Phase III Trial of Brain MRI Surveillance in Stage IV Breast Cancer

Part of paid clinical trials in Miami, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT07357298
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Surveillance Brain MRI — DIAGNOSTIC_TEST
    Routine scheduled MRI imaging at baseline and at 6-month intervals.
  • Standard of Care Brain Imaging — DIAGNOSTIC_TEST
    Imaging performed only when clinically indicated.

Study Details

This randomized, multi-institutional phase III trial evaluates whether routine surveillance brain MRI every 6 months improves detection and treatment characteristics of brain metastases in neurologically asymptomatic patients with stage IV breast cancer. Patients are stratified by receptor subtype, age, prior therapy, and study site, then randomized 1:1 to either scheduled surveillance MRIs or standard-of-care symptom-triggered imaging. The study aims to determine whether earlier detection leads to differences in treatment modality, frequency of brain metastases, leptomeningeal disease incidence, quality of life, and survival outcomes.

Key Dates

Start date
Feb 25, 2026
Status verified
May 2026
Primary completion
Feb 28, 2030
Completion
Feb 28, 2030

Study Design

Enrollment
156 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Other: Surveillance Brain MRI
    Participants receive a baseline brain MRI followed by surveillance brain MRI every 6 months for 24 months.
  • Other: Standard of Care Brain Imaging
    Participants receive a baseline brain MRI followed by standard-of-care imaging only if neurologic symptoms develop.

Primary Outcome Measure

Treatment Characteristics of Brain Metastases [ Time Frame: Up to 24 Months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Baptist Health South FloridaMiamiFlorida33176
Rupesh Kotecha, MD (PRINCIPAL_INVESTIGATOR)
Reshma Mahtani, MD (PRINCIPAL_INVESTIGATOR)
Moffitt Cancer CenterTampaFlorida33612
Kamran Ahmed, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Miami, FL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Baptist Health South Florida· Miami, FLMoffitt Cancer Center· Tampa, FL

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