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Elacestrant in ER+/HER2- Advanced or Metastatic Breast Cancer With ESR1-mutation
NCT07766018Phase 2
Key facts
- Status
- Recruiting
- Start
- Aug 2026
- Primary completion
- Oct 2028
- Countries
- 1
- Sponsor
- Stemline Therapeutics
- Drugs
- elacestrant
- Conditions
- breast cancer
01
Overview
Phase 2, open-label, single-arm trial of elacestrant in breast cancer, sponsored by Stemline Therapeutics. Primary endpoint: Progression-free Survival as Assessed by the Imaging Review Committee at 27 months. Started Aug 2026; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Elacestrant
Participants will receive elacestrant once daily.
03
Who it enrols
Japanese post-menopausal women and men with ER+/HER2- advanced or metastatic breast cancer with ESR1 mutation, who progressed on prior CDK4/6 inhibitor therapy.
04
Endpoints
Primary
Progression-free Survival as Assessed by the Imaging Review Committee
Secondary
Number of Participants with Adverse Events
Plasma Concentration of Elacestrant
Progression-free Survival as Assessed by the Investigator
Overall Survival
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