Study of Screening Brain MRIs in Stage IV Breast Cancer

Study Purpose

The study is a single arm, nonrandomized phase II prospective study, with the goal of investigating the role of screening brain MRIs in neurologically asymptomatic patients with metastatic breast cancer.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05115474
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	H. Lee Moffitt Cancer Center and Research Institute
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Kamran A Ahmed, MD
Principal Investigator Affiliation	Moffitt Cancer Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Triple Negative Breast Cancer, HER2-positive Breast Cancer, Hormone Receptor-positive Breast Cancer
Study Website:	View Trial Website

Arms & Interventions

Arms

: Participants with TNBC (triple negative breast cancer)

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.

: Participants with Human Epidermal Growth Factor Receptor 2 (HER2) + Breast Cancer

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.

: Participants with Hormone Receptor (HR) +Breast Cancer

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.

Interventions

Diagnostic Test: - Magnetic Resonance Imaging

Participants will undergo MRI imaging with and without contrast.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Morton Plant Mease- Baycare, Clearwater, Florida

Status

Recruiting

Address

Morton Plant Mease- Baycare

Clearwater, Florida, 33756

Site Contact

Roberto Diaz, MD

[email protected]

813-745-0393

Moffitt Cancer Center, Tampa, Florida

Status

Recruiting

Address

Moffitt Cancer Center

Tampa, Florida, 33612

Site Contact

Robin Dowell

[email protected]

813-745-0393

Clinical Trial Finder