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CDK4/6 Inhibitor

Abemaciclib + SRS for Breast Cancer Brain Metastases

Phase 1 & 2

Recruiting

Led By Kamran A Ahmed, MD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group performance status 0 to 2

Measurable brain disease per RANO-BM criteria that can be measured in at least one dimension as ≥ 0.5 cm for both intact brain metastases and post-operative cavities

Must not have

Women who are pregnant or breastfeeding

Personal history of syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin, or sudden cardiac arrest

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if adding abemaciclib to endocrine therapy and SRS improves outcomes for patients with HR+/HER2- metastatic breast cancer brain metastases.

Who is the study for?

This trial is for individuals with HR+/HER2- metastatic breast cancer brain metastases. Participants can have had prior radiation treatments if there's measurable disease not previously treated with radiation. They must be able to undergo stereotactic radiosurgery, have ≤ 15 brain lesions eligible for this treatment, and a performance status of 0 to 2. Women must test negative for pregnancy and agree to use contraception.

What is being tested?

The study tests the combination of abemaciclib and endocrine therapy alongside stereotactic radiosurgery (SRS) in patients with specific breast cancer that has spread to the brain. It's a single-arm study, meaning all participants receive the same treatment without comparison groups.

What are the potential side effects?

Potential side effects include fatigue, diarrhea, low blood cell counts leading to increased infection risk or bleeding problems, liver issues indicated by abnormal blood tests, deep vein thrombosis or pulmonary embolism risks due to blood clots.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than half of my waking hours.

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I have a brain tumor or cavity from surgery that can be measured and is at least 0.5 cm big.

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I can provide a tissue sample from my tumor for testing.

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I am a candidate for targeted radiation to my brain or the area where my brain tumor was removed.

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I have 15 or fewer brain tumors suitable for targeted radiation.

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My breast cancer is hormone receptor positive.

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I can take pills by mouth.

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My breast cancer is not HER2 positive.

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My largest brain tumor is 4 cm or smaller.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or breastfeeding.

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I have had fainting spells, irregular heartbeats, or sudden cardiac arrest due to heart issues.

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I am not allergic to any of the drugs or their components used in this study.

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My cancer has spread to the lining of my brain and spinal cord.

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I have received whole brain radiation therapy before.

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I have not taken abemaciclib for brain metastases or in the past 6 months for metastatic disease.

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I do not have any active infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Intracranial Progression Free Survival (PFS)

Secondary study objectives

Extracranial Progression Free Survival

Intracranial distant brain tumor control

Intracranial local brain tumor control

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase 2: Radiation Therapy and AbemaciclibExperimental Treatment3 Interventions

Treatment will be initiated with one week of abemaciclib followed by stereotactic radiation at the phase 1 dose to sites of brain metastases or post-operative cavities with continued abemaciclib.

Group II: Phase 1: Radiation Therapy and AbemaciclibExperimental Treatment3 Interventions

Treatment will be initiated with one week of abemaciclib followed by stereotactic radiation to sites of brain metastases or post-operative cavities with continued abemaciclib. In the phase I portion, safety will be monitored initially by a 3+3 design. If unexpected neurologic toxicities are noted, the dose of radiation therapy will be modified.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Endocrine therapy

2019

Completed Phase 3

~35530

Stereotactic Radiosurgery (SRS)

2012

Completed Phase 2

~280