Study of Screening Brain MRIs in Stage IV Breast Cancer

Recruiting

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

• Registration Number: NCT05115474
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-01
• Study First Submitted QC: 2021-11-09
• Study First Posted: 2021-11-10
• Study Start: 2021-12-21
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-14
• Last Update Posted: 2025-08-15
• Primary Completion: 2025-10-07
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 170

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of Brain Metastasis	up to 6 months	Rate of brain metastasis by breast cancer subtype at 6 months or first systemic progression using MRI images.

Secondary Outcome Measures

Name	Time	Method
Number of Brain Metastases	Baseline	Number of Brain Metastases at Diagnosis by Breast Cancer Subtype, using MRI images.
Brain Metastasis Specific Survival	Up to 6 months	Brain metastasis specific survival following brain metastasis by breast cancer subtype
Rate of Asymptomatic Leptomeningeal Disease	Baseline and at up to 6 months	Rate of asymptomatic leptomeningeal disease by breast cancer subtype at baseline and at 6 months or first systemic progression, using MRI images.
Overall Survival	Up to 6 months	Overall Survival (OS) will be measured from the initial on study date to the recorded date of death.
Number of Participants Requiring Whole Brain Radiation Therapy vs Stereotactic Radiation	Up to 6 months	Number of Participants Requiring Whole Brain Radiation Therapy vs Stereotactic Radiation by breast cancer type.

Trial Locations

Locations (2)

Morton Plant Mease- Baycare; 🇺🇸 Clearwater, Florida, United States

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States