Study on Stereotactic Radiation and Abemaciclib for Managing HR+/HER2- Breast Cancer with Brain Metastases

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04923542

Provider View

This clinical trial is exploring a treatment that combines the drug abemaciclib with targeted radiation therapy for patients with hormone receptor-positive (HR+)/HER2-negative breast cancer that has spread to the brain.

Patient Parameters

Program Overview

The study aims to test the safety and effectiveness of using abemaciclib, a cancer medication, along with stereotactic radiosurgery (a precise form of radiation therapy) in treating brain metastases in patients with HR+/HER2- breast cancer. The treatment starts with a week of abemaciclib, followed by targeted radiation to brain tumors or surgical sites, while continuing abemaciclib. Researchers will monitor safety and adjust radiation doses if unexpected side effects occur. The study will also evaluate how long patients remain free from cancer progression in the brain.

Description

This clinical trial is designed to test a new treatment approach for patients with HR+/HER2- breast cancer that has spread to the brain. The study involves using abemaciclib, a medication that targets cancer cells, in combination with stereotactic radiosurgery (SRS), a type of radiation therapy that precisely targets brain tumors.

The trial is divided into two phases. In the first phase, researchers will focus on ensuring the treatment is safe by starting with a small group of patients and gradually increasing the number. If the treatment is safe, the second phase will evaluate how well it works in preventing cancer from progressing in the brain.

Participants will begin treatment with abemaciclib for one week, followed by SRS to the brain metastases or surgical sites, while continuing to take abemaciclib. The study will closely monitor for any side effects, and adjustments to the radiation dose will be made if necessary. The goal is to determine if this combination can effectively control brain metastases in patients with HR+/HER2- breast cancer.

Eligibility Criteria

Inclusion Criteria

  • Have HR+ breast cancer, meaning the cancer cells have hormone receptors (estrogen or progesterone) as determined by specific medical guidelines.
  • Have HER2- breast cancer, meaning the cancer does not overexpress the HER2 protein.
  • Have 15 or fewer brain metastases that can be treated with stereotactic radiation.
  • Be able to swallow pills.
  • Be willing to follow all study procedures and be available for the study duration.
  • Have measurable brain disease that can be tracked using standard criteria.
  • Be eligible for stereotactic radiosurgery (SRS) to brain metastases or surgical sites.
  • Have a largest brain metastasis no larger than 4 cm.
  • Have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
  • Provide a tumor tissue sample for biomarker evaluation, if possible.
  • Have not previously received SRS or fractioned stereotactic radiotherapy (FSRT) for active measurable disease.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception during and after treatment.
  • Have adequate organ function as defined in the study protocol.

Exclusion Criteria

  • Have leptomeningeal disease (cancer spread to the membranes surrounding the brain and spinal cord).
  • Have previously received whole brain radiation therapy.
  • Have previously taken abemaciclib for brain metastases or in the past 6 months for metastatic disease.
  • Have unresolved side effects from previous cancer treatments, except for certain long-lasting or non-interfering side effects.
  • Be pregnant or breastfeeding.
  • Have serious or uncontrolled medical conditions that would prevent participation, such as severe lung disease, severe kidney impairment, or certain digestive disorders.
  • Have active infections requiring IV antibiotics or detectable viral infections like HIV or active hepatitis B or C.
  • Have a history of certain heart conditions.
  • Have had another cancer within the past 2 years, except for certain low-risk cancers.
  • Have had major surgery or significant injury not recovered from within 14 days before starting the study.
  • Be participating in another clinical trial or have used investigational treatments within 2 weeks of starting the study.
  • Have allergies or hypersensitivity to any study drugs or components.
  • Be a prisoner or involuntarily incarcerated.

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