{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"53.8","upperLimit":"68.9","value":"61.5"},{"groupId":"OG001","lowerLimit":"37.2","upperLimit":"52.5","value":"44.8"},{"groupId":"OG002","lowerLimit":"44.4","upperLimit":"63.2","value":"53.9"},{"groupId":"OG003","lowerLimit":"39.7","upperLimit":"58.6","value":"49.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"169"},{"groupId":"OG001","value":"172"},{"groupId":"OG002","value":"115"},{"groupId":"OG003","value":"116"}],"units":"Participants"}],"description":"Clinical benefit rate was defined as the percentage of patients with a best overall response of CR or PR or stable disease (SD) or Non-CR/Non-PD lasting more than 24 weeks based on local investigator assessment according to RECIST 1.1.\n\nCR: Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target and non-target lesions must have a reduction in short axis to \\< 10 mm.\n\nPR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.\n\nSD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.","dispersionType":"95% Confidence Interval","groups":[{"description":"Subjects with advanced breast cancer with a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)","id":"OG000","title":"PIK3CA Mutant Cohort by Tumor Tissue: Alpelisib + Fulvestrant"},{"description":"Subjects with advanced breast cancer with a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)","id":"OG001","title":"PIK3CA Mutant Cohort by Tumor Tissue: Placebo + Fulvestrant"},{"description":"Subjects with advanced breast cancer without a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with alpelisib (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)","id":"OG002","title":"PIK3CA Non-mutant Cohort by Tumor Tissue: Alpelisib + Fulvestrant"},{"description":"Subjects with advanced breast cancer without a PIK3CA mutation (based on central testing of hotspot-mutations in tumor tissue) treated with placebo (300 mg; oral; once daily) in combination with fulvestrant (500 mg; intramuscular injection on Day 1 and Day 15 of Cycle 1, and then Day 1 of each subsequent 28-day cycle)","id":"OG003","title":"PIK3CA Non-mutant Cohort by Tumor Tissue: Placebo + Fulvestrant"}],"paramType":"NUMBER","populationDescription":"All subjects who were randomized to study treatment.","reportingStatus":"POSTED","timeFrame":"Up to 56.4 months","title":"Clinical Benefit Rate (CBR) Per Investigator Assessment","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}