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Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of elacestrant over the course of 6 months in patients with ER+/HER2- advanced/metastatic breast cancer who received no prior CDK4/6i in the metastatic setting.


Clinical Trial Description

This is a Phase 2 trial evaluating the efficacy of elacestrant in patients with estrogen receptor positive (ER+)/human epidermal growth factor receptor-2 negative (HER2-) advanced/metastatic breast cancer who received one or two prior hormonal therapies and no prior cyclin-dependent kinase targeting enzymes CDK4 and CDK6 inhibitor (CDK4/6i) in the metastatic setting. The study duration for each patient is estimated to be: - Screening Phase: Up to 21 days prior to Cycle 1, Day 1 (C1/D1); - Treatment Phase: From C1/D1 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 AEs for 28 days after the last treatment administration. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05596409
Study type Interventional
Source Stemline Therapeutics, Inc.
Contact Stemline Trials
Phone 877-332-7961
Email clinicaltrials@menarinistemline.com
Status Recruiting
Phase Phase 2
Start date May 19, 2023
Completion date August 2025

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