Surveillance Brain MRI for Breast Cancer

Not yet recruiting at 1 trial location

Overseen By Rheese McNab

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Disqualifiers: Brain metastases, Leptomeningeal disease, Neurologic symptoms, Chronic kidney disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether regular brain MRIs every six months can detect brain metastases earlier in patients with stage IV breast cancer who have not shown neurological symptoms. The researchers aim to determine if earlier detection affects treatment options, quality of life, or survival. Participants are randomly assigned to receive either regular MRIs (Surveillance Brain MRI) or MRIs only if symptoms appear. Candidates may qualify if they have stage IV breast cancer, no prior brain issues, and are open to regular MRIs. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in cancer care.

What prior data suggests that surveillance brain MRI is safe for breast cancer patients?

Research has shown that regular brain MRIs (magnetic resonance imaging) can detect brain problems early in individuals with stage IV breast cancer. In earlier studies, participants who underwent regular MRI scans had a lower risk of dying from breast cancer compared to those who did not. This suggests that early detection might improve health outcomes.

MRIs are generally safe for most people, as they do not use radiation. Some individuals might feel uncomfortable due to the noise or confined space during the scan, but these sensations are usually manageable. No major problems from the MRIs themselves have been reported in these studies. Overall, patients handle the process well.

For those considering participation in a trial involving regular brain MRIs, it is reassuring to know that the procedure is generally safe and might lead to better health outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Surveillance Brain MRI approach because it offers a proactive strategy for breast cancer patients by regularly monitoring brain health, even if no symptoms are present. Unlike the standard of care, which only involves brain imaging when neurological symptoms arise, this method involves scheduled MRIs every six months over two years. This could potentially catch metastases earlier, allowing for timely interventions that might improve outcomes or quality of life for patients.

What evidence suggests that this trial's treatments could be effective for detecting brain metastases in stage IV breast cancer?

Research has shown that regular brain MRI scans can significantly impact breast cancer outcomes. For example, one study found that MRI scans reduced breast cancer deaths by 80% in some high-risk groups. Another study discovered that regular brain MRI scans in patients with stage IV breast cancer identified a high risk of cancer spreading to the brain, emphasizing the importance of early detection. In this trial, participants in the Surveillance Brain MRI arm will receive a baseline brain MRI, followed by surveillance brain MRI every 6 months for 24 months. Studies suggest this approach might improve survival and quality of life by catching issues early. Meanwhile, participants in the Standard of Care Brain Imaging arm will receive a baseline brain MRI, followed by standard-of-care imaging only if neurologic symptoms develop. ^{1 2 3 4 5}

Who Is on the Research Team?

Kamran Ahmed, MD

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

This trial is for neurologically asymptomatic stage IV breast cancer patients. It's open to various ages and those who've had prior therapy, but specifics like receptor subtype and study site will determine their group. Participants must not have any conditions that would interfere with MRI procedures.

Inclusion Criteria

My breast cancer's hormone and HER2 status are documented.

Life expectancy ≥ 6 months

I was diagnosed with stage IV cancer outside the brain within the last 60 days or started treatment recently.

Exclusion Criteria

I have had brain metastases or leptomeningeal disease.

I have had cancer other than breast cancer, but it was low risk and not likely to spread.

Neurologic symptoms warranting standard screening brain MRI in the judgement of the treating physician at time of enrollment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline MRI

Participants receive a baseline brain MRI to establish initial conditions

1 week

1 visit (in-person)

Surveillance

Participants receive surveillance brain MRI every 6 months for 24 months

24 months

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the surveillance period

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Standard of Care Brain Imaging
• Surveillance Brain MRI

Trial Overview

The trial tests if routine brain MRIs every 6 months can better detect and treat brain metastases in these patients compared to standard care where imaging is done based on symptoms. The goal is to see if this leads to earlier detection and affects treatment choices, disease spread, quality of life, or survival.

How Is the Trial Designed?

Group I: Surveillance Brain MRI Experimental Treatment 1 Intervention

Participants receive a baseline brain MRI followed by surveillance brain MRI every 6 months for 24 months.

Group II: Standard of Care Brain Imaging Experimental Treatment 1 Intervention

Participants receive a baseline brain MRI followed by standard-of-care imaging only if neurologic symptoms develop.

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

Florida Department of Health

Collaborator

Trials

30

Recruited

13,000+

Florida Biomedical Research Program - Bankhead Coley

Collaborator

Trials

1

Recruited

350+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10905376/

MRI Surveillance and Breast Cancer Mortality in Women With ...

At 20 years, the risk of breast cancer mortality was 3.2% in the MRI surveillance group compared with 14.9% for women who did not undergo MRI ...

2.

ascopubs.org

ascopubs.org/doi/10.1200/JCO-25-00356

Brain Imaging Surveillance for Patients With Metastatic ...

These data confirm a substantially high risk of brain metastases across breast cancer ... brain MRI surveillance in stage IV breast cancer. Neuro ...

3.

breakthroughsforphysicians.nm.org

breakthroughsforphysicians.nm.org/oncology-clinical-article-mri-surveillance-reduces-breast-cancer-mortality

MRI Surveillance Cuts Breast Cancer Mortality by 80% in ...

A study reveals that MRI surveillance reduces breast cancer mortality by 80% in BRCA1 mutation carriers. Underscores the importance of early ...

4.

thebreastonline.com

thebreastonline.com/article/S0960-9776(25)00575-2/fulltext

Brain imaging screening in metastatic breast cancer

Notably, 91 % of patients would like to receive information regarding BM, while only 13 % of physicians routinely address the issue. Conclusions.

5.

mbcbrainmets.org

mbcbrainmets.org/wp-content/uploads/2025/03/Neuro-Onc-2025-Brain-MRI-Surveillance.pdf

Phase II trial of brain MRI surveillance in stage IV breast ...

On initial surveillance brain MRI, the frequency of brain metastases was 14%. Following the 6-month MRI, the cumulative rate of brain metastasis was 24%.