{"groups":[{"description":"Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy were randomized to receive an intravenous infusion of DS8201a (initial dose of 5.4 mg/kg) over approximately 90 minutes. If there was no infusion-related reaction (IRR), T-DXd doses after the initial dose of 5.4 mg/kg were infused over a minimum of 30 minutes.","id":"FG000","title":"Trastuzumab Deruxtecan (T-DXd)"},{"description":"Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to a physician's choice (capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel) in which the dose, regimen, administration, and dose modification followed the label approved in the country of drug administration or the National Comprehensive Cancer Network guidelines.","id":"FG001","title":"Physician's Choice"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"220"},{"groupId":"FG001","numSubjects":"130"}],"type":"Progressive disease as per RECIST v1.1"},{"reasons":[{"groupId":"FG000","numSubjects":"60"},{"groupId":"FG001","numSubjects":"14"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"11"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"8"}],"type":"Clinical progression by investigator"},{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"2"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"3"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}],"type":"Other"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"12"}],"type":"Randomized, but not treated"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"373"},{"groupId":"FG001","numSubjects":"184"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"373"},{"groupId":"FG001","numSubjects":"184"}],"type":"Full Analysis Set (All Randomized Patients)"},{"achievements":[{"groupId":"FG000","numSubjects":"371"},{"groupId":"FG001","numSubjects":"172"}],"type":"Safety Analysis Set (All Randomized Patients Who Received at Least 1 Dose of Study Treatment)"},{"achievements":[{"groupId":"FG000","numSubjects":"58"},{"groupId":"FG001","numSubjects":"3"}],"comment":"Ongoing as of 11 Jan 2022","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"315"},{"groupId":"FG001","numSubjects":"181"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"All participants had been previously treated with at least 1 and no more than 2 prior lines of chemotherapy in the recurrent or metastatic setting. The treatment chosen for the Physician's Choice arm was based on the label approved in the country of drug administration. The Physician's Choice group was combined to ensure an appropriate sample size for the comparator group.","recruitmentDetails":"A total of 557 participants were enrolled and randomized to treatment at 161 study sites in the United States (27 study sites), Japan (18 sites), France (16 sites), China (15 sites), Italy (13 sites), Spain (12 sites), Greece (8 sites), Portugal (8 sites), Republic of Korea (8 sites), Israel (6 sites), Switzerland (6 sites), Austria (4 sites), Belgium (4 sites), Russia (3 sites), Sweden (3 sites), Taiwan (3 sites), Unted Kingdom (3 sites), Canada (2 sites), and Hungary (2 sites)."}