Phase III Trial of Brain MRI Surveillance in Stage IV Breast Cancer
Recruiting
Phase 3Interventional Study
Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Screening
Participants needed
156 (estimated)
Sponsor
H. Lee Moffitt Cancer Center and Research Institute · Other
Who this trial is looking for
This trial is looking for women with stage IV breast cancer who do not have symptoms affecting their brain. Participants will get brain MRI scans every 6 months to see if this helps find brain issues earlier.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with breast cancer.
I am at stage IV of the disease.
I am 18 years old or older.
I expect to live at least 6 more months.
I can understand and sign consent forms.
I agree to follow all study procedures.
I have ER/PR/HER2 status documented.
You may not be able to join if
I have had brain metastases or leptomeningeal disease before.
I have a history of another serious cancer that needs treatment.
I have symptoms that require a standard brain MRI.
I have conditions like multiple sclerosis or stroke that need a brain MRI.
I cannot have an MRI with contrast.
I have severe kidney disease or am in end stage renal disease.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
This randomized, multi-institutional phase III trial evaluates whether routine surveillance brain MRI every 6 months improves detection and treatment characteristics of brain metastases in neurologically asymptomatic patients with stage IV breast cancer. Patients are stratified by receptor subtype, age, prior therapy, and study site, then randomized 1:1 to either scheduled surveillance MRIs or sta…
This randomized, multi-institutional phase III trial evaluates whether routine surveillance brain MRI every 6 months improves detection and treatment characteristics of brain metastases in neurologically asymptomatic patients with stage IV breast cancer. Patients are stratified by receptor subtype, age, prior therapy, and study site, then randomized 1:1 to either scheduled surveillance MRIs or standard-of-care symptom-triggered imaging. The study aims to determine whether earlier detection leads to differences in treatment modality, frequency of brain metastases, leptomeningeal disease incidence, quality of life, and survival outcomes.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
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 th…
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)
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.