Clinical trial · Interventional
Study of Screening Brain MRIs in Stage IV Breast Cancer
Phase II Study of Screening Brain MRIs in Stage IV Breast Cancer
NCT05115474CI-TRIAL-00111932recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 16, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260916-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
| Hormone Receptor-positive Breast Cancer | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Magnetic Resonance Imaging | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Screening MRI
- description
- 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.
- interventionNames
- Diagnostic Test: Magnetic Resonance Imaging
Primary outcomes (2)
- measure
- Rate of Brain Metastasis
- timeFrame
- at Baseline
- description
- Rate of brain metastasis by breast cancer subtype at baseline using MRI images.
- measure
- Rate of Brain Metastasis
- timeFrame
- up to 6 months
- description
- Rate of brain metastasis by breast cancer subtype at 6 months or first systemic progression using MRI images.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDAhmed 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