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)

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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 multicenter, Phase 1b/2 trial. The Phase 1b part of the trial aims to determine the RP2D of elacestrant when administered in combination with alpelisib, everolimus, palbociclib, and ribociclib. The Phase 2 part of the trial will evaluate the efficacy and safety of the various combinations in patients with ER+/HER2- advanced/metastatic breast cancer.

Clinical Study Identifier: s22-01101

ClinicalTrials.gov Identifier: NCT05563220

Principal Investigator: Nancy Chan.

Other Investigators: Caitlin Elizabeth Ordonez Ferri, Yelena Novik, Maryann J Kwa, Douglas K Marks, Nina D'Abreo, Marleen I Meyers, Neil Vasan, Shridar Ganesan, Wanqing Iris Zhi, Alana Grace Spadalik, Danielle Seidman, Amanda Marie Buzolich, Anastasiya Apanasyuk, Phyu Phyu Soe, Ruth Oratz, Natalie Jill Klar, Annmarie Johnson-Rowe, Alexander A Hindenburg.

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Perlmutter Cancer Center

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