NCT07357298RecruitingPhase 3
Phase III Trial of Brain MRI Surveillance in Stage IV Breast Cancer
Source: ClinicalTrials.gov · Last updated 15 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 156 (estimated)
- First submitted
- 12 Jan 2026
- Start date
- 25 Feb 2026
- Primary completion date
- Feb 2030
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07357298
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 156
- From 25 Feb 2026 to the primary completion date, Feb 2030
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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)
- Chronic kidney disease stage IV or V or end stage renal disease (CrCl \<30 ml/min)
Other
- Neurologic symptoms warranting standard screening brain MRI in the judgement of the treating physician at time of enrollment
- Contraindication towards MRI with contrast
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Baptist Health South Florida Coordinator of this site? Confirm its status | Miami | United States | Not yet recruiting |
| Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.