The ELAINE Study
The ELAINE Study is an open label, randomized, multicenter study evaluating the activity of lasofoxifene relative to fulvestrant for the treatment of postmenopausal women and premenopausal women on ovarian suppression with locally advanced or metastatic estrogen receptor-positive (ER+)/human epidermal growth factor 2-negative (HER2-) breast cancer with an acquired estrogen receptor 1 (ESR1) mutation and who have disease progression on an aromatase inhibitor (Al) in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor.*
The primary objective is to evaluate the progression-free survival (PFS) of 5 mg lasofoxifene relative to fulvestrant for the treatment of postmenopausal women and premenopausal women on ovarian suppression with locally advanced or metastatic ER+/HER2- breast cancer with an ESR1 mutation.
*AIs include Arimidex (anastrozole), Femara (letrozole), or Aromasin (exemestane). CDK 4/6 inhibitors include Kisqali (ribociclib), Ibrance (palbociclib), and Verzenio (abemaciclib).
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