In short
Clinical trials are studying Ly3484356 in breast cancer, including early and advanced disease. These studies aim to evaluate how well it works compared with standard endocrine therapy, and they focus on patients with ER-positive, HER2-negative breast cancer.
Key points
- Clinical trials are studying Ly3484356 in breast cancer, including both advanced and early disease. Both listed studies are Phase 3 trials, which means they compare the study treatment with standard care in large groups of patients. One trial focuses on ER-positive, HER2-negative advanced breast cancer, while the other focuses on early breast cancer with a higher risk of recurrence. The main outcomes are progression-free survival and invasive disease-free survival. The trials are authorised and plan to enroll large numbers of participants.
Clinical trials overview
Ly3484356 is being studied in Phase 3 clinical trials for breast cancer. These studies are testing how Ly3484356 compares with standard endocrine therapy, which is treatment that blocks hormones that can help some breast cancers grow.
The trials focus on people with ER-positive, HER2-negative breast cancer. This means the cancer is driven by estrogen signals and does not have high HER2 levels.
Advanced breast cancer study
NCT04975308, also called EMBER-3, is a study in participants with ER+, HER2- advanced breast cancer. It is an interventional study, which means participants receive assigned treatments so the research team can compare results.
This trial compares imlunestrant with the investigator’s choice of endocrine therapy, which may be fulvestrant or exemestane. It also compares imlunestrant plus abemaciclib with imlunestrant alone.
The main goal is to compare progression-free survival (PFS), which is the time during and after treatment when the cancer does not get worse. The study looks at PFS in the overall group, and also in the group with an ESR1 mutation, which is a change in a gene that can affect hormone-related cancer growth.
Early breast cancer study
Trial 2022-501007-28-00, also called EMBER-4, is studying Ly3484356 in participants with early breast cancer. The study compares Ly3484356 with standard endocrine therapy after people have already received 2 to 5 years of standard endocrine treatment.
The trial is for people with ER+, HER2- early breast cancer who have a higher risk of recurrence, meaning the cancer could come back after treatment. The standard endocrine therapy options in the study include exemestane, anastrozole, tamoxifen, and letrozole.
The main outcome is invasive disease-free survival (IDFS), which measures how long a person stays free from a new or returning invasive cancer.
Main endpoints and what they mean
In NCT04975308, the primary endpoint is investigator-assessed PFS, which means the study doctor checks whether the disease has stayed stable or has worsened. The trial compares Arm A versus Arm B in the full study group, and also in the ESR1-mutation detected group.
The same advanced breast cancer study also compares Arm C, which is Ly3484356 plus abemaciclib, with Arm A, which is Ly3484356 alone. This helps show whether adding another medicine improves outcomes.
In EMBER-4, the primary endpoint is IDFS, which is used to see whether Ly3484356 helps keep early breast cancer from returning or spreading.
Who can participate
The studies are designed for people with ER-positive, HER2-negative breast cancer. One study includes advanced breast cancer, while the other includes early breast cancer with increased risk of recurrence.
EMBER-4 includes people who have already completed 2 to 5 years of standard endocrine therapy, so it is focused on treatment after earlier care. The advanced breast cancer study also includes a subgroup with an ESR1 mutation for a separate analysis.
Trial status and size
Both trials are listed as Authorised, which means they have been approved to proceed in the source data. NCT04975308 plans to enroll 874 participants, while EMBER-4 plans to enroll 8,082 participants.
These are large Phase 3 studies, so they are designed to give stronger evidence about whether Ly3484356 helps compared with standard treatment.