The ELAINE-3 study
About the ELAINE-3 study:
Study purpose
The ELAINE-3 study will assess the efficacy, safety, and tolerability of the combination of lasofoxifene and abemaciclib compared with that of fulvestrant and abemaciclib for the treatment of pre- and postmenopausal women and men with locally advanced or metastatic estrogen receptor-positive/human epidermal growth factor 2-negative (ER+/HER2-) breast cancer who have disease progression on an aromatase inhibitor (AI)* in combination with either palbociclib or ribociclib as their first hormonal treatment for metastatic disease and who have an estrogen receptor 1 (ESR1) mutation.1
*AIs include Arimidex® (anastrozole), Femara® (letrozole), or Aromasin® (exemestane). Cyclin-dependent kinase 4/6 inhibitors (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.
Focusing on your quality of life
In addition to assessing efficacy specific to progression-free survival (PFS), data collection will also include patient-reported outcomes (PROs) via the FACT-B (Functional Assessment of Cancer Therapy – Breast) and FACT-ES (Functional Assessment of Cancer Therapy – Endocrine Symptoms) survey tools. These are validated tools that focus on quality-of-life issues for patients who are on endocrine therapy. The PROs will be collected in both treatment arms, as all participants will be on a form of endocrine therapy.1
Lori’s story
Learn about the journey of a potential patient to the ELAINE-3 clinical trial in this fictional story.
Sermonix is proud to announce enrollment into ELAINE-3
ELAINE-3 is a large, randomized, phase 3 study with clinical trial sites across the United States, Europe, Asia-Pacific, Israel, and Canada.
If you are interested in learning more about the study and finding out if you qualify to enroll,
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Reference: 1. Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation (ELAINEIII). ClinicalTrials.gov Identifier: NCT05696626. Updated January 27, 2023. Accessed June 20, 2023. https://classic.clinicaltrials.gov/ct2/show/NCT05696626