MRI Screening for Breast Cancer

Recruiting at 1 trial location

Overseen By Robin Dowell

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

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

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

170 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the use of brain MRIs (scans that provide detailed images of the brain) for individuals with stage IV breast cancer who lack symptoms affecting their nervous system. It targets specific breast cancer types: triple-negative, HER2 positive, and hormone receptor positive. Participants will undergo a brain MRI at the start and another if their cancer progresses or after six months. This study includes those diagnosed with stage IV breast cancer who have not yet experienced brain issues. As a Phase 2 trial, it measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important research.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this MRI screening is safe for breast cancer patients?

Research has shown that Magnetic Resonance Imaging (MRI) is generally safe for patients. MRI is a common method for capturing detailed images of the body's internal organs and tissues. Studies have found that MRI can effectively detect issues, such as cancer that has spread to the brain, without exposing patients to harmful radiation.

Most people tolerate MRI well and experience no side effects. However, some may feel discomfort from lying still or being inside the machine for an extended period. Patients with metal implants, such as pacemakers, should inform their doctor, as MRI uses strong magnets.

Overall, MRI is considered safe for most people and is widely used in medical practice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using screening brain MRIs in stage IV breast cancer patients because this approach could lead to earlier detection of brain metastases. Unlike traditional methods that may wait for symptoms to appear, MRIs can potentially catch issues before they cause noticeable problems, allowing for more timely interventions. This proactive monitoring could help improve outcomes by addressing metastases sooner, which is crucial in managing advanced cancer stages.

What evidence suggests that MRI screening is effective for detecting brain metastases in breast cancer patients?

Studies have shown that MRI surpasses mammography in detecting tumors, particularly in women with a genetic risk of breast cancer. This capability allows MRI to detect cancer earlier, potentially improving survival rates. Research also suggests that MRI can lower the risk of dying from breast cancer in women with specific genetic traits. However, there isn't enough evidence yet to recommend MRI as a regular screening tool for everyone. In this trial, participants with various types of breast cancer, including TNBC, HER2+, and HR+ breast cancer, will undergo MRI screenings to assess its effectiveness in detecting and monitoring cancer progression. MRI has demonstrated advantages over other imaging methods in identifying and treating breast cancer. ^{6 7 8 9 10}

Who Is on the Research Team?

Kamran A Ahmed, MD

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Baseline

1 visit (in-person)

Initial MRI Screening

Participants undergo a screening brain MRI to assess for asymptomatic brain metastases

Baseline

1 visit (in-person)

Follow-up MRI

Participants undergo a second brain MRI at first systemic progression or at 6 months, whichever occurs sooner

Up to 6 months

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the follow-up MRI

Up to 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Magnetic Resonance Imaging

How Is the Trial Designed?

Group I: Participants with TNBC (triple negative breast cancer) Experimental Treatment 1 Intervention

Participants will undergo a screening brain MRI. Patients will undergo a second brain MRI at first systemic progression or at 6 months whichever event occurs sooner.

Group II: Participants with Human Epidermal Growth Factor Receptor 2 (HER2) + Breast Cancer Experimental Treatment 1 Intervention

Participants will undergo a screening brain MRI. Patients will undergo a second brain MRI at first systemic progression or at 6 months whichever event occurs sooner.

Group III: Participants with Hormone Receptor (HR) +Breast Cancer Experimental Treatment 1 Intervention

Participants will undergo a screening brain MRI. Patients will undergo a second brain MRI at first systemic progression or at 6 months whichever event occurs sooner.

Magnetic Resonance Imaging is already approved in United States for the following indications:

Approved in United States as Lumakras (sotorasib) for:

• Non-small cell lung cancer with KRAS G12C mutation

Approved in United States as Vectibix (panitumumab) for:

• Advanced colorectal cancer that is wild-type RAS

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

Florida Breast Cancer Foundation

Collaborator

Trials

3

Recruited

190+

Florida Breast Cancer Foundation

Collaborator

Trials

4

Recruited

310+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6999769/

Survival Outcomes of Screening with Breast MRI in Women ... Combined screening with MRI and mammography in women at elevated risk of breast cancer improves cancer detection and overall survival.

2. uspreventiveservicestaskforce.org uspreventiveservicestaskforce.org/uspstf/recommendation/breast-cancer-screening

Recommendation: Breast Cancer: Screening There is insufficient evidence to recommend for or against supplemental screening using breast ultrasonography or MRI in women who have dense ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa031759

Efficacy of MRI and Mammography for Breast-Cancer ... MRI appears to be more sensitive than mammography in detecting tumors in women with an inherited susceptibility to breast cancer.

4. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2815702

MRI Surveillance and Breast Cancer Mortality in Women ... Results of this study suggest that among women with a BRCA1 sequence variation, MRI surveillance is associated with reduced breast cancer mortality risk.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2352047724000406

The association of magnetic resonance imaging features ... Regarding the diagnosis and treatment of breast cancer, magnetic resonance imaging (MRI) has demonstrated numerous advantages over other imaging methods [11].

6. pubs.rsna.org pubs.rsna.org/doi/10.1148/radiol.250439

Preoperative Breast MRI and Survival Outcomes in Women ... Undergoing preoperative MRI was associated with reduced risk of ipsilateral in-breast recurrence in patients 50 years or younger with breast ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11324846/

MRI-based machine learning radiomics for prediction of ... This study aimed to explore the effectiveness of a multisequence magnetic resonance imaging (MRI)-based machine learning radiomics model in classifying the ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04030507

NCT04030507 | Screening Magnetic Resonance Imaging ... This research study is studying the usefulness of magnetic resonance imaging (MRI) to screen for brain metastases (spread of the breast cancer to the brain).

9. sciencedirect.com sciencedirect.com/science/article/pii/S0720048X24004972

MRI-only breast cancers are less aggressive than ... Our data provide evidence that MRI-only lesions are biologically less aggressive and of lower stage, offering the potential of earlier treatment chance.

10. academic.oup.com academic.oup.com/jnci/article/93/14/1095/2906216?login=true

Magnetic Resonance Imaging and Mammography in Women ... Results: In the cohort of 179 women, we detected 13 breast cancers. Seven cancers were not revealed by mammography, but all were detected by MRI. For the entire ...