A Phase 1b/2 Open-Label Umbrella Study to Evaluate Safety and Efficacy of Elacestrant in Various Combinations in Patients with Metastatic Breast Cancer (ELEVATE)

Brief description of study

This is a study that is divided into two phases: Phase 1b and Phase 2. The Phase 1b part will test different combinations of drugs (elacestrant with alpelisib, elacestrant with everolimus, elacestrant with abemaciclib or ribociclib, elacestrant with either palbociclib, abemaciclib, or ribociclib). Patients will receive the drugs for 28 days at different doses. Based on the results, the doses may be adjusted for the next group of patients. In Phase 2, they will use the recommended doses from Phase 1b to test the effectiveness of the combinations. The specific combinations and doses will be determined based on the results from previous groups. The study will include patients who have received previous treatments for their cancer and will evaluate the safety and effectiveness of the different combinations.


Clinical Study Identifier: s22-01101
Other Investigators: Yelena Novik, Maryann J Kwa, Douglas K Marks, Nina D'Abreo, Marleen I Meyers, Amanda Marie Talmadge, Sylvia Adams, Danielle Seidman, Caitlin Elizabeth Ryan, Anastasiya Apanasyuk, Ruth Oratz, Natalie Jill Klar, Alexander A Hindenburg.


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