What are the ELAINE studies?
The ELAINE studies are evaluating an investigational oral drug, lasofoxifene, in patients with locally advanced or metastatic estrogen receptor-positive/human epidermal growth factor 2-negative (ER+/HER2-) breast cancer expressing an ESR1 mutation(s).
The ELAINE-1 study, found here and the ELAINE-2 study, found here on ClinicalTrials.gov are active, with enrollment complete.
Each participant had disease progression on previous hormonal treatment with an aromatase inhibitor (AI) in combination with a cyclin-dependent kinase 4/6 inhibitor (CDK 4/6 inhibitor).*
Plans for the ELAINE-3 study are underway.
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Who is Elaine?
Coming in 2023/2024: The ELAINE-3 study
With the ELAINE-1 and ELAINE-2 studies complete, Sermonix plans to conduct ELAINE-3: a larger, randomized phase 3 study at clinical trial sites across the United States, Europe, Japan, Israel, and Canada.
The ELAINE-3 study design will compare the combination of lasofoxifene and abemaciclib to the combination of fulvestrant and abemaciclib in adults with ER+/HER2- metastatic breast cancer expressing an ESR1 mutation(s).
The ELAINE-3 study is now posted here on ClinicalTrials.gov.
Please check back for more information about the ELAINE-3 study, including clinical site locations.
About the ELAINE-1 study
The ELAINE-1 study, now complete, evaluated an investigational oral drug, lasofoxifene in women with locally advanced or metastatic ER+/HER2- breast cancer. Each participant showed progression on previous treatment with an Al in combination with a CDK 4/6 inhibitor.* All study participants had an ESR1 mutation.1
Primary Objective:
Evaluated the impact on progression-free survival (PFS) of 5 mg of oral lasofoxifene versus injectable fulvestrant, a treatment commonly used in this population.1
102 total patients
were enrolled in ELAINE-1 at renowned academic institutions including Mayo Clinic, leading cancer centers, and additional trial sites in the United States, Canada, and Israel.1
*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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Estrogen receptor mutations have been found in up to 40% of women who progress on endocrine therapy and may produce resistance to other hormonal treatments. This resistance may negatively impact prognosis.2
The ELAINE-1 study was the first to select all study participants prospectively based on ESR1 mutation status. Identifying these patients was achieved using next-generation sequencing (NGS) testing. NGS testing has demonstrated analytical validity to identify ESR1 mutations on patient plasma.3
Ask your physician about NGS testing for the ESR1 mutation.
About the ELAINE-2 study
Primary Objective:
A second study, ELAINE-2, studied the safety and efficacy of the combination of lasofoxifene and abemaciclib.4
Proudly partnering with Lilly® and Verzenio®
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References: 1. Evaluation of Lasofoxifene Versus Fulvestrant in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation. ClinicalTrials.gov identifier: NCT03781063. Updated August 26, 2021. Accessed July 20, 2022. https://clinicaltrials.gov/ct2/show/NCT03781063 2. Cogliati V, Capici S, Pepe FF, et al. Life (Basel). 2022;12(3):378. 3. Angus L, Beije N, Jager A, Martens JW, Sleijfer S. Cancer Treat Rev. 2017;52:33-40. 4. Evaluation of Lasofoxifene Combined With Abemaciclib in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation. ClinicalTrials.gov identifier: NCT04432454. Updated June 7, 2022. Accessed July 20, 2022. https://clinicaltrials.gov/ct2/show/NCT04432454