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

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT03807765
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    480 mg intravenous Nivolumab administered every 4 weeks.
  • Stereotactic Radiosurgery — RADIATION
    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.

Study Details

This study is to find out if administration of stereotactic radiosurgery (SRS) given after Nivolumab will improve overall response rate/anti-tumor activity in patients with metastatic breast cancer with brain metastases.

Key Dates

Start date
Jan 30, 2019
Status verified
Dec 2025
Primary completion
Sep 8, 2020
Completion
Mar 18, 2025

Study Design

Enrollment
14 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab followed by stereotactic radiosurgery (SRS)
    480 mg Nivolumab will be given intravenously every 4 weeks, followed by SRS the week after the initial dose of Nivolumab.

Primary Outcome Measure

Number of Participants who experience Dose Limiting Toxicities [ Time Frame: Up to 8 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
H. Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-

Find similar trials in Tampa, FL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
H. Lee Moffitt Cancer Center and Research Institute· Tampa, FL

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