The ELAINE-3 clinical research study is for people who have locally advanced or metastatic ER-positive/HER2-negative breast cancer with an ESR1 mutation. The study will test the efficacy of lasofoxifene (the investigational therapy) with abemaciclib, an approved CDK4/6 inhibitor compared to the combination of fulvestrant with abemaciclib.
Thank you for considering to join the ELAINE-3 study. You may be able to participate in the study if each description in the list below applies to you:
Other study requirements will apply.
Meet Lori, a fictional woman, and read about her story which shows what a potential journey into the ELAINE-3 study may look like
Download Lori's StoryStudy participants can expect the following:
1. Review & sign the Informed Consent Form
Learn about the risks and benefits of participating in a clinical trial and what your rights are as a participant. Your provider will share an Informed Consent Form (ICF), which helps make sure that you have received all the information you need to make a decision about participating in the trial.
2. Screening
To participate in the trial, your breast cancer must express an ESR1 mutation. During the screening process, you will receive a blood test to determine if you have an ESR1 mutation as well as health assessments to confirm if you qualify for the study.
3. Therapy Assignment
lasofoxifene
+
abemaciclib
or
fulvestrant
+
abemaciclib
If you qualify to participate, you will then be randomly assigned to receive a study therapy combination. Half the participants will be assigned to receive lasofoxifene with abemaciclib, and the other half will receive fulvestrant and abemaciclib.
4. Study Treatment period
During the first month of your participation in the study, you will visit the study clinic every 2 weeks. After that, you will visit the clinic once a month until you stop taking the study therapies.
5. Follow-up period
You will receive study health assessments via phone calls after your final study visit.
Participation in a clinical study is voluntary. You can ask any questions you have and may leave the study at any time, for any reason.
