Trials Today

Study of Screening Brain MRIs in Stage IV Breast Cancer

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.

Conditions

Triple Negative Breast Cancer
HER2-positive Breast Cancer
Hormone Receptor-positive Breast Cancer

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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

Study Design

Phase
Study Type: Observational
Observational Model: Case-Only
Time Perspective: Prospective

Arm Groups

Arm	Description	Assigned Intervention
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.	Diagnostic Test: Magnetic Resonance Imaging Participants will undergo MRI imaging with and without contrast. Other names: MRI
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.	Diagnostic Test: Magnetic Resonance Imaging Participants will undergo MRI imaging with and without contrast. Other names: MRI
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.	Diagnostic Test: Magnetic Resonance Imaging Participants will undergo MRI imaging with and without contrast. Other names: MRI

Recruiting Locations

Morton Plant Mease- Baycare
Clearwater, Florida 33756

Contact:
Ronica H. Nanda, MD
Ronica.Nanda@baycare.org

More Details

NCT ID: NCT05115474
Status: Recruiting
Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Study Contact

Robin Dowell
813-745-0393
Robin.Dowell@moffitt.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.