{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"10.7","upperLimit":"24.4","value":"16.3"},{"groupId":"OG001","lowerLimit":"31.8","upperLimit":"49.1","value":"39.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"131"},{"groupId":"OG001","value":"125"}],"units":"Participants"}],"description":"For patients in arm II (early local therapy), time to locoregional recurrence was defined as time from randomization to date of locoregional recurrence; for patients in arm A (continued systemic therapy), time to locoregional progression was defined as time from randomization to date of locoregional progression. In this study, locoregional recurrence was defined as the new development or clinically significant increase in size of any supraclavicular, infraclavicular, internal mammary or axillary adenopathy or chest wall disease or invasive in-breast recurrence for patients on arm B; for patients on arm A, locoregional progression was defined as the development of symptoms leading to a decision for local therapy. Locoregional recurrence/progression and distant progression were followed separately in the study, and the occurrence of one did not preclude the other getting reported. 3-year cumulative incidence of locoregional recurrence/progression was estimated.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients receive standard palliative therapy, if needed, to address symptoms such as tumor ulceration, pain, bulky adenopathy causing arm symptoms, and other similar situations. Therapy may consist of radiotherapy alone, surgery alone, or a combination of both.\n\npalliative surgery: Undergo standard palliative surgery\n\npalliative radiation therapy: Undergo standard palliative radiotherapy","id":"OG000","title":"Arm I (Continued Systemic Therapy)"},{"description":"Patients undergo surgery comprising breast-conserving therapy (BCT) or total mastectomy according to patient and treating physician preference. Surgery is to occur no later than 10 weeks after completion of 32 weeks of systemic therapy. Free surgical margins must be achieved with re-excision or mastectomy for patients undergoing BCT. After completion of BCT, patients undergo radiotherapy once a day, 5 days per week. Patients who had mastectomy undergo radiotherapy at the discretion of treating physician.\n\ntherapeutic conventional surgery: Undergo early surgery\n\nradiation therapy: Undergo radiotherapy","id":"OG001","title":"Arm II (Early Local Therapy)"}],"paramType":"NUMBER","populationDescription":"All randomized patients at step 2","reportingStatus":"POSTED","timeFrame":"Assessed at baseline, then every 3 months within 2 years and every 6 months between 2-5 years, up to 5 years","title":"3-year Cumulative Incidence of Locoregional Recurrence/Progression","type":"SECONDARY","unitOfMeasure":"percentage of participants"}