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NCT Number: NCT05115474

Study of Screening Brain MRIs in Stage IV Breast Cancer

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.

Recruiting

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Key information

Conditions

Triple Negative Breast Cancer Breast Diseases Breast Neoplasms HER2-positive Breast Cancer Hormone Receptor-Positive Breast Cancer Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Morton Plant Mease- Baycare, Clearwater, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic Resonance Imaging

Diagnostic Test

Participants will undergo MRI imaging with and without contrast.

Other names: MRI

Primary outcomes

  1. Rate of Brain Metastasis

    Time frame: at Baseline

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

  2. Rate of Brain Metastasis

    Time frame: up to 6 months

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

Secondary outcomes

  1. Rate of Asymptomatic Leptomeningeal Disease

    Time frame: Baseline and at up to 6 months

    Rate of asymptomatic leptomeningeal disease by breast cancer subtype at baseline and at 6 months or first systemic progression, using MRI images.

  2. Number of Brain Metastases

    Time frame: Baseline

    Number of Brain Metastases at Diagnosis by Breast Cancer Subtype, using MRI images.

  3. Overall Survival

    Time frame: Up to 6 months

    Overall Survival (OS) will be measured from the initial on study date to the recorded date of death.

  4. Number of Participants Requiring Whole Brain Radiation Therapy vs Stereotactic Radiation

    Time frame: Up to 6 months

    Number of Participants Requiring Whole Brain Radiation Therapy vs Stereotactic Radiation by breast cancer type.

  5. Brain Metastasis Specific Survival

    Time frame: Up to 6 months

    Brain metastasis specific survival following brain metastasis by breast cancer subtype

Study contacts

Contact information is provided by the study sponsor or research team.

Robin Dowell

CONTACT

[email protected]

813-745-0393

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • Florida Breast Cancer Foundation

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Nov 10, 2021
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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