Trial Profile

EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients Who Have Previously Received 2 to 5 Years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer With an Increased Risk of Recurrence

Status: Recruiting

Phase of Trial: Phase III

Latest Information Update: 25 May 2025

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At a glance

Drugs Imlunestrant (Primary) ; Anastrozole; Exemestane; Letrozole; Tamoxifen
Indications Early breast cancer; HER2 negative breast cancer; Male breast cancer
Focus Registrational; Therapeutic Use
Acronyms EMBER-4
Sponsors Eli Lilly and Company

25 Feb 2025 Planned number of patients changed from 6000 to 8000.
09 Dec 2024 Planned End Date changed from 15 Mar 2032 to 1 Mar 2032.
09 Dec 2024 Planned primary completion date changed from 15 Oct 2027 to 1 Oct 2027.

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