Subjects with metastatic breast cancer are planned to be enrolled to undergo Ga-68-DOTATATE PET/CT imaging at one time point. SSTR uptake in metastatic lesions will be evaluated by independent central review (ICR). FED PET and bone scans will also be performed within +/- 3 weeks of DOTA imaging.~The primary objective of this study is to evaluate uptake of Ga-68-DOTATE in metastatic ER+ breast cancer lesions. Additionally, the exploratory objective of this Phase 2 study is to evaluate the relationship between biomarkers and concomitant endocrine therapy with Ga-68-DOTATATE uptake.
This will be a Phase 2 clinical trial to assess somatostatin receptor (SSTR) expression in Stage IV estrogen receptor positive (ER+) breast cancer using Ga-68-DOTATATE PET/CT.