Monitoring Early Response to Targeted Therapy in Stage IV Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Breast Cancer Patients with Advanced Positron Emission Tomography (PET)/magnetic Resonance Imaging (MRI)
The purpose of the study is to see if a new group of imaging tests can help identify response to stage IV HER2+ breast cancer before treatment.
• Patients must be ≥ 18 years old and ≤ 75 years old
• Patients with HER2+ metastatic breast cancer
• HER2-positive breast cancer prospectively determined on the primary tumor by a local pathology laboratory and defined as immunohistochemistry (IHC) score of 3+ and/or positive by in situ hybridization (ISH) (defined by ISH ratio of ≥ 2.0 for the number of HER2 gene copies to the number of chromosome 17 copies). Only one positive result is required for eligibility
• Estrogen/progesterone receptor positive OR negative disease allowed
• Patients must have measurable disease in one metastatic lesion per RECIST v 1.1
• Stage IV HER2+ breast cancer patients eligible for a new therapeutic regimen that includes HER2-targeted treatment who are naïve to that regimen
• Estimated life expectancy of greater than six months