{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"3"}],"units":"Participants"}],"description":"Patients were expected to start endocrine therapy within 2 weeks of the FES PET scan. Response assessment was evaluated at 3 and 6 months. For patients with at least one site of measurable disease \\[per response evaluation criteria in solid tumors (RECIST, version 1.1)\\], size-based response criteria were used to assess response.\n\nFor patients without disease evaluable by RECIST 1.1, largely patients with bone-dominant metastatic breast cancer, serial FDG PET scanning was used to determine response. A decline in the FDG PET SUV (standard uptake value) of 30% or more was considered as response and an increase of 20% or more was considered to be progressive disease (PD).\n\nThe initial (baseline) FES uptake was compared to clinical benefit (PD versus other outcome at 6 months).","groups":[{"description":"Patients undergo \\[\\^18F\\] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to \\[\\^18F\\] FES PET scan.\n\nPatients begin clinically indicated endocrine therapy.\n\nPatients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT.\n\nThis group represents patients who had positive FES uptake at all disease sites on the baseline diagnostic FES PET scan.\n\nlaboratory biomarker analysis: Correlative studies","id":"OG000","title":"Diagnostic FES: Average FES SUVmean >1.5, no Negative Sites"},{"description":"Patients undergo \\[\\^18F\\] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to \\[\\^18F\\] FES PET scan.\n\nPatients begin clinically indicated endocrine therapy.\n\nPatients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT.\n\nThis group represents patients who had some or all disease sites negative for FES uptake on the baseline diagnostic FES PET scan.","id":"OG001","title":"Diagnostic FES: Patients With FES Negative Sites of Disease"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"Up to 6 months","title":"Best Overall Response","type":"PRIMARY","unitOfMeasure":"patients with progressive disease"}