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.

Is This Study For You?

Let's Get Started!

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
Age
Adult
Eligibility
Detailed eligibility criteria is available on clinicaltrials.gov. These requirements will be discussed with your doctor and/or study representative. Click the NCT number link below to learn more about this study on ClinicalTrials.gov
Locations

University of Colorado Hospital

Principal Investigator
Photograph of Peter Kabos

Peter Kabos

Study ID

Protocol Number: 23-0641

More information available at ClinicalTrials.gov: NCT05596409

Categories

Is this Study for You?

Let's Get Started!

Not finding the right Study for you? Join ResearchMatch, a nation-wide registry connecting volunteers and researchers