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NCT05115474 Clinical Trial

Study of Screening Brain MRIs in Stage IV Breast Cancer

Triple Negative Breast Cancer Clinical Trial

Official title:
Phase II Study of Screening Brain MRIs in Stage IV Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05115474
Other study ID # MCC-21448
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 21, 2021
Est. completion date August 31, 2024

Study information
Verified date January 2024
Source H. Lee Moffitt Cancer Center and Research Institute
Contact Robin Dowell
Phone 813-745-0393
Email Robin.Dowell@moffitt.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date August 31, 2024
Est. primary completion date August 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Magnetic Resonance Imaging
Participants will undergo MRI imaging with and without contrast.

Locations
Country Name City State
United States Morton Plant Mease- Baycare Clearwater Florida
United States Moffitt Cancer Center Tampa Florida

Sponsors (2)
Lead Sponsor Collaborator
H. Lee Moffitt Cancer Center and Research Institute Florida Breast Cancer Foundation

Country where clinical trial is conducted

United States, 

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