{"groups":[{"description":"Doxorubicin 60 mg/m² intravenous (IV) bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.","id":"FG000","title":"Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)"},{"description":"Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.","id":"FG001","title":"AC Followed by Docetaxel + Herceptin (AC→TH)"},{"description":"Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.","id":"FG002","title":"Docetaxel + Carboplatin + Herceptin (TCH)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"18"},{"groupId":"FG002","numSubjects":"11"}],"type":"Breast cancer relapse"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"1"}],"type":"Second primary malignancy"},{"reasons":[{"groupId":"FG000","numSubjects":"41"},{"groupId":"FG001","numSubjects":"64"},{"groupId":"FG002","numSubjects":"26"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"3"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"61"},{"groupId":"FG002","numSubjects":"32"}],"type":"Cardiac toxicity"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"22"},{"groupId":"FG002","numSubjects":"6"}],"type":"Herceptin toxicity"},{"reasons":[{"groupId":"FG000","numSubjects":"46"},{"groupId":"FG001","numSubjects":"30"},{"groupId":"FG002","numSubjects":"18"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"38"},{"groupId":"FG002","numSubjects":"19"}],"type":"Other than specified above"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"27"},{"groupId":"FG002","numSubjects":"13"}],"type":"Missing"},{"reasons":[{"groupId":"FG000","numSubjects":"28"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"18"}],"type":"Randomized but not treated"}],"milestones":[{"achievements":[{"comment":"Randomized","groupId":"FG000","numSubjects":"1073"},{"comment":"Randomized","groupId":"FG001","numSubjects":"1074"},{"comment":"Randomized","groupId":"FG002","numSubjects":"1075"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"1045"},{"groupId":"FG001","numSubjects":"1072"},{"groupId":"FG002","numSubjects":"1057"}],"type":"Treated"},{"achievements":[{"comment":"1018 participants received AC-T (1012 from AC-T arm, 6 from AC-TH arm).","groupId":"FG000","numSubjects":"1018"},{"comment":"1100 participants received AC-TH (1066 from AC-TH arm, 33 from AC-T arm and 1 from TCH arm).","groupId":"FG001","numSubjects":"1100"},{"comment":"1056 participants received TCH.","groupId":"FG002","numSubjects":"1056"}],"type":"Safety Population"},{"achievements":[{"groupId":"FG000","numSubjects":"952"},{"groupId":"FG001","numSubjects":"804"},{"groupId":"FG002","numSubjects":"926"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"121"},{"groupId":"FG001","numSubjects":"270"},{"groupId":"FG002","numSubjects":"149"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Participants were randomized in 1:1:1 ratio to receive adjuvant therapy with either AC→ T, AC→ TH or TCH. During the course of the study, some participants received treatment different from the arm in which they were randomized. The safety analyses was conducted as per the treatment received.","recruitmentDetails":"The study was conducted at 433 centers in 43 countries. A total of 3222 participants randomized between 05 April 2001 and 30 March 2004. Participants stratified according to institution, nodal status(negative, positive 1-3 nodes, positive 4 or more nodes) and hormonal receptor status (estrogen and/or progesterone receptor positive versus negative)."}