{"groups":[{"description":"Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow intravenous (IV) infusion either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable adverse events (AEs).","id":"FG000","title":"Sacituzumab Govitecan"},{"description":"Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.\n\nEribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m\\^2 at North American sites and 1.23 mg/m\\^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m\\^2 and 0.67 mg/m\\^2 for North American and European sites, respectively).\n\nCapecitabine 1000 to 1250 mg/m\\^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months.\n\nGemcitabine 800 to 1200 mg/m\\^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months.\n\nVinorelbine 25 mg/m\\^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.","id":"FG001","title":"Treatment of Physician's Choice (TPC)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"197"},{"groupId":"FG001","numSubjects":"210"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"28"}],"type":"Withdrawal of Consent"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"4"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"55"},{"groupId":"FG001","numSubjects":"20"}],"type":"Sponsor's Decision"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"267"},{"groupId":"FG001","numSubjects":"262"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"258"},{"groupId":"FG001","numSubjects":"224"}],"type":"Enrolled and Treated"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"267"},{"groupId":"FG001","numSubjects":"262"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"730 participants were screened.","recruitmentDetails":"Participants were enrolled at study sites in Belgium, Canada, France, Germany, Spain, the United Kingdom, and the United States. The first participant was screened on 07 November 2017. The last study visit occurred on 08 December 2020."}