Study of Screening Brain MRIs in Stage IV Breast Cancer

H. Lee Moffitt Cancer Center and Research Institute

Status: Enrolling

Conditions: Hormone Receptor-positive Breast Cancer; HER2-positive Breast Cancer; Triple Negative Breast Cancer

Treatments: Diagnostic Test: Magnetic Resonance Imaging

Study type: Observational

Funder types: Other

Identifiers

NCT05115474

MCC-21448

Details and patient eligibility

About

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.

Enrollment: 170 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

170 participants in 3 patient groups

Participants with TNBC (triple negative breast cancer)

Description:

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.

Treatment:

Diagnostic Test: Magnetic Resonance Imaging

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

Description:

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.

Treatment:

Diagnostic Test: Magnetic Resonance Imaging

Participants with Hormone Receptor (HR) +Breast Cancer

Description:

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.

Treatment:

Diagnostic Test: Magnetic Resonance Imaging