Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Breast Cancer
  • HER2 Positive Breast Cancer
  • Hormone Receptor Positive Malignant Neoplasm of Breast
  • Inflammatory Breast Cancer
  • Metastatic Breast Cancer
  • Triple -Negative Breast Cancer
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Screening

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

This research study is a Phase II clinical trial. Phase II clinical trials examine the safety and effectiveness of an investigational intervention, in this case magnetic resonance imaging (MRI) of the brain, to learn whether it is helpful in managing a specific disease. In this research study, the i...

This research study is a Phase II clinical trial. Phase II clinical trials examine the safety and effectiveness of an investigational intervention, in this case magnetic resonance imaging (MRI) of the brain, to learn whether it is helpful in managing a specific disease. In this research study, the investigators are utilizing screening MRIs of the brain to evaluate breast cancer patients for metastases to the brain. The investigators hope to understand whether screening MRIs of the brain can be implemented into the standard of care to earlier detect brain metastases in a population where screening MRIs of the brain are not currently recommended or systematically performed. This trial will contain 4 cohorts: 1. Those with triple negative breast cancer (TNBC) will undergo screening MRI of the brain as part of a single arm, non-comparative study 2+3. Those with hormone receptor positive/(human epidermal growth factor receptor 2 (HER2) negative (HR+/HER2-) and HER2 positive (HER2+) subtypes will be randomized to receipt of screening MRI of the brain or no screening MRI of the brain to definitively test the value of MRI screening. 4. Patients with inflammatory breast cancer being treated with curative intent will undergo screening MRI of the brain as part of a single arm, non-comparative study.

Tracking Information

NCT #
NCT04030507
Collaborators
Conquer Cancer Foundation
Investigators
Principal Investigator: Ayal Aizer, MD, MHS Brigham and Women's Hospital