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NCT07357298 · ClinicalTrials.gov registry record · Phase 3
Phase III Trial of Brain MRI Surveillance in Stage IV Breast Cancer
A Phase 3 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 156
- Enrollment target
NCT07357298: Recruiting Phase 3 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT07357298 is a Phase 3 study that is actively recruiting participants, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 156 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07357298, a Phase 3 study, is actively recruiting participants, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 156 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Proportion of patients receiving surgery or whole-brain radiation therapy for brain metastases.
Interventions
- DIAGNOSTIC_TEST Surveillance Brain MRI
- DIAGNOSTIC_TEST Standard of Care Brain Imaging
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 156 participants |
| Start Date | 2026-02-25 |
| Est. Completion | 2030-02 |
| Phase | Phase 3 |
What NCT07357298 shows while recruiting
NCT07357298 is an interventional study that assigns participants to a tested intervention. The registered 156 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Surveillance Brain MRI is the first listed.
NCT07357298 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07357298 about?
NCT07357298 is a clinical study titled "Phase III Trial of Brain MRI Surveillance in Stage IV Breast Cancer". 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, ...
What is the current status of trial NCT07357298?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 156 participants. The study started on 2026-02-25. Estimated completion is 2030-02.
What interventions are being tested in trial NCT07357298?
The interventions under investigation include: Surveillance Brain MRI (DIAGNOSTIC_TEST), Standard of Care Brain Imaging (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT07357298?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07357298's enrollment target sits among peer trials
156 1506th of 2000 higher than 492 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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