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After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.","id":"BG000","title":"A: P+H IV Followed by PH FDC SC"},{"description":"In the Treatment Cross-Over Period of the study, participants randomized to Arm B first received the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles followed by pertuzumab intravenous (IV) and trastuzumab IV (P+H IV) administration for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.","id":"BG001","title":"B: PH FDC SC Followed by P+H IV"},{"description":"Total of all reporting groups","id":"BG002","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"11.6","value":"49.4"},{"groupId":"BG001","spread":"12.1","value":"48.2"},{"groupId":"BG002","spread":"11.8","value":"48.8"}]}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Age, Continuous","unitOfMeasure":"Years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"80"},{"groupId":"BG001","value":"80"},{"groupId":"BG002","value":"160"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"17"},{"groupId":"BG001","value":"21"},{"groupId":"BG002","value":"38"}],"title":"Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"59"},{"groupId":"BG001","value":"54"},{"groupId":"BG002","value":"113"}],"title":"Not Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"9"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Ethnicity (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"8"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"12"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"4"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"62"},{"groupId":"BG001","value":"67"},{"groupId":"BG002","value":"129"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"7"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"12.08","value":"67.36"},{"groupId":"BG001","spread":"14.15","value":"70.21"},{"groupId":"BG002","spread":"13.20","value":"68.78"}]}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Baseline Weight","unitOfMeasure":"kilograms (kg)"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"70"},{"groupId":"BG001","value":"70"},{"groupId":"BG002","value":"140"}],"title":"ECOG Peformance Status 0"},{"measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"20"}],"title":"ECOG Peformance Status 1"}]}],"description":"ECOG Performance Status: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework or office work.","paramType":"COUNT_OF_PARTICIPANTS","title":"Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"15"}],"title":"<4 Cycles"},{"measurements":[{"groupId":"BG000","value":"75"},{"groupId":"BG001","value":"70"},{"groupId":"BG002","value":"145"}],"title":"≥4 Cycles"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Number of Cycles of Prior Neoadjuvant Pertuzumab IV and Trastuzumab IV","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"55"},{"groupId":"BG001","value":"53"},{"groupId":"BG002","value":"108"}],"title":"Anthracyclines + Taxanes"},{"measurements":[{"groupId":"BG000","value":"22"},{"groupId":"BG001","value":"23"},{"groupId":"BG002","value":"45"}],"title":"Carboplatin + Taxanes"},{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"7"}],"title":"Taxanes Only"}]}],"description":"Participants were stratified at randomization according to prior neoadjuvant chemotherapy regimen, pathological complete response to prior neoadjuvant treatment, and hormone receptor status.","paramType":"COUNT_OF_PARTICIPANTS","title":"Prior Neoadjuvant Chemotherapy Regimen","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"52"},{"groupId":"BG001","value":"50"},{"groupId":"BG002","value":"102"}],"title":"pCR"},{"measurements":[{"groupId":"BG000","value":"28"},{"groupId":"BG001","value":"30"},{"groupId":"BG002","value":"58"}],"title":"Non-pCR"}]}],"description":"Participants were stratified at randomization according to prior neoadjuvant chemotherapy regimen, pathological complete response to prior neoadjuvant treatment, and hormone receptor status.","paramType":"COUNT_OF_PARTICIPANTS","title":"Pathological Complete Response (pCR) to Prior Neoadjuvant Treatment","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"53"},{"groupId":"BG001","value":"51"},{"groupId":"BG002","value":"104"}],"title":"Estrogen Receptor (ER)-Positive and/or Progesterone Receptor (PgR)-Positive"},{"measurements":[{"groupId":"BG000","value":"27"},{"groupId":"BG001","value":"29"},{"groupId":"BG002","value":"56"}],"title":"ER-Negative and PgR-Negative"}]}],"description":"Participants were stratified at randomization according to prior neoadjuvant chemotherapy regimen, pathological complete response to prior neoadjuvant treatment, and hormone receptor status.","paramType":"COUNT_OF_PARTICIPANTS","title":"Hormone Receptor Status","unitOfMeasure":"Participants"}],"populationDescription":"Intent-to-Treat (ITT) Population: includes all randomized participants, allocated to their randomized treatment arm, whether or not the assigned study treatment was received."}