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ADAPTela: Elacestrant vs Standard Endocrine Treatment in High-risk ER+/HER2- Early Breast Cancer
NCT07242352Phase 3
Key facts
- Status
- Recruiting
- Start
- Apr 2026
- Primary completion
- Sep 2033
- Countries
- 1
- Sponsor
- Women's Cancer Study Group
- Modality
- Molecular Glues
- Drugs
- elacestrant
- Conditions
- breast cancer
01
Overview
Phase 3, randomised trial in breast cancer comparing Elacestrant upfront (ELA) with Standard-of-care endocrine treatment (SoC-ET) (2 arms). Primary endpoint: Invasive Disease-Free Survival at 5 years. Started Apr 2026; status: recruiting.
02
Design
2 arms- Study design
- Randomized
Elacestrant upfront (ELA)
Elacestrant for 5 years +/- ribociclib for 3 years
Standard-of-care endocrine treatment (SoC-ET)
SoC ET for 5-10 years +/- CDK4/6 inhibitors
03
Who it enrols
Patients >= 18 years with HR+/HER2- early breast cancer, high genomic/clinical risk, completed 2-6 weeks of endocrine induction treatment, no distant metastasis, and adequate organ function.
04
Endpoints
Primary
Invasive Disease-Free Survival
Secondary
Distant Disease-Free Survival
Relapse-Free Survival
DCIS Disease-Free Survival
Invasive Breast Cancer-Free Survival
Locoregional Relapse-Free Survival
Overall Survival
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