Abemaciclib + Elacestrant for Breast Cancer with Brain Metastasis

Recruiting at 2 trial locations

Overseen By Ruth Stone

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Criterium, Inc.

Must not be taking: Abemaciclib, Elacestrant

Disqualifiers: Pregnancy, Under 18, Serious medical conditions, Infections, Cardiovascular history, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

44 Participants Needed

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive abemaciclib and elacestrant combination therapy, with dose adjustments for toxicity

24 weeks

Regular visits for treatment and monitoring

Safety Analysis

Safety analysis conducted after accrual of first 10 patients to assess treatment emergent adverse events

Ongoing during treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Abemaciclib
• Elacestrant

Trial Overview The 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

Group I: Abemaciclib/Elacestrant Experimental Treatment 2 Interventions

Abemaciclib and Elacestrant combination

Abemaciclib is already approved in United States, European Union for the following indications:

Approved in United States as Verzenio for:

• Hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
• HR+, HER2- node-positive early breast cancer

Approved in European Union as Verzenio for:

• HR+, HER2- advanced or metastatic breast cancer
• HR+, HER2- node-positive early breast cancer

Who Is Running the Clinical Trial?

Criterium, Inc.

Lead Sponsor

Trials

18

Recruited

730+