Stereotactic Radiation and Nivolumab in the Management of Metastatic Breast Cancer Brain Metastases

PHASE1CompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

January 30, 2019

Primary Completion Date

September 8, 2020

Study Completion Date

March 18, 2025

Conditions
Metastatic Breast CancerBrain Metastases
Interventions
DRUG

Nivolumab

480 mg intravenous Nivolumab administered every 4 weeks.

RADIATION

Stereotactic Radiosurgery

"Patients will receive single session SRS to intact brain metastases and post-operative cavities.~A linear accelerator (LINAC)-based frameless delivery system will be used to deliver the stereotactic radiation. The lesion will be defined using gadolinium enhanced MRI with 1 mm slices for treatment planning purposes prior to the delivery of radiation. The MRI image will be co-registered and fused with CT imaging. Doses will be prescribed to ensure coverage of at least 95% of the planning target volume (PTV) with the prescription dose. Treatments will be delivered using dynamic conformal arcs or intensity modulated radiotherapy."

Trial Locations (1)

33612

H. Lee Moffitt Cancer Center and Research Institute, Tampa

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER

NCT03807765 - Stereotactic Radiation and Nivolumab in the Management of Metastatic Breast Cancer Brain Metastases | Biotech Hunter | Biotech Hunter