Oral SERD Trial Outcomes and Combination Safety in HR Positive Breast Cancer

This segment compares patient characteristics, efficacy outcomes, ESR1 mutation handling, and tolerability between EMERALD and EMBER 3 and interprets combination signals from ELEVATE and EvERA to inform potential adoption of imlunestrant. Panelists observe that EMERALD enrolled a more heavily pretreated cohort with near universal prior CDK4/6 exposure and allowed prior chemotherapy, concentrating benefit in patients with ESR1 mutations and durable prior endocrine sensitivity. EMBER 3 used a staged design and included a greater proportion of patients without prior CDK4/6 exposure, which limits direct cross trial comparisons. Combination trials such as ELEVATE and EvERA suggest that pairing oral SERDs with mTOR pathway inhibition can deepen activity but adds overlapping toxicities including stomatitis, fatigue, rash and metabolic changes that require prophylaxis and closer monitoring. Clinicians should weigh prior therapy, biomarker enrichment, expected adverse events and patient quality of life when considering imlunestrant incorporation into treatment sequences. Shared decision making and multidisciplinary support remain essential for individualized implementation broadly.