Breast Cancer Clinical Trial

Study of Screening Brain MRIs in Stage IV Breast Cancer

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.

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

100

Study ID:

NCT05115474

Recruitment Status:

Recruiting

Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

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There are 2 Locations for this study

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Morton Plant Mease- Baycare
Clearwater Florida, 33756, United States More Info
Roberto Diaz, MD
Contact
[email protected]
Ronica Nanda, MD
Contact
[email protected]
Roberto Diaz, MD
Principal Investigator
Moffitt Cancer Center
Tampa Florida, 33612, United States More Info
Robin Dowell
Contact
813-745-0393
[email protected]
Avan Armaghani, MD
Sub-Investigator
John Arrington, MD
Sub-Investigator
Ricardo Costa, MD, MSc
Sub-Investigator
Roberto Diaz, MD, PhD
Sub-Investigator
Heather Han, MD
Sub-Investigator
Hung Khong, MD
Sub-Investigator
Kimberley Lee, MD, MHS
Sub-Investigator
Loretta Loftus, MD, MBA
Sub-Investigator
Marilin Rosa, MD
Sub-Investigator
Hatem Soliman, MD
Sub-Investigator
Aixa Soyano Muller, MD
Sub-Investigator
Iman Washington, MD
Sub-Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

100

Study ID:

NCT05115474

Recruitment Status:

Recruiting

Sponsor:


H. Lee Moffitt Cancer Center and Research Institute

How clear is this clinincal trial information?

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