Study of Screening Brain MRIs in Stage IV Breast Cancer

Launched by H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE · Nov 9, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the use of brain MRI scans to check for any potential issues in patients with advanced breast cancer who do not have any neurological symptoms. Specifically, it looks at patients with different types of breast cancer, including triple-negative, HER2-positive, and hormone receptor-positive breast cancer. The goal is to see if regular brain scans can help find problems early in patients who are currently feeling well.

To participate in this study, patients must be at least 18 years old and have been diagnosed with stage IV breast cancer that has progressed after initial treatment. They should not have a history of brain metastases (cancer spread to the brain) and must be able to understand and agree to the study procedures. Participants can expect to have their brain scanned and monitored throughout the study, and they should be available to follow the study's requirements for its duration. This trial is currently recruiting participants, and those who join will contribute to important research that could improve care for future breast cancer patients.

Gender

ALL

Eligibility 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