{"groups":[{"description":"Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via single-use injection device (SID), and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by healthcare professional (HCP). Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 milligrams (mg) for all cycles where SC Herceptin was given, and the IV dose was 6 milligrams per kilogram (mg/kg) for all cycles where IV Herceptin was given.","id":"FG000","title":"Cohort 1: SC (SID) Then IV Herceptin"},{"description":"Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.","id":"FG001","title":"Cohort 1: IV Then SC (SID) Herceptin"},{"description":"Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via handheld syringe using the vial formulation, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.","id":"FG002","title":"Cohort 2: SC (Vial) Then IV Herceptin"},{"description":"Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via handheld syringe using the vial formulation. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.","id":"FG003","title":"Cohort 2: IV Then SC (Vial) Herceptin"}],"periods":[{"milestones":[{"achievements":[{"comment":"A total of 124 participants were randomized, but 2 did not receive any treatment.","groupId":"FG000","numSubjects":"122"},{"comment":"A total of 124 participants were randomized, but 2 did not receive any treatment.","groupId":"FG001","numSubjects":"122"},{"comment":"A total of 121 participants were randomized who all received study treatment.","groupId":"FG002","numSubjects":"121"},{"comment":"A total of 119 participants were randomized, but 1 did not receive any treatment.","groupId":"FG003","numSubjects":"118"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"119"},{"groupId":"FG001","numSubjects":"120"},{"groupId":"FG002","numSubjects":"119"},{"groupId":"FG003","numSubjects":"116"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"2"}],"type":"NOT COMPLETED"}],"title":"Crossover Treatment 1 (Cycles 1 to 4)"},{"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"119"},{"groupId":"FG001","numSubjects":"120"},{"groupId":"FG002","numSubjects":"119"},{"groupId":"FG003","numSubjects":"116"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"113"},{"groupId":"FG001","numSubjects":"116"},{"groupId":"FG002","numSubjects":"107"},{"groupId":"FG003","numSubjects":"105"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"12"},{"groupId":"FG003","numSubjects":"11"}],"type":"NOT COMPLETED"}],"title":"Crossover Treatment 2 (Cycles 5 to 8)"},{"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"113"},{"groupId":"FG001","numSubjects":"116"},{"groupId":"FG002","numSubjects":"107"},{"groupId":"FG003","numSubjects":"105"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"109"},{"groupId":"FG001","numSubjects":"109"},{"groupId":"FG002","numSubjects":"105"},{"groupId":"FG003","numSubjects":"102"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"3"}],"type":"NOT COMPLETED"}],"title":"Continuation Treatment (Cycles 9 to 18)"},{"milestones":[{"achievements":[{"comment":"All 124 randomized participants entered follow-up regardless of whether they received treatment.","groupId":"FG000","numSubjects":"124"},{"comment":"All 124 randomized participants entered follow-up regardless of whether they received treatment.","groupId":"FG001","numSubjects":"124"},{"comment":"All 121 randomized participants entered follow-up regardless of whether they received treatment.","groupId":"FG002","numSubjects":"121"},{"comment":"All 119 randomized participants entered follow-up regardless of whether they received treatment.","groupId":"FG003","numSubjects":"119"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"99"},{"groupId":"FG001","numSubjects":"106"},{"groupId":"FG002","numSubjects":"104"},{"groupId":"FG003","numSubjects":"100"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"25"},{"groupId":"FG001","numSubjects":"18"},{"groupId":"FG002","numSubjects":"17"},{"groupId":"FG003","numSubjects":"19"}],"type":"NOT COMPLETED"}],"title":"Safety Follow-Up Period"}],"preAssignmentDetails":"A total of 248 participants were randomized into the study in Cohort 1 (of whom 244 were treated) and 240 participants were randomized into the study in Cohort 2 (of whom 239 were treated). Those participants who did not receive any treatment were not included in the treatment periods of the Participant Flow."}