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Elacestrant in metastatic breast cancer: Is the “standard of care” meeting standard requirements?

ABSTRACT: Highlights • In randomized controlled trial, the “standard of care” should not be restricted as it may penalize the control arm.• Restricting the control arm can lead to clinically inappropriate situations according to prior and per-protocol treatment.• Trial designs should allow us to answer clinical questions that are directly relevant to real-life practice. The EMERALD trial was an open label phase 3 trial evaluating elacestrant, the first oral selective estrogen receptor degrader (SERD), as compared to “standard of care”, in ER+/HER2- (hormone receptor positive, no HER2 overexpression) advanced or metastatic breast cancer. The EMERALD trial restricted the “standard of care” control arm to limited options that may have led to a substandard control arm. We describe how the EMERALD trial protocol allowed different clinically inappropriate scenarios in the control arm, according to prior therapy. The main relevant question remains the potential advantage of elacestrant over fulvestrant in fulvestrant-naive patients. Analyzing outcomes in subgroups according to prior and per-protocol therapy would help analyzing trial results. However, these subgroup results may be non-significant, and another randomized trial will be needed. Trials should be designed to answer directly clinical questions that are relevant. Graphical abstract Image, graphical abstract

SUBMITTER: Olivier T

PROVIDER: S-EPMC8605291 | biostudies-literature |

REPOSITORIES: biostudies-literature

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