NCT05115474RecruitingPhase 2
Study of Screening Brain MRIs in Stage IV Breast Cancer
Phase II Study of Screening Brain MRIs in Stage IV Breast Cancer
Source: ClinicalTrials.gov · Last updated 15 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 170 (estimated)
- First submitted
- 1 Nov 2021
- Start date
- 21 Dec 2021
- Primary completion date
- 16 Jun 2026
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- NCT number
- NCT05115474
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 170
- From 21 Dec 2021 to the primary completion date, 16 Jun 2026
- 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
- Patients with prior history of non-breast cancer malignancies should have no evidence of disease ≥ 2 years
Other illness
- Indications warranting brain MRI for other neurologic conditions at time of study entry
- Chronic kidney disease stage IV or V or end stage renal disease
Other
- Neurologic symptoms warranting standard screening brain MRI in the judgement of the treating physician at time of enrollment
- Contraindication towards MRI imaging 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 diease having progressed past first line therapy in HR+/HER2- patients
- Radiographic evidence of stage IV extracranial disease in TN and HER2+ patients
- Age ≥ 18
- Life expectancy ≥ 6 months
- Eastern Cooperative Oncology Group performance status 0 to 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. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Morton Plant Mease- Baycare Coordinator of this site? Confirm its status | Clearwater | United States | Recruiting |
| Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.