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Radiation Therapy Followed by Intrathecal Trastuzumab/Pertuzumab in HER2+ Breast Leptomeningeal Disease | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

NCT04588545•H. Lee Moffitt Cancer Center and Research Institute

View on ClinicalTrials.gov

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.

Detailed Description

The study is designed as a prospective, single-arm, nonrandomized, open-label, phase I/II trial of radiation therapy (RT) followed by intrathecal (IT) trastuzumab/pertuzumab in the management of HER2+ breast leptomeningeal disease (LMD). Treatment will be initiated with RT, whole brain RT (WBRT) and/or focal brain/spine RT followed by IT trastuzumab/pertuzumab.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Confirmation of HER2 positivity. All patients with HER2+ cancers will be allowed to enroll if they have leptomeningeal disease (LMD). Patients may be IHC 3+ and/or FISH-positive. IHC 2+ HER2 patients are eligible with reflex FISH-positive testing with the ratio ≥2.0.
•And/or patients with HER2 positive cells in the cerebral spinal fluid.
•Participants may have concomitant brain metastases
•Cerebrospinal fluid (CSF) sampling is required to document LMD if not documented by MRI. Participants are still eligible CSF is negative but LMD disease is documented on MRI
•Life expectancy greater than 8 weeks
•Consent to pretreatment tumor biopsy or retrieval of archival tissue
•Normal renal (creatinine \<1.5 × upper limit of normal \[ULN\]), liver (bilirubin \< 1.5 × ULN, transaminases \<3.0 × ULN, except in known hepatic disease, wherein may be \<5 × ULN) and blood counts (white blood cells ≥2.5, neutrophils ≥1000, platelets ≥75,000, hemoglobin ≥8)
•LVEF \>50%
•KPS \>/= 60
•Patients with surgery within 14 days should have recovered from all effects of the surgery and be cleared by their surgeon
+5 more criteria

Exclusion Criteria

•Current or prior participation in a study of an investigational agent or investigational device within 2 weeks of the first dose of study treatment
•Cannot be on systemic agents (chemotherapy) that have Central Nervous System (CNS) penetration (temozolomide, carmustine, lomustine, etoposide, capecitabine, carboplatin, vinorelbine, bevacizumab, irinotecan, and topotecan) unless they develop or have progressive or persistent leptomeningeal metastases while on these agent(s). See protocol for additional information regarding systemic therapies.
•Major surgery or significant traumatic injury that has not been recovered from 14 days before the initiation of study drug
•Symptomatic lung disease resulting in shortness of breath at rest
•Women who are pregnant or breastfeeding
•History of serious adverse event to any of the study drugs or study drug components
•Whole Body Radiation Therapy (WBRT) is not allowed while patients receive IT trastuzumab/pertuzumab; however, focal stereotactic or palliative RT is allowed
•Significant medical or psychiatric illness that would interfere with compliance and ability to tolerate treatment as outlined in the protocol

Locations (2)

Moffitt Cancer Center

Tampa, Florida, United States

Northwestern University

Evanston, Illinois, United States

Key Dates

Start Date

December 10, 2020

Primary Completion Date

August 1, 2026

Completion Date

August 1, 2026

Last Updated

February 9, 2026

Enrollment

ESTIMATED participants

Conditions

HER2-positive Breast CancerLeptomeningeal MetastasisLeptomeningeal Disease

Interventions

Radiation Therapy

RADIATION

Pertuzumab

DRUG

Trastuzumab

DRUG

Contacts

Fiona Roberts, MD

CONTACT

813-745-0630 fiona.roberts@moffitt.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 9, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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