Abemaciclib + Elacestrant for Breast Cancer with Brain Metastasis

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byPeter Kabos, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Criterium, Inc.

No Placebo Group

Breakthrough Therapy

Trial Summary

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.

Research Team

Peter Kabos, MD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

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

My organs are functioning well.

I am post-menopausal based on age, surgery, or hormone levels.

I can take pills by mouth.

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Exclusion Criteria

I have not had any cancer other than skin or early cervical cancer in the last 5 years.

I am a woman and have not gone through menopause.

I have no conditions that prevent me from taking pills.

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Treatment Details

Interventions

Abemaciclib (Cyclin-Dependent Kinase Inhibitor)
Elacestrant (Selective Estrogen Receptor Degrader)

Trial OverviewThe study tests a combination of Abemaciclib and Elacestrant in patients whose breast cancer has metastasized to the brain. It's an open-label Phase Ib/II trial allowing prior endocrine therapy use, aiming to assess the effectiveness and safety of this drug combo.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Abemaciclib/ElacestrantExperimental Treatment2 Interventions

Abemaciclib and Elacestrant combination