ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer Study — ELCIN  

Metastatic Breast Cancer Clinical Trial

Official title: 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)

Status Recruiting

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. ;

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

• 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