Abemaciclib + Elacestrant for Breast Cancer with Brain Metastasis
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Peter Kabos, MD
Principal Investigator
University of Colorado, Denver
Are You a Good Fit for This Trial?
This trial is for post-menopausal women with HR+/Her2- breast cancer that has spread to the brain. They can have had up to two chemotherapy treatments for advanced disease but must be recovered from major treatment effects. Participants need good organ function, no severe medical conditions, and not be on other investigational drugs. They cannot have used Abemaciclib or Elacestrant before.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive abemaciclib and elacestrant combination therapy, with dose adjustments for toxicity
Safety Analysis
Safety analysis conducted after accrual of first 10 patients to assess treatment emergent adverse events
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Abemaciclib
- Elacestrant
Abemaciclib is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Criterium, Inc.
Lead Sponsor