Interventional Recruiting Phase 2
NCT05115474 on ClinicalTrials.gov
Study of Screening Brain MRIs in Stage IV Breast Cancer
Official title: Phase II Study of Screening Brain MRIs in Stage IV Breast Cancer
- Sponsor: Moffitt Cancer Center
- Collaborators: Florida Breast Cancer Foundation
- Enrollment: 170 (Estimated)
- Study start: 2021-12-21 (Actual)
- Primary completion: 2026-06-16 (Actual)
- Study completion: 2027-06-01 (Estimated)
- Allocation: N/a
- InterventionModel: Single Group
- Masking: None
- PrimaryPurpose: Screening
Brief Summary
The study is a single arm, nonrandomized phase II prospective study, with the goal of investigating the role of screening brain MRIs in neurologically asymptomatic patients with metastatic breast cancer.
Conditions
- Triple Negative Breast Cancer
- HER2-positive Breast Cancer
- Hormone Receptor-positive Breast Cancer
Intervention / Treatment
- Diagnostic Test: Magnetic Resonance Imaging
Primary Outcome Measures
-
Rate of Brain Metastasis
(at Baseline)
Rate of brain metastasis by breast cancer subtype at baseline using MRI images. -
Rate of Brain Metastasis
(up to 6 months)
Rate of brain metastasis by breast cancer subtype at 6 months or first systemic progression using MRI images.
Countries
United States
Locations and Investigators
-
Morton Plant Mease- Baycare, Clearwater, United States (Recruiting)
- Ronica H. Nanda, MD
- Ronica H. Nanda, MD (Principal Investigator)
- Moffitt Cancer Center, Tampa, United States (Active not recruiting)
Study Officials
- Kamran A Ahmed, MD (Principal Investigator) — Moffitt Cancer Center