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
Brief description of study
EMBER-4 is a Phase 3 global, randomized, open-label study of adjuvant imlunestrant vs SOC adjuvant ET of physician’s choice in participants who have previously received 2 to 5 years of standard ET for ER+, HER2- EBC (Stages I-III) with an increased risk of recurrence. Eligible participants must have completed definitive locoregional therapy, received 2 to 5 years of standard adjuvant ET without disease recurrence, and must have an increased risk of recurrence based on clin-path features at diagnosis, as defined in the inclusion criteria (Protocol Section 5.1). Participants may have received (neo) adjuvant chemotherapy and/or targeted therapy with a CDK4/6- or PARP- inhibitor. Participants may not have had a gap of 6 consecutive months during the SOC ET treatment and should not have stopped SOC ET more than 6 months prior to randomization. The study will consist of a 28-day screening phase, followed by a 5-year treatment phase, and a 5-year posttreatment phase, which will include safety, efficacy, and survival follow-up assessments. Physician’s choice ET (tamoxifen or an AI) must be selected and documented for each participant prior to randomization. Participants will be randomized using the following stratification factors: 1. Time from start of initial adjuvant ET to initiation of study treatment (2 to =3 years vs >3 to 5 years) 2. Received prior adjuvant CDK4/6 inhibitor treatment (yes vs no) 3. Nodal status (=N2 vs N1 vs N0)a 4. Menopausal status (pre-/peri-menopausal vs postmenopausal)b 5. Region (North America/Europe vs Asia vs Other)
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