drugset / Trial / NCT05596409

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

NCT05596409

Phase 2 Active not recruiting 61 enrolled Stemline Therapeutics, Inc.
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2023-05-19
Primary completion
2026-11
Completion
2027-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Elacestrant Other / unclassified 400 mg Oral

Indications