Stereotactic Radiosurgery With Abemaciclib, Ribociclib, or Palbociclib in Treating Patients With Hormone Receptor Positive Breast Cancer With Brain Metastases

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byJim Zhong

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Emory University

No Placebo Group

Breakthrough Therapy

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase I trial studies the side effects of stereotactic radiosurgery with abemaciclib, ribociclib, or palbociclib in treating patients with hormone receptor positive breast cancer that has spread to the brain (brain metasteses). Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Abemaciclib, ribociclib, and palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving abemaciclib, ribociclib, or palbociclib concurrently with stereotactic radiosurgery may reduce the side effects and/or increase the response to each of the therapies.

Research Team

Jim Zhong

Principal Investigator

Emory University

Eligibility Criteria

Inclusion Criteria

Pathologic diagnosis of hormone receptor positive (estrogen receptor >= 1 percent or progesterone receptor >= 1 percent) with HER2 negative status, past treatment, or systemic disease status with current clinical diagnosis of up to 10 brain metastases based on contrast-enhanced magnetic resonance imaging (MRI) of the brain

Plan to start or currently receiving an Food and Drug Administration (FDA)-approved CDK4/6 inhibitor (CDKi), which must be started no later than 2 weeks prior to planned radiosurgery with plan to continue CDKi following radiosurgery

Up to 10 brain metastases =< 3 centimeters in greatest dimension, measured on radiation planning MRI

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Treatment Details

Interventions

Abemaciclib (CDK4/6 Inhibitor)
Palbociclib (CDK4/6 Inhibitor)
Ribociclib (CDK4/6 Inhibitor)
Stereotactic Radiosurgery (Radiation)

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Treatment (ribociclib)Experimental Treatment2 Interventions

Beginning within 2 weeks prior to stereotactic radiosurgery, patients receive ribociclib PO QD on days 1-21. Treatment continues in the absence of disease progression or unacceptable toxicity.

Group II: Treatment (palbociclib)Experimental Treatment2 Interventions

Beginning within 2 weeks prior to stereotactic radiosurgery, patients receive palbociclib PO QD on days 1-21. Treatment continues in the absence of disease progression or unacceptable toxicity.

Group III: Treatment (abemaciclib)Experimental Treatment2 Interventions

Beginning within 2 weeks prior to stereotactic radiosurgery, patients receive abemaciclib PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.

Stereotactic Radiosurgery is already approved in Canada, Japan, China, Switzerland for the following indications: