ELACESTRANT in Women and Men with CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer: An Open-Label Multicenter Phase 2 Study (ELCIN)
Primary Objective
The purpose of this study is to evaluate the efficacy and safety of elacestrant over the course of 6 months in patients with estrogen receptor positive (ER+)/human epidermal growth factor receptor-2 negative (HER2-) advanced/metastatic breast cancer who received no prior cyclin-dependent kinase targeting enzymes CDK4 and CDK6 inhibitor (CDK4/6i) in the metastatic setting.

Description
This is a Phase 2 trial evaluating the efficacy of elacestrant in patients with ER+/HER2- advanced/metastatic breast cancer who received one or two prior hormonal therapies and no prior CDK4/6i in the metastatic setting. The study duration for each patient is estimated to be: Screening Phase: Up to 28 days prior to Cycle 1, Day 1 (C1D1); Treatment Phase: From C1D1 until the date of radiologically documented progression, or treatment discontinuation due to other reasons. Survival Follow-Up Phase: All patients will be followed for survival approximately every 3 months up to 24 months after enrollment of the last patient. Patients will be followed for adverse events (AEs) for 28 days after the last treatment administration.
Details
Locations
University of Colorado Hospital
Principal Investigator

Peter Kabos
Study ID
Protocol Number: 23-0641
More information available at ClinicalTrials.gov: NCT05596409
Categories
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