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RecruitingInterventionalPhase 2

Phase II Study of Screening Brain MRIs in Stage IV Breast Cancer

NCT ID: NCT05115474Sponsor: H. Lee Moffitt Cancer Center and Research InstituteLast updated: 2026-05-18

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.

Arms & interventions

  • Diagnostic TestMagnetic Resonance Imaging

    Participants will undergo MRI imaging with and without contrast.

Outcome measures

Primary

  • Rate of Brain Metastasis

    Rate of brain metastasis by breast cancer subtype at baseline using MRI images.

    Time frame: at Baseline

  • Rate of Brain Metastasis

    Rate of brain metastasis by breast cancer subtype at 6 months or first systemic progression using MRI images.

    Time frame: up to 6 months

Secondary

  • 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

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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

Study locations (2)

Morton Plant Mease- Baycare

Clearwater, Florida, 33756

Recruiting
Ronica H. Nanda, MD · Contact
Ronica.Nanda@baycare.org
Ronica H. Nanda, MD · Principal Investigator

Moffitt Cancer Center

Tampa, Florida, 33612

Active Not Recruiting

References

  • 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.(PubMed)
Study of Screening Brain MRIs in Stage IV Breast Cancer | Cancerify