About this trial
The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. Study participation could last up to 10 years. Eligible patients will be randomly put into one of two treatment groups in this study:
Experimental Arm: Imlunestrant
Active Comparator Arm: Investigator’s Choice of Endocrine Therapy
Patient Profile
Patients (18 years and older) who have previously received 2 to 5 years of adjuvant endocrine therapy for ER+, HER2- early breast cancer and whose breast cancer has an increased risk of recurrence.
Where’s this trial being run?
Beacon Hospital, Beaumont Hospital, Bon Secours Cork, Cork University Hospital, Sligo University Hospital, St James’s Hospital, St Vincents University Hospital, University Hospital Galway, and University Hospital Waterford
Can I join this study / trial?
The first thing you do is to talk to your doctor and/or the cancer trials research team in your hospital. The contact details for the cancer trials research units in Ireland is here.
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Here’s a list of questions you may have for your doctor or local cancer research team.
QuestionsSummary Data
Name: | EMBER-4 |
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Number: | 24-07 |
Full Title: | EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients Who Have Previously Received 2 to 5 Years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer With an Increased Risk of Recurrence. |
Principal Investigator: | |
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Type: | Industry Sponsored |
Sponsor: | Eli Lilly and Company |
Recruitment Started: |
Global: October 2022 Ireland: |
Global Recruitment Target: | 6000 |
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Ireland Recruitment Target: | 244 |