Imlunestrant for Breast Cancer
(PreEMBER Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how a new medicine, imlunestrant, affects estrogen receptor-positive, HER2-negative breast cancer. Researchers aim to compare this treatment to tamoxifen. The study includes two groups: one will take imlunestrant with or without ovarian suppression, and the other will take it without any ovarian suppression. The trial seeks premenopausal women with this type of breast cancer who can take capsules or tablets. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot be on any exogenous reproductive hormone therapy. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that imlunestrant is generally safe. In earlier studies, patients taking imlunestrant experienced fewer severe side effects compared to those on standard treatments. Specifically, only 17.1% of patients experienced serious side effects with imlunestrant, while 20.7% did with standard treatments, indicating that imlunestrant is well-tolerated.
For those taking imlunestrant with goserelin, studies have not yet provided specific safety data. However, imlunestrant alone has demonstrated a good safety record, with manageable side effects and few patients needing to stop treatment because of them. This suggests that the combination might also be well-tolerated.
Overall, imlunestrant appears to have a manageable safety profile, making it a promising option for those considering joining a clinical trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about imlunestrant because it offers a fresh approach to treating breast cancer. Unlike standard treatments like Tamoxifen, which works by blocking estrogen receptors, imlunestrant is a selective estrogen receptor degrader (SERD), aiming to destroy these receptors altogether. This could potentially lead to more effective cancer control, especially for tumors that have become resistant to other hormone therapies. Additionally, when used in combination with Goserelin, imlunestrant may provide an even more comprehensive blockade of estrogen's effects, offering new hope for better outcomes.
What evidence suggests that this trial's treatments could be effective for breast cancer?
Research shows that imlunestrant may effectively treat estrogen receptor-positive, HER2-negative breast cancer. In this trial, participants may receive imlunestrant alone or with Goserelin. Earlier studies found that patients with ESR1 mutations who took imlunestrant lived an average of 34.5 months, compared to 23.1 months with standard treatments. This indicates that patients lived longer on average with imlunestrant. Additionally, imlunestrant reduced the risk of cancer progression or death by 38% compared to standard treatment. These results suggest that imlunestrant could be a promising option for managing early breast cancer in premenopausal women.12678
Who Is on the Research Team?
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST)
Principal Investigator
Eli Lilly and Company
Are You a Good Fit for This Trial?
This trial is for premenopausal women with a type of early breast cancer that's sensitive to hormones but not affected by the HER2 protein. Participants must be eligible based on specific health criteria, which are not detailed here.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Cohort 1: Participants receive imlunestrant with or without ovarian suppression for up to 29 days. Cohort 2: Participants receive imlunestrant without ovarian suppression for up to 6 months.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Imlunestrant
Trial Overview
The study tests Imlunestrant (LY3484356) alone or combined with Goserelin against Tamoxifen in two groups: one exploring effects on breast cancer cells and another on ovarian function without suppressing ovaries, over different durations.
How Is the Trial Designed?
3
Treatment groups
Active Control
Imlunestrant will be given orally
Imlunestrant will be given orally and Goserelin will be given Subcutaneously (SC)
Tamoxifen will be given orally
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University
Citations
SABCS 2025 News: Updated EMBER-3 Efficacy Results ...
“Imlunestrant monotherapy extended median overall survival by 11.4 months versus endocrine therapy in patients with ESR1-mutated ER+/HER2- ...
Updated data for Lilly's Inluriyo™ (imlunestrant) reinforce ...
In all patients, imlunestrant plus abemaciclib reduced the risk of progression or death by 41% versus imlunestrant alone, demonstrated a ...
Updated Efficacy Results from the phase 3 EMBER-3 trial
In the phase 3 EMBER-3 trial, imlunestrant demonstrated statistically significant and clinically meaningful improvement in PFS compared to ...
4.
oncologynewscentral.com
oncologynewscentral.com/breast-cancer/updated-efficacy-data-bolster-support-for-imlunestrant-in-er-positive-her2-negative-advanced-breast-cancerData Bolster Support for Imlunestrant (Inluriyo) in ER ...
For patients with an ESR1 mutation, the median OS was 34.5 months for imlunestrant compared with 23.1 months for standard of care (hazard ratio, ...
5.
targetedonc.com
targetedonc.com/view/imlunestrant-regimens-sustain-efficacy-benefit-in-er-her2-breast-cancerImlunestrant Regimens Sustain Efficacy Benefit in ER+/ ...
Imlunestrant shows significant progression-free survival benefits in advanced breast cancer, offering a promising treatment option for patients.
Imlunestrant with or without Abemaciclib in Advanced ...
The incidence of grade 3 or higher adverse events was 17.1% with imlunestrant, 20.7% with standard therapy, and 48.6% with imlunestrant– ...
7.
conference-correspondent.com
conference-correspondent.com/highlights/asco/asco-2025-breast-cancer-faculty-commentary/safety-of-imlunestrant-in-er-positive-her2-negative-advanced-breast-cancer-ember-3-trial-resultsSafety of Imlunestrant in ER-Positive, HER2-Negative ...
Overall, imlunestrant demonstrated a favorable safety profile comparable with standard therapy, with manageable AEs and few discontinuations. The safety of ...
A Study of Imlunestrant (LY3484356) in Premenopausal ...
Cohort 1: will help researchers learn how a medicine called imlunestrant (LY3484356) affects a specific type of breast cancer. Some patients ...
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