{"groups":[{"description":"Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 milligrams per meter-squared (mg/m\\^2) every 21 days for four cycles followed by 5-fluorouracil 500 mg/m\\^2, epirubicin 75 mg/m\\^2, and cyclophosphamide 500 mg/m\\^2 (FEC) every 21 days for four cycles. Herceptin was administered as 8 milligrams per kilogram (mg/kg) on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the Treatment-Free Follow-Up (TFFU) Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the Survival Follow-Up (SFU) Period.","id":"FG000","title":"Herceptin IV + Chemotherapy"},{"description":"Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m\\^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-milligram (mg) fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.","id":"FG001","title":"Herceptin SC + Chemotherapy"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"15"}],"type":"Adverse Event or Intercurrent Illness"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"0"}],"type":"Insufficient Therapeutic Response"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"}],"type":"Violation of Selection Criteria"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"5"}],"type":"Participant Refusal/Withdrawal"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"11"}],"type":"Progression of Disease"},{"reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"5"}],"type":"Recurrence of Disease"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}],"type":"Other"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"299"},{"groupId":"FG001","numSubjects":"297"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"298"},{"groupId":"FG001","numSubjects":"297"}],"type":"Received Neoadjuvant Treatment"},{"achievements":[{"groupId":"FG000","numSubjects":"277"},{"groupId":"FG001","numSubjects":"273"}],"type":"Underwent Surgery"},{"achievements":[{"groupId":"FG000","numSubjects":"277"},{"groupId":"FG001","numSubjects":"274"}],"type":"Entered Adjuvant Treatment"},{"achievements":[{"groupId":"FG000","numSubjects":"257"},{"groupId":"FG001","numSubjects":"255"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"42"},{"groupId":"FG001","numSubjects":"42"}],"type":"NOT COMPLETED"}],"title":"Neoadjuvant/Adjuvant Treatment Periods"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"4"}],"type":"Adverse Event or Intercurrent Illness"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"1"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"11"}],"type":"Refused Treatment"},{"reasons":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"16"}],"type":"Failure to Return"},{"reasons":[{"groupId":"FG000","numSubjects":"63"},{"groupId":"FG001","numSubjects":"72"}],"type":"Recurrence of Disease"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"3"}],"type":"Other"}],"milestones":[{"achievements":[{"comment":"Participants could withdraw from the study entirely or advance directly to the TFFU or SFU Period.","groupId":"FG000","numSubjects":"265"},{"comment":"Participants could withdraw from the study entirely or advance directly to the TFFU or SFU Period.","groupId":"FG001","numSubjects":"268"}],"type":"STARTED"},{"achievements":[{"comment":"Includes participants who completed either 2 years of follow-up or 5 years of follow-up.","groupId":"FG000","numSubjects":"165"},{"comment":"Includes participants who completed either 2 years of follow-up or 5 years of follow-up.","groupId":"FG001","numSubjects":"161"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"100"},{"groupId":"FG001","numSubjects":"107"}],"type":"NOT COMPLETED"}],"title":"TFFU Period"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"44"},{"groupId":"FG001","numSubjects":"42"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"30"},{"groupId":"FG001","numSubjects":"28"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"8"}],"type":"Withdrawal by Subject"}],"milestones":[{"achievements":[{"comment":"Participants could withdraw from the study entirely or advance directly to the SFU Period.","groupId":"FG000","numSubjects":"118"},{"comment":"Participants could withdraw from the study entirely or advance directly to the SFU Period.","groupId":"FG001","numSubjects":"123"}],"type":"STARTED"},{"achievements":[{"comment":"Includes participants who completed either 2 years of follow-up or 5 years of follow-up.","groupId":"FG000","numSubjects":"40"},{"comment":"Includes participants who completed either 2 years of follow-up or 5 years of follow-up.","groupId":"FG001","numSubjects":"45"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"78"},{"groupId":"FG001","numSubjects":"78"}],"type":"NOT COMPLETED"}],"title":"SFU Period"}],"preAssignmentDetails":"A total of 833 participants were screened, out of which, 596 participants were enrolled into the study."}