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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About Expanded Access
Expanded Access, or Compassionate Use, is the use of an investigational medicine prior to regulatory approval and outside of an active clinical trial.
Sermonix does not currently have an Expanded Access program for any of our investigational drugs, nor can the company accommodate so-called “Right to Try” requests at this time.
We encourage you to consult with your physician about treatment options that may be right for you.