Trial Profile

A Randomized Phase 3, Double-Blind, Placebo-Controlled Study of Elacestrant Plus Everolimus Versus Elacestrant in Patients With ER+/HER2-, ESR1mut Advanced Breast Cancer Progressing to Endocrine Therapy and CDK4/6 Inhibitors

Status: Recruiting

Phase of Trial: Phase III

Latest Information Update: 27 Aug 2026

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At a glance

Drugs Elacestrant (Primary) ; Everolimus (Primary) ; Betamethasone; Leuprorelin; Triptorelin
Indications Advanced breast cancer; HER2 negative breast cancer; Male breast cancer
Focus Registrational; Therapeutic Use
Acronyms ADELA
Sponsors Medica Scientia Innovation Research; Stemline Therapeutics

20 Aug 2026 Planned number of patients changed from 240 to 300.
01 Jun 2026 According to a MEDSIR media release, design of this study were presented at the ASCO 2026 scientific congress, held in Chicago.
25 May 2026 According to a Menarini media release, the data from the trial will be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting.

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