What are the ELAINE studies?

The ELAINE studies are evaluating an investigational oral drug, lasofoxifene, in women with locally advanced or metastatic estrogen receptor-positive/human epidermal growth factor 2-negative (ER+/HER2-) breast cancer with an ESR1 mutation.

The ELAINE-1 study, found here and the ELAINE-2 study, found here on ClinicalTrials.gov are 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.

*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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Who is Elaine?

The ELAINE studies are dedicated in memory of Elaine Davidson Nemzer, MD, the sister of Sermonix co-founder Miriam Davidson Portman, MD. Elaine was a brilliant and compassionate child psychiatrist whose life was cut short by metastatic breast cancer at the age of 47. She was the author of several textbook chapters on psychiatry and a dedicated therapist, teacher, colleague, wife, mother, sister, and friend. Even during her illness, she was a source of comfort and hope to all those she encountered, and her spirit continues to serve as an inspiration to the Sermonix team, filling us with passion and purpose.

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 with an ESR1 mutation.

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).
All product names, trademarks, and registered trademarks are property of their respective owners.

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®

Sermonix Pharmaceuticals and associated logos are trademarks of Sermonix Pharmaceuticals. All other trademarks are property of their respective owners.

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

Keep me posted on the ELAINE studies.