Recruiting NCT05115474
Study of Screening Brain MRIs in Stage IV Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Magnetic Resonance Imaging.
- Who it may be relevant to
- Registry conditions: Triple Negative Breast Cancer, HER2-positive Breast Cancer, Hormone Receptor-positive Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Phase II Study of Screening Brain MRIs in Stage IV Breast Cancer
Overview
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.
Interventions
- Diagnostic test Magnetic Resonance Imaging
Participants will undergo MRI imaging with and without contrast.
Primary outcome measures
- Rate of Brain Metastasis [Time frame: at Baseline]
- Rate of Brain Metastasis [Time frame: up to 6 months]
Secondary outcome measures (5)
- Rate of Asymptomatic Leptomeningeal Disease [Time frame: Baseline and at up to 6 months]
- Number of Brain Metastases [Time frame: Baseline]
- Overall Survival [Time frame: Up to 6 months]
- Number of Participants Requiring Whole Brain Radiation Therapy vs Stereotactic Radiation [Time frame: Up to 6 months]
- Brain Metastasis Specific Survival [Time frame: Up to 6 months]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
United States · 2 centers
- Morton Plant Mease- Baycare — Clearwater
- Moffitt Cancer Center — Tampa
Publications
- 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 39851040
Identifiers
NCT: NCT05115474 · MCC-21448