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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

December 10, 2020

Primary Completion Date

August 31, 2026

Study Completion Date

August 31, 2026

Conditions
HER2-positive Breast CancerLeptomeningeal MetastasisLeptomeningeal Disease
Interventions
RADIATION

Radiation 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.

DRUG

Pertuzumab

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).

DRUG

Trastuzumab

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

Trial Locations (2)

33612

RECRUITING

Moffitt Cancer Center, Tampa

60208

RECRUITING

Northwestern University, Evanston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER