{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"47"},{"groupId":"OG001","value":"21"},{"groupId":"OG002","value":"175"},{"groupId":"OG003","value":"179"}]}],"title":"Disease control rate"},{"categories":[{"measurements":[{"groupId":"OG000","value":"41"},{"groupId":"OG001","value":"20"},{"groupId":"OG002","value":"127"},{"groupId":"OG003","value":"130"}]}],"title":"Clinical benefit rate"}],"denoms":[{"counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"21"},{"groupId":"OG002","value":"180"},{"groupId":"OG003","value":"184"}],"units":"Participants"}],"description":"Number of participants with controlled disease and who received clinical benefit from treatment as assessed by independent central review. DCR was defined as the proportion of participants who achieved a best overall response of complete response, partial response, or stable disease. CBR was defined as the proportion of participants who achieved a best overall response of complete response or partial response or more than 6 months of stable disease.","groups":[{"description":"T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.","id":"OG000","title":"Part 1: DS-8201a Medium Dose"},{"description":"T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.","id":"OG001","title":"Part 1: DS-8201a High Dose"},{"description":"All T-DM1 resistant/refractory (R/R) participants who were treated at the recommended (5.4 mg/kg) dose in Part 1 or Part 2a.","id":"OG002","title":"Part 1 + Part 2a: DS-8201a Low Dose"},{"description":"All participants who were previously treated with T-DM1 and were randomized to receive DS8201a low dose (5.4 mg/kg) in Part 1 or Part 2a or Part 2b.","id":"OG003","title":"Part 1 + Part 2a + Part 2b: DS-8201a Low Dose"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Disease control rate (DCR) and clinical benefit rate (CBR) were assessed in the Enrolled Analysis Set at data cut-off date of 21 March 2019.","reportingStatus":"POSTED","timeFrame":"at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)","title":"Disease Control Rate and Clinical Benefit Rate as Confirmed by Independent Central Review Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)","type":"SECONDARY","unitOfMeasure":"Participants"}