{"groups":[{"description":"Participants received trastuzumab, 6 milligram per kilograms (mg/kg), intravenously (IV), every 3 weeks (Q3W), as a maintenance dose for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.","id":"FG000","title":"Trastuzumab"},{"description":"Participants received trastuzumab emtansine, 3.6 mg/kg, IV, Q3W for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.","id":"FG001","title":"Trastuzumab Emtansine"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"126"},{"groupId":"FG001","numSubjects":"94"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"51"},{"groupId":"FG001","numSubjects":"50"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"7"}],"type":"Other"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"7"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"115"},{"groupId":"FG001","numSubjects":"90"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"441"},{"groupId":"FG001","numSubjects":"495"}],"type":"Follow-up Terminated by Sponsor"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"743"},{"groupId":"FG001","numSubjects":"743"}],"type":"STARTED"},{"achievements":[{"comment":"1 participant in trastuzumab emtansine arm received 9 cycles of trastuzumab \\& included in trastuzumab safety analysis.","groupId":"FG000","numSubjects":"720"},{"comment":"1 participant randomized to trastuzumab arm was untreated, later re-randomized to trastuzumab emtansine arm \\& received treatment. Another participant in the trastuzumab arm received 13 cycles of trastuzumab \\& 1 of trastuzumab emtansine. Both these participants were included in the trastuzumab emtansine safety analysis.","groupId":"FG001","numSubjects":"740"}],"comment":"SE population included all randomized participants who received any amount of study treatment.","type":"Safety-evaluable (SE) Population"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"743"},{"groupId":"FG001","numSubjects":"743"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Participants received either trastuzumab or trastuzumab emtansine (T-DM1). 1 participant randomized to trastuzumab arm was untreated, later re-randomized to T-DM1 arm \\& received treatment. Another participant in the trastuzumab arm received 13 cycles of trastuzumab \\& 1 of T-DM1. Both these participants were included in the trastuzumab ITT population and T-DM1 safety analysis. 1 participant in T-DM1 arm received 9 cycles of trastuzumab \\& included in trastuzumab safety analysis.","recruitmentDetails":"A total of 1486 participants with human epidermal growth factor receptor 2 (HER2)-positive primary breast cancer who had residual invasive disease in either the breast or axillary lymph nodes took part in the study at 268 investigative sites across 28 countries from April 03, 2013 to May 23, 2024."}