The ELAINE 3 Study

What is the ELAINE-3 study?

The ELAINE-3 clinical research study is for people who have locally advanced or metastatic ER-positive/HER2-negative breast cancer with an ESR1 mutation. The study will test the efficacy of lasofoxifene (the investigational therapy) with abemaciclib, an approved CDK4/6 inhibitor compared to the combination of fulvestrant with abemaciclib.

Who can join the ELAINE-3 study?

Thank you for considering to join the ELAINE-3 study. You may be able to participate in the study if each description in the list below applies to you:

• Pre- or Post-menopausal woman or man who is 18 years of age or older who has a confirmed diagnosis of locally advanced and/or metastatic ER-positive/HER2-negative breast cancer expressing an ESR1 mutation. If you do not know whether you have an ESR1 mutation, that is okay—you can find out during Screening (the qualification period).
• Progression on an Aromatase Inhibitor (AI) in combination with palbociclib or ribociclib as first hormonal treatment for metastatic disease.
• No history of progression on abemaciclib, fulvestrant or other SERD therapy.

Other study requirements will apply.