Brain MRI checks every 6 months for people 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

In this randomized, multi‑center study, patients are assigned 1:1 to scheduled brain MRI surveillance every six months or to imaging only when symptoms appear. Participants are stratified by receptor subtype, age, prior therapy, and site before randomization. The goal is to see if earlier detection changes treatment choices, brain metastasis frequency, occurrence of leptomeningeal disease, quality of life, and survival. Brain imaging uses standard surveillance MRI versus standard-of-care imaging triggered by symptoms. The study is led by H. Lee Moffitt Cancer Center with regional collaborators and sites in Florida.

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 disease enrolled within 60 days of diagnosis or starting first line therapy. HR+/HER2- patients may be enrolled within 60 days of starting 2nd line therapy as well.
* HR+ will be defined as ER and/or PR \> 10%. To be classified as HER2+ disease, overexpression of HER2 by either IHC or in-situ hybridization is necessary as defined by the ASCO / CAP Guidelines41. Triple negative will be classified as ER and PR \<10% and HER2-.
* Age ≥ 18
* Life expectancy ≥ 6 months
* Eastern Cooperative Oncology Group performance status ≤ 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
* History of other non-breast malignancy requiring treatment with the exception of those with a negligible risk of metastasis or death (e.g., 5-year OS of \> 90%), such as but not limited to, non-melanoma skin cancers, stage I endometrioid uterine cancer, and others at the discretion of the PI
* 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 (including multiple sclerosis, stroke, traumatic brain injuries, epilepsy, hydrocephalus and pituitary gland disorders)
* Contraindication towards MRI with contrast
* Chronic kidney disease stage IV or V or end stage renal disease (CrCl \<30 ml/min)

Where it's running

• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting
• Baptist Health South Florida
  Miami, Florida, United States Not yet recruiting

Study contacts

• Principal investigator: Kamran Ahmed, MD — Moffitt Cancer Center
• Study coordinator: Rheese McNab
• Email: Rheese.McNab@moffitt.org
• Phone: 813-745-1780

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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.