Study of Screening Brain MRIs in Stage IV Breast Cancer

Description

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.

Conditions

Triple Negative Breast Cancer, HER2-positive Breast Cancer, Hormone Receptor-positive Breast Cancer

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Study Overview

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Study Details

Study overview

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.

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

Study of Screening Brain MRIs in Stage IV Breast Cancer

Condition
Triple Negative Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Clearwater

Morton Plant Mease- Baycare, Clearwater, Florida, United States, 33756

Tampa

Moffitt Cancer Center, Tampa, Florida, United States, 33612

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

H. Lee Moffitt Cancer Center and Research Institute,

Kamran A Ahmed, MD, PRINCIPAL_INVESTIGATOR, Moffitt Cancer Center

Study Record Dates

2026-06