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.

Brief description of study

You can participate in this study if you are diagnosed with ER+, HER2- Early Breast Cancer (Stages I-III) with an Increased Risk of Recurrence. And have Previously Received 2 to 5 years of Endocrine Therapy for ER+, HER2. The main purpose of this study is to evaluate how well the study drug (imlunestrant) works compared to the Standard of care endocrine therapy of physician’s choice. The study also assess the Safety, Tolerability, and Efficacy of the study drug. The study is also being done to learn more about how the study drug is absorbed (taken up in the body), metabolized (broken down by the body), distributed (circulated in the body), and eliminated (passed out of the body). The patients will be monitored and taken care of while on this medication during the entire study period.


Clinical Study Identifier: s22-00472
Other Investigators: Yelena Novik, Maryann J Kwa, Jason E Sandler, Marleen I Meyers, Jennifer Wu, Cristian C Papazoglu Statescu, Andrea Popescu-Martinez, Amanda Marie Talmadge, Sylvia Adams, Nina D'Abreo, Danielle Seidman, Anastasiya Apanasyuk, Caitlin Elizabeth Ryan, Theresa Ryan, Alexander A Hindenburg, Ruth Oratz, Natalie Jill Klar, Mary Lynn R Nierodzik, Douglas K Marks.


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