{"groups":[{"description":"Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.","id":"FG000","title":"Observation Arm"},{"description":"Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.","id":"FG001","title":"Herceptin 1-Year Arm"},{"description":"Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.","id":"FG002","title":"Herceptin 2-Year Arm"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"7"}],"type":"Adverse Event/Intercurrent Illness"},{"reasons":[{"groupId":"FG000","numSubjects":"22"},{"groupId":"FG001","numSubjects":"24"},{"groupId":"FG002","numSubjects":"17"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"542"},{"groupId":"FG001","numSubjects":"437"},{"groupId":"FG002","numSubjects":"445"}],"type":"Insufficient Therapeutic Response"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"6"}],"type":"Violation of Selection Criteria at Entry"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Other Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"142"},{"groupId":"FG001","numSubjects":"93"},{"groupId":"FG002","numSubjects":"84"}],"type":"Refused/Did Not Cooperate/Withdrew"},{"reasons":[{"groupId":"FG000","numSubjects":"57"},{"groupId":"FG001","numSubjects":"62"},{"groupId":"FG002","numSubjects":"61"}],"type":"Failure to Return"},{"reasons":[{"groupId":"FG000","numSubjects":"93"},{"groupId":"FG001","numSubjects":"84"},{"groupId":"FG002","numSubjects":"105"}],"type":"Other"}],"milestones":[{"achievements":[{"comment":"Included all participants with available signed Informed Consent Form.","groupId":"FG000","numSubjects":"1697"},{"comment":"Included all participants with available signed Informed Consent Form.","groupId":"FG001","numSubjects":"1702"},{"comment":"Included all participants with available signed Informed Consent Form.","groupId":"FG002","numSubjects":"1700"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"888"},{"comment":"This milestone is not applicable to participants who were already randomized to Herceptin.","groupId":"FG001","numSubjects":"0"},{"comment":"This milestone is not applicable to participants who were already randomized to Herceptin.","groupId":"FG002","numSubjects":"0"}],"type":"Crossover to Adjuvant Herceptin"},{"achievements":[{"groupId":"FG000","numSubjects":"834"},{"groupId":"FG001","numSubjects":"994"},{"groupId":"FG002","numSubjects":"974"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"863"},{"groupId":"FG001","numSubjects":"708"},{"groupId":"FG002","numSubjects":"726"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"After the release of initial study results, participants in the Observation Arm without disease recurrence were given the opportunity to cross over to receive 1 or 2 years of adjuvant Herceptin. Efficacy analyses were still performed according to original randomization."}