{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.6"},{"groupId":"OG001","value":"2.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"190"},{"groupId":"OG001","value":"191"}],"units":"Participants"}],"title":"At Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4.6"},{"groupId":"OG001","value":"3.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"195"},{"groupId":"OG001","value":"197"}],"units":"Participants"}],"title":"Anytime Post-Baseline"}],"denoms":[{"counts":[{"groupId":"OG000","value":"199"},{"groupId":"OG001","value":"201"}],"units":"Participants"}],"description":"ATAs to pertuzumab in serum samples were detected using a validated bridging enzyme-linked immunosorbent assay (ELISA) method. This analysis only included participants with an ATA assay result from a baseline sample and/or at least one post-baseline sample.","groups":[{"description":"Participants received neoadjuvant treatment with dose-dense doxorubicin and cyclophosphamide (ddAC), with administration of doxorubicin 60 milligrams per square meter (mg/m\\^2) intravenously (IV) once every 2 weeks (q2w) and cyclophosphamide 600mg/m\\^2 IV q2w for 4 cycles, followed by paclitaxel 80mg/m\\^2 IV once weekly (qw) for 12 weeks. Pertuzumab (840 milligrams \\[mg\\] IV loading dose then 420mg IV q3w) and trastuzumab (8 milligrams per kilogram \\[mg/kg\\] IV loading dose then 4mg/kg IV q3w) were administered along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years.","id":"OG000","title":"Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab"},{"description":"Participants received neoadjuvant treatment with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), with administration of 5-fluorouracil 500mg/m\\^2 intravenously (IV) q3w, epirubicin 100mg/m\\^2 IV q3w, and cyclophosphamide 600mg/m\\^2 IV q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m\\^2 in Cycle 5, then 100mg/m\\^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab (840 mg IV loading dose then 420mg IV q3w) and trastuzumab (8 mg/kg IV loading dose then 4mg/kg IV q3w) were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years.","id":"OG001","title":"Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab"}],"paramType":"NUMBER","populationDescription":"This analysis only included participants with an ATA assay result from a baseline sample and/or at least one post-baseline sample.","reportingStatus":"POSTED","timeFrame":"Screening (baseline) then prior to pertuzumab infusion (Hour 0) in Cycles 5, 14, 18 thereafter anytime between Cycle 8 Day 21 and surgery, up to treatment completion visit (cycle length=2-3 weeks; up to approximately 1 year, 3 months)","title":"Percentage of Participants Positive for Anti-Therapeutic Antibodies (ATAs) to Pertuzumab at Baseline and Anytime Post-Baseline","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}