{"groups":[{"description":"Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received T-DXd as a sterile intravenous (IV) solution at a dose of 5.4 mg/kg every 3 weeks (Q3W).","id":"FG000","title":"Trastuzumab Deruxtecan (T-DXd)"},{"description":"Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received investigator's choice treatment, Trastuzumab/Capecitabine.","id":"FG001","title":"Trastuzumab+Capecitabine"},{"description":"Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received investigator's choice treatment, Lapatinib/Capecitabine.","id":"FG002","title":"Lapatinib+Capecitabine"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"174"},{"groupId":"FG001","numSubjects":"64"},{"groupId":"FG002","numSubjects":"77"}],"type":"Progressive Disease"},{"reasons":[{"groupId":"FG000","numSubjects":"74"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"9"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"30"},{"groupId":"FG001","numSubjects":"11"},{"groupId":"FG002","numSubjects":"6"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"23"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"10"}],"type":"Clinical Progression"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Miscellaneous"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Protocol Deviation"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"3"}],"type":"Randomized But Not Treated"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"406"},{"groupId":"FG001","numSubjects":"91"},{"groupId":"FG002","numSubjects":"111"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"406"},{"groupId":"FG001","numSubjects":"91"},{"groupId":"FG002","numSubjects":"111"}],"type":"Randomized"},{"achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"3"}],"type":"Randomized But Not Treated"},{"achievements":[{"groupId":"FG000","numSubjects":"94"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"4"}],"comment":"Completed = Participants who are on-going study treatment as of 30 Jun 22, Not Completed = Participants who discontinued treatment and participants randomized but not treated.","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"312"},{"groupId":"FG001","numSubjects":"90"},{"groupId":"FG002","numSubjects":"107"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Participants in The Physician's Choice (TPC) group were randomized to 1 of the following 2 regimens: trastuzumab/capecitabine or lapatinib/capecitabine. As prespecified in the protocol, participants were assessed and reported separately per comparator arm for the disposition, baseline characteristics, and safety tables. For efficacy assessments, all participants in the TPC group were combined and assessed together.","recruitmentDetails":"A total of 608 participants were enrolled at study sites in 15 countries. Primary results reported is from first participant randomized up to data cut-off date of 30 Jun 2022. The results presented are based on primary analysis up to 46 months."}