Clinical Trials | preEMBER: A Phase 2, Open-label Study Evaluating Imlunestrant in Premenopausal Women with Estrogen Receptor-Positive, HER2-Negative Breast Cancer
preEMBER: A Phase 2, Open-label Study Evaluating Imlunestrant in Premenopausal Women with Estrogen Receptor-Positive, HER2-Negative Breast Cancer
The University of Virginia seeks adults age 18 years and older for a clinical trial. You may be eligible for this trial if you are a premenopausal woman with confirmed early-stage estrogen receptor-positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer. This study aims to learn more about how a medication called imlunestrant (LY3484356) affects breast cancer cells and ovarian function compared with another medication called tamoxifen. This study will evaluate the effects of imlunestrant alone and in combination with ovarian function suppression. If you participate in this study, you will be assigned to one of two cohorts, participants in cohort 1 will be randomized (assigned by chance) to one of three treatment arms: Arm A: Imlunestrant Arm B: Imulnestrant and goserelin Arm C: tamoxifen Participants will receive study treatment in cohort 1 for approximately 29 days. Participants in Cohort 2 will be randomized (assigned by chance) to one of two treatment arms: Am A: imlunestrant Arm B: tamoxifen Participants will receive study treatment in cohort 2 for up to six months. This study will include: blood draws, tumor imaging assessments, tumor tissue collection, questionnaires, and physical examinations. Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance. More information can be found here: https://clinicaltrials.gov/study/NCT07286331