drugset / Trial / NCT04791384

Phase Ib/II Trial of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to HR+/Her2- Breast Cancer

NCT04791384

Phase 1/2 Terminated 5 enrolled Criterium, Inc.
NaSequentialOpen-labelTreatment

Summary

This is a multi-institutional, single arm, open label, Phase Ib/II study of abemaciclib in combination with elacestrant in patients with HR+/Her2- breast cancer metastatic to the brain. Patients may have received up to two prior lines of systemic chemotherapy for locally advanced or metastatic disease. There will be no limit on prior use of endocrine therapy including aromatase inhibitors, tamoxifen and fulvestrant, given a documented clinical benefit of elacestrant in this setting.

Timeline

Start
2022-04-21
Primary completion
2024-09-16
Completion
2024-09-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Abemaciclib Small molecule 150 mg Oral
Subject Elacestrant Other / unclassified 400 mg Oral

Indications