ELAINE III Trial for Metastatic Breast Cancer
Updated on September 15, 2024
Overview: The ELAINE iII study (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) is designed to see if the combination of lasofoxifene and Verzenio (chemical name: abemaciclib) works better than the combination of Faslodex (chemical name: fulvestrant) and Verzenio against locally advanced or metastatic estrogen receptor-positive, HER2-negative breast cancer with an ESR1 mutation that has grown during treatment with Kisqali (chemical name: ribociclib) or Ibrance (chemical name: palbociclib).
Verzenio, Kisqali, and Ibrance are CDK4/6 inhibitors.
Phase: Phase III; Phase III trials compare the safety and effectiveness of a new treatment to the current standard of care. Phase III trials are usually large – some involve thousands of people – and are done at many places in the United States and around the world.
Number of people to enroll: 400
Clinical trial ID number: NCT05696626
Sponsor of the trial: Sermonix Pharmaceuticals Inc.
Who is the trial for?
The ELAINE III trial is for people diagnosed with locally advanced or metastatic estrogen receptor-positive, HER2-negative breast cancer with an ESR1 mutation that grew while being treated with either Kisqali or Ibrance.
Why is the trial being done?
Research shows that breast cancers that develop an ESR1 mutation can become resistant to hormonal therapy medicines.
This study is designed to see if combining the experimental medicine lasofoxifene with Verzenio leads to better outcomes than the combination of Faslodex and Verzenio for locally advanced or metastatic estrogen receptor-positive, HER2-negative breast cancer with an ESR1 mutation that has grown during treatment with either Kisqali or Ibrance.
In the study, people will take either:
one lasofoxifene pill and two Verzenio pills per day
two Verzenio pills per day, plus Faslodex injections on days 1, 15, and 29 and then once a month after that
The people continue to receive the medicines until the cancer grows or they develop problematic side effects.
Specific eligibility requirements
People are eligible for the ELAINE III study if:
they have been diagnosed with locally advanced or metastatic estrogen receptor-positive, HER2-negative breast cancer that has grown while being treated with an aromatase inhibitor combined with either Ibrance or Kisqali as the first treatment for the advanced-stage disease
the breast cancer has an ESR1 mutation
People are not eligible for the ELAINE III study if they:
developed serious lung problems while receiving previous breast cancer treatments
had the breast cancer grow while receiving Verzenio, Faslodex, or another selective estrogen receptor down-regulator (SERD), such as Orserdu
have a history of blood clots
Read the detailed eligibility requirements.
Side effects
In previous studies, the most common side effects of lasofoxifene included:
higher risk of blood clots
vaginal bleeding
Visit the Faslodex and Verzenio pages to read about their side effects.
In one previous study, ELAINE 2, the side effects caused by the combination of lasofoxifene and Verzenio included:
high creatinine levels; high creatinine levels can mean your kidneys aren’t working properly
Study locations
The study is being conducted in multiple locations in the United States and around the world, including sites in Australia, Europe, Canada, and Asia.
For a complete list of sites, visit: https://clinicaltrials.gov/study/NCT05696626#contacts-and-locations
For more information or to enroll
Call Sermonix Pharmaceuticals Study Inquiry at 614-864-4919 or email info@sermonixpharma.com.