NCT05596409

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

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: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Stemline Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Elacestrant	Starting dose 400 mg elacestrant dihydrochloride administered orally once daily for an estimated 6 months of treatment.

Timeline

• Start date: 2023-05-19
• Primary completion: 2026-01-01
• Completion: 2027-07-01
• First posted: 2022-10-27
• Last updated: 2025-06-05

Locations

34 sites across 6 countries: United States, Brazil, Bulgaria, Georgia, Mexico, Romania

Regulatory

• FDA-regulated drug study