Clinical Trial 21448

• Overview

  Study Title:

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

  Summary:

  The purpose of the study is to determine the incidence of asymptomatic brain metastasis in stage IV breast cancer by subtype (triple negative (TN), HER2+, and hormone receptor (HR)+).

  Objective:

  Primary: To determine the incidence of asymptomatic brain metastasis in metastatic breast cancer by subtype. Secondary Objectives: To determine the incidence of asymptomatic leptomeningeal disease in metastatic breast cancer by subtype. To determine the number of brain metastases at initial diagnosis in metastatic breast cancer by subtype. To determine the size of the largest brain metastasis at initial diagnosis in metastatic breast cancer by subtype. To determine the number of patients requiring whole brain radiation therapy vs stereotactic radiation following brain metastasis diagnosis in metastatic breast cancer by subtype. To determine overall survival following brain metastasis diagnosis in metastatic breast cancer by subtype. To determine brain metastasis specific survival following brain metastasis diagnosis in metastatic breast cancer by subtype.

• Inclusion 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
  • 18 years of age or older
  • 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
  • Other criteria may apply

• Exclusion Criteria

  Exclusion Criteria
  • Prior diagnosis or treatment of brain metastases or leptomeningeal disease
  • Neurologic symptoms warranting standard screening brain MRI in the judgement of the treating physician at time of enrollment
  • Indications warranting screening brain MRI for other neurologic conditions at time of study entry
  • Patients with prior history of nonbreast cancer malignancies should have NED ≥ 2 years
  • Contraindication towards MRI imaging with gadolinium contrast
  • Chronic kidney disease stage IV or V or end stage renal disease (CrCl > Other exclusions may apply

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