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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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.