The ELAINE 2 Study

The ELAINE-2 Study is an open, label multicenter study evaluating the safety and tolerability of lasofoxifene in combination with the CDK 4/6 inhibitor abemaciclib for the treatment of postmenopausal and premenopausal women on ovarian suppression with locally advanced or metastatic HR+/HER2- breast cancer who have an acquired estrogen receptor 1 (ESR1) mutation.

Eligible patients must have progressed on previous treatment with tamoxifen, an AI and/or fulvestrant either alone or in combination with a CDK 4/6 inhibitor or everolimus.*

You may qualify to participate in the study if you:

• Are pre- or postmenopausal (no vaginal bleeding over the past year)
• Have been diagnosed with locally advanced or metastatic ER+/HER2- breast cancer
• Have been diagnosed with an ESR1 mutation. This may have been detected in previous testing by your doctor and if not, a blood test as part of the study will be done to see if the mutation is present
• Have stable breast cancer metastasis to the brain if you have had no evidence of progression for at least 3 months after completion of radiotherapy
• Had disease progression after taking no more than 2 of the following treatments for metastatic breast cancer: AI and/or fulvestrant as monotherapy or in combination with any CDK 4/6 inhibitor, combination of fulvestrant and alpelisib, Tamoxifen monotherapy, combination of exemestane and everolimus

*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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