{"groups":[{"description":"Participants received SPI-2012 13.2 milligram (mg)/0.6 milliliter (mL) (3.6 mg Granulocyte Colony-Stimulating Factor \\[G-CSF\\]) fixed-dose subcutaneous (SC) injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy was administered on Day 1 of each cycle and included Docetaxel 75 mg/m\\^2 intravenous (IV) infusion and Cyclophosphamide 600 mg/m\\^2 IV infusion per institute's standard of care.","id":"FG000","title":"Arm 1: SPI-2012 and Docetaxel + Cyclophosphamide (TC)"},{"description":"Participants received pegfilgrastim 6 mg SC injection once per cycle on Day 2 of each cycle up to Cycle 4 (each cycle was 21 days), approximately 24-26 hours after TC chemotherapy administration. TC chemotherapy on Day 1 of each cycle included Docetaxel 75 mg/m\\^2 IV infusion and Cyclophosphamide 600 mg/m\\^2 IV infusion per institute's standard of care.","id":"FG001","title":"Arm 2: Pegfilgrastim and Docetaxel + Cyclophosphamide (TC)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"12"}],"type":"Initiation of Non-Protocol Therapy for Breast Cancer"},{"reasons":[{"groupId":"FG000","numSubjects":"25"},{"groupId":"FG001","numSubjects":"19"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"10"}],"type":"Treatment with Additional Myeloid Growth Factors During Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"10"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"4"}],"type":"Investigator Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}],"type":"Sponsor decision"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"7"}],"type":"Reason not Specified"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"196"},{"groupId":"FG001","numSubjects":"210"}],"type":"STARTED"},{"achievements":[{"comment":"One participant was randomized to the Arm 2: Pegfilgrastim and TC but was inadvertently administered SPI-2012 on Cycle 1, Day 2 and was included in the Arm 1: SPI-2012 and TC for the Safety Population.","groupId":"FG000","numSubjects":"197"},{"groupId":"FG001","numSubjects":"208"}],"comment":"Safety Population included all participants who had received at least one dose of any protocol specified drug (TC, SPI-2012, or pegfilgrastim).","type":"Safety Population"},{"achievements":[{"groupId":"FG000","numSubjects":"142"},{"groupId":"FG001","numSubjects":"145"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"54"},{"groupId":"FG001","numSubjects":"65"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"recruitmentDetails":"Participants were enrolled from 19 Jan 2016 to 31 Oct 2018. A total of 406 participants were randomized in the study."}