Study of Screening Brain MRIs in Stage IV Breast Cancer
NCT ID: NCT05115474
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
170 participants
OBSERVATIONAL
2021-12-21
2026-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Participants with TNBC (triple negative breast cancer)
Participants will undergo a screening brain MRI. Patients will undergo a second brain MRI at first systemic progression or at 6 months whichever event occurs sooner.
Magnetic Resonance Imaging
Participants will undergo MRI imaging with and without contrast.
Participants with Human Epidermal Growth Factor Receptor 2 (HER2) + Breast Cancer
Participants will undergo a screening brain MRI. Patients will undergo a second brain MRI at first systemic progression or at 6 months whichever event occurs sooner.
Magnetic Resonance Imaging
Participants will undergo MRI imaging with and without contrast.
Participants with Hormone Receptor (HR) +Breast Cancer
Participants will undergo a screening brain MRI. Patients will undergo a second brain MRI at first systemic progression or at 6 months whichever event occurs sooner.
Magnetic Resonance Imaging
Participants will undergo MRI imaging with and without contrast.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Magnetic Resonance Imaging
Participants will undergo MRI imaging with and without contrast.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* Patients with prior history of non-breast cancer malignancies should have no evidence of disease ≥ 2 years
* 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
* Contraindication towards MRI imaging with contrast
* Chronic kidney disease stage IV or V or end stage renal disease
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Florida Breast Cancer Foundation
OTHER
H. Lee Moffitt Cancer Center and Research Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kamran A Ahmed, MD
Role: PRINCIPAL_INVESTIGATOR
Moffitt Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Morton Plant Mease- Baycare
Clearwater, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Ronica H. Nanda, MD
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Ahmed KA, Kim Y, Armaghani AJ, Arrington JA, Costa RL, Czerniecki BJ, Diaz R, Dowell RA, Extermann M, Forsyth PA, Lee KT, Loftus L, Mills MN, Phuoc VH, Rosa M, Soliman HH, Sam CS, Washington IR, Soyano AE, Han HS. Phase II trial of brain MRI surveillance in stage IV breast cancer. Neuro Oncol. 2025 Jul 30;27(6):1550-1558. doi: 10.1093/neuonc/noaf018.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MCC-21448
Identifier Type: -
Identifier Source: org_study_id