RecruitingPhase 1Phase 2NCT04588545

Radiation Therapy Followed by Intrathecal Trastuzumab/Pertuzumab in HER2+ Breast Leptomeningeal Disease

Phase I/II Study of Radiation Therapy Followed by Intrathecal Trastuzumab/Pertuzumab in the Management of HER2+ Breast Leptomeningeal Disease


Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

39 participants

Start Date

Dec 10, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to find out if radiation therapy followed by intrathecal trastuzumab and pertuzumab is safe and will result in improved survival in HER2 positive breast cancer which has metastasized to the leptomeninges.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of radiation therapy plus targeted antibody drugs (trastuzumab and pertuzumab) injected directly into the spinal fluid for people with HER2-positive breast cancer that has spread to the membranes surrounding the brain and spinal cord — a condition called leptomeningeal disease. **You may be eligible if...** - You have HER2-positive cancer (a specific protein found on some breast cancer cells) that has spread to the lining of the brain or spinal cord - You have acceptable kidney, liver, and blood counts - Your heart function is adequate (ejection fraction over 50%) - Your overall health and function level meets minimum requirements - You are willing to have a small device (Ommaya reservoir) placed under your scalp to allow drug delivery into the spinal fluid **You may NOT be eligible if...** - You were in another research study within the past 2 weeks - You are currently on certain chemotherapy drugs that can enter the brain (unless your disease progressed while on them) - You have significant lung disease causing shortness of breath at rest - You are pregnant or breastfeeding - You have had a serious reaction to any of the study drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONRadiation Therapy

Participants will receive radiation therapy (RT), either whole brain radiation therapy or focal brain/spine RT. The goal of RT is to palliate symptoms and improve the flow of Intrathecal (IT) therapy through the cerebrospinal fluid (CSF). As such, various RT schedules and targets are permitted. It is expected that the majority of patients will receive WBRT with 30 Gy in 10 fractions. However, shorter fractions of 20 Gy in 5 fractions of WBRT are permitted. In those patients who have more localized leptomeningeal disease in the spine, focal RT in up to 10 fractions may be administered with the exact dose left up to the discretion of the treating radiation oncologist.

DRUGPertuzumab

Participants will be treated at 1 of 4 dose levels of pertuzumab, beginning at 10 mg and increasing up to 80 mg or Maximum Tolerated Dose (MTD).

DRUGTrastuzumab

Participants will be treated at a fixed dose of 80 mg trastuzumab.


Locations(2)

Moffitt Cancer Center

Tampa, Florida, United States

Northwestern University

Evanston, Illinois, United States

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NCT04588545


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