Emerald Trial Study Design Strengths and Limitations

The EMERALD trial, which evaluated an oral selective estrogen receptor degrader (SERD) versus standard-of-care endocrine therapies, features several notable design strengths. Its randomized, phase 3 structure and inclusion of patients previously treated with CDK4/6 inhibitors enhance the relevance to current clinical practice. Mandatory baseline genomic testing, including ESR1 mutation assessment, allowed for meaningful subgroup analyses and helped clarify which patients derive the greatest benefit. The trial also used well-defined endpoints such as progression-free survival, improving comparability with other studies. One limitation was that standard-of-care comparators varied by physician choice, introducing potential variability in outcomes. Despite this limitation, EMERALD provides valuable evidence guiding endocrine therapy selection in resistant ER+/HER2- metastatic disease.