Study of Screening Brain MRIs in Stage IV Breast Cancer
Phase II Study of Screening Brain MRIs in Stage IV Breast Cancer
1 other identifier
observational
170
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2021
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 1, 2021
CompletedFirst Posted
Study publicly available on registry
November 10, 2021
CompletedStudy Start
First participant enrolled
December 21, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 17, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
ExpectedFebruary 9, 2026
February 1, 2026
4.3 years
November 1, 2021
February 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Rate of Brain Metastasis
Rate of brain metastasis by breast cancer subtype at baseline using MRI images.
at Baseline
Rate of Brain Metastasis
Rate of brain metastasis by breast cancer subtype at 6 months or first systemic progression using MRI images.
up to 6 months
Secondary Outcomes (5)
Rate of Asymptomatic Leptomeningeal Disease
Baseline and at up to 6 months
Number of Brain Metastases
Baseline
Overall Survival
Up to 6 months
Number of Participants Requiring Whole Brain Radiation Therapy vs Stereotactic Radiation
Up to 6 months
Brain Metastasis Specific Survival
Up to 6 months
Study Arms (3)
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.
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.
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.
Interventions
Participants will undergo MRI imaging with and without contrast.
Eligibility Criteria
Stage IV breast cancer patients at Moffitt Cancer Center
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Morton Plant Mease- Baycare
Clearwater, Florida, 33756, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Related Publications (1)
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.
PMID: 39851040DERIVED
Related Links
Biospecimen
Blood samples will be collected to evaluate changes in surrogate biomarkers related to brain metastasis progression. Changes in biomarkers such as cytokines associated with T-cell activation and lymphocyte subpopulations may provide evidence of brain metastasis progression. Furthermore, circulating tumor DNA may identify populations of patients more likely to undergo CNS progression
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kamran A Ahmed, MD
Moffitt Cancer Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2021
First Posted
November 10, 2021
Study Start
December 21, 2021
Primary Completion
April 17, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
February 9, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share