---
title: Phase III Trial of Brain MRI Surveillance in Stage IV Breast Cancer
nct_id: NCT07357298
overall_status: NOT_YET_RECRUITING
phase: PHASE3
sponsor: H. Lee Moffitt Cancer Center and Research Institute
study_type: INTERVENTIONAL
primary_condition: Breast Cancer
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07357298.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07357298"
ct_last_update_post_date: 2026-01-22
last_seen_at: "2026-05-12T07:25:22.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Phase III Trial of Brain MRI Surveillance in Stage IV Breast Cancer

**NCT ID:** [NCT07357298](https://clinicaltrials.gov/study/NCT07357298)

## Key Facts

- **Status:** NOT_YET_RECRUITING
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 156
- **Lead Sponsor:** H. Lee Moffitt Cancer Center and Research Institute
- **Collaborators:** Florida Department of Health, Florida Biomedical Research Program - Bankhead Coley
- **Conditions:** Breast Cancer
- **Start Date:** 2026-02
- **Completion Date:** 2030-02
- **CT.gov Last Update:** 2026-01-22

## Brief 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Histologic diagnosis of breast cancer with documentation of ER/PR/HER2 status
* Radiographic evidence of stage IV extracranial disease enrolled within 60 days of diagnosis or starting first line therapy. HR+/HER2- patients may be enrolled within 60 days of starting 2nd line therapy as well.
* HR+ will be defined as ER and/or PR \> 10%. To be classified as HER2+ disease, overexpression of HER2 by either IHC or in-situ hybridization is necessary as defined by the ASCO / CAP Guidelines41. Triple negative will be classified as ER and PR \<10% and HER2-.
* Age ≥ 18
* Life expectancy ≥ 6 months
* Eastern Cooperative Oncology Group performance status ≤ 2
* Patients must be able to understand and the willingness to sign an informed consent for study procedures
* Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria:

* Prior diagnosis or treatment of brain metastases or leptomeningeal disease
* History of other non-breast malignancy requiring treatment with the exception of those with a negligible risk of metastasis or death (e.g., 5-year OS of \> 90%), such as but not limited to, non-melanoma skin cancers, stage I endometrioid uterine cancer, and others at the discretion of the PI
* Neurologic symptoms warranting standard screening brain MRI in the judgement of the treating physician at time of enrollment
* Indications warranting brain MRI for other neurologic conditions at time of study entry (including multiple sclerosis, stroke, traumatic brain injuries, epilepsy, hydrocephalus and pituitary gland disorders)
* Contraindication towards MRI with contrast
* Chronic kidney disease stage IV or V or end stage renal disease (CrCl \<30 ml/min)
```

## Arms

- **Surveillance Brain MRI** (OTHER) — Participants receive a baseline brain MRI followed by surveillance brain MRI every 6 months for 24 months.
- **Standard of Care Brain Imaging** (OTHER) — Participants receive a baseline brain MRI followed by standard-of-care imaging only if neurologic symptoms develop.

## 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.

## Primary Outcomes

- **Treatment Characteristics of Brain Metastases** _(time frame: Up to 24 Months)_ — Proportion of patients receiving surgery or whole-brain radiation therapy for brain metastases.

## Secondary Outcomes

- **Frequency of Brain Metastases** _(time frame: Up to 24 Months)_
- **Leptomeningeal Disease Incidence** _(time frame: Up to 24 Months)_
- **Brain Metastases at Diagnosis** _(time frame: Up to 24 Months)_
- **Size of Largest Brain Metastasis** _(time frame: Up to 24 Months)_
- **Overall Survival After Brain Metastasis Diagnosis** _(time frame: Up to 48 Months)_
- **Brain Metastasis Specific Survival** _(time frame: Up to 48 Months)_

## Locations (2)

- Baptist Health South Florida, Miami, Florida, United States
- Moffitt Cancer Center, Tampa, Florida, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.baptist health south florida|miami|florida|united states` — added _(2026-05-12)_
- `locations.moffitt cancer center|tampa|florida|united states` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT07357298*  
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