (Japanese Foundation For Cancer Research)
Kōtō City, Japan
Kumamoto Shinto General Hospital
Kumamoto, Japan
Kumamoto University Hospital
Kumamoto, Japan
Nagoya City University Hospital
Nagoya, Japan
National Hospital Organization - Nagoya Medical Center
Nagoya, Japan
National Hospital Organization - Osaka National Hospital
Osaka, Japan
Kindai University Hospital
Sakaishi, Japan
Hokkaido University Hospital
Sapporo, Japan
National Hospital Organization - Hokkaido Cancer Center
Sapporo, Japan
Shizuoka General Hospital
Shizuoka, Japan
Osaka University Hospital
Suita, Japan
Juntendo University Hospital
Tokyo, Japan
Tokyo Medical University Hospital
Tokyo, Japan
Mie University Hospital
Tsu, Japan
Trial contact
Stemline Trials
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/15/2026.
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