{"groups":[{"description":"Participants received placebo to veliparib orally twice a day in combination with carboplatin given at an area under the curve (AUC) of 6 milligrams per milliliter per minute (mg/mL/min) every 3 weeks, and paclitaxel 175 mg per square meter (mg/m²) of body-surface area (BSA), administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles.\n\nParticipants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.","id":"FG000","title":"Placebo + Carboplatin + Paclitaxel -> Placebo"},{"description":"Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles.\n\nParticipants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.","id":"FG001","title":"Veliparib + Carboplatin + Paclitaxel -> Placebo"},{"description":"Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles.\n\nParticipants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy.","id":"FG002","title":"Veliparib + Carboplatin + Paclitaxel -> Veliparib"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"224"},{"groupId":"FG001","numSubjects":"227"},{"groupId":"FG002","numSubjects":"199"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"21"},{"groupId":"FG001","numSubjects":"22"},{"groupId":"FG002","numSubjects":"31"}],"type":"Withdrew consent"},{"reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"15"},{"groupId":"FG002","numSubjects":"13"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"117"},{"groupId":"FG001","numSubjects":"110"},{"groupId":"FG002","numSubjects":"122"}],"type":"Sponsor discontinued study"},{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"14"}],"type":"Other, not specified"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"3"}],"type":"Missing due to site non-compliance"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"375"},{"groupId":"FG001","numSubjects":"383"},{"groupId":"FG002","numSubjects":"382"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"375"},{"groupId":"FG001","numSubjects":"383"},{"groupId":"FG002","numSubjects":"382"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Participants were randomized in a 1:1:1 ratio to one of three treatment groups. Randomization was stratified according to the timing of surgery and residual disease after primary surgery or interval surgery, the paclitaxel schedule, stage of disease, geographic region, and germline breast cancer susceptibility gene (BRCA) mutation status.","recruitmentDetails":"This trial was conducted at 188 sites in 10 countries (Australia, Brazil, Denmark, Israel, Japan, Poland, Republic of Korea, Spain, United Kingdom, and United States)."}