A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants with Early Breast Cancer (EMBER-4)
Phase 1
Recruiting
- Conditions
- Breast NeoplasmsTherapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2022-501007-28-00
- Lead Sponsor
- Eli Lilly & Co.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 6024
Inclusion Criteria
Have early-stage ER+ HER2- breast cancer, Have already had surgery to treat the breast cancer, Have higher-than-average risk for the breast cancer to come back, Have been taking a drug that blocks the production/action of estrogen for the last two to five years, Be able to walk and able to carry out light work, Have adequate body organ function
Exclusion Criteria
Have breast cancer that is advanced or has spread to another part(s) of the body, Have a serious medical condition (other than this cancer)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of imlunestrant (Arm A) vs SOC adjuvant ET (Arm B), in patients who have received 2 to 5 years of standard ET for ER+, HER2- EBC with an increased risk of recurrence;Secondary Objective: To evaluate the efficacy of Arm A compared to Arm B in terms of DRFS, OS, and IDFS, including second non-breast primary invasive cancers, To assess the safety and tolerability of each treatment arm, To assess the PK of imlunestrant, To describe health-related quality of life of each treatment arm, To describe patient-reported overall AE burden of each treatment arm;Primary end point(s): Invasive Disease-Free Survival (IDFS)
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Distant Recurrence-Free Survival (DRFS);Secondary end point(s):Overall Survival (OS);Secondary end point(s):Pharmacokinetics (PK): Steady State Plasma Concentrations of Imlunestrant;Secondary end point(s):Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) Physical Functioning;Secondary end point(s):Change from Baseline in the EORTC QLQ-C30 Role Functioning;Secondary end point(s):Change from Baseline in the EORTC QLQ-C30 Global QOL;Secondary end point(s):Proportion of Time on Study Treatment with High Overall Adverse Event Burden