Screening brain MRIs for patients with stage IV breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the effectiveness of screening brain MRIs in neurologically asymptomatic patients diagnosed with stage IV breast cancer. It focuses on patients with various subtypes of breast cancer, including triple-negative, HER2-positive, and hormone receptor-positive types. The study aims to determine if routine MRI screenings can provide valuable insights into the progression of the disease in these patients. Participants will undergo MRI scans to assess any potential brain metastases that may not yet present symptoms.

Why it matters

Who can join: the full rules

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

Where it's running

• Morton Plant Mease- Baycare
  Clearwater, Florida, United States Recruiting
• Moffitt Cancer Center
  Tampa, Florida, United States Active not recruiting

Study contacts

• Principal investigator: Kamran A Ahmed, MD — Moffitt Cancer Center
• Study coordinator: Robin Dowell
• Email: Robin.Dowell@moffitt.org
• Phone: 813-745-0393

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.