Abemaciclib + SRS for Breast Cancer Brain Metastases

Palo Alto (17 mi)

Overseen byKamran A Ahmed, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This is a single arm study of abemaciclib and endocrine therapy with stereotactic radiosurgery (SRS) among patients with hormone receptor (HR)+/HER2- metastatic breast cancer brain metastases.

Eligibility Criteria

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.

Inclusion Criteria

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

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

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

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

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

My breast cancer is hormone receptor positive.

I can take pills by mouth.

My breast cancer is not HER2 positive.

My largest brain tumor is 4 cm or smaller.

Exclusion Criteria

I am not pregnant or breastfeeding.

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

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

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

I have received whole brain radiation therapy before.

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

I do not have any active infections.

Treatment Details

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.

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.

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: