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. |
|
| 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. |
|
Recruiting Locations
Morton Plant Mease- Baycare
Clearwater, Florida 33756
Clearwater, Florida 33756
More Details
- NCT ID
- NCT05115474
- Status
- Recruiting
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute