{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"11.5","value":"74.2"},{"groupId":"OG001","spread":"13.7","value":"68.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"66"}],"units":"Participants"}],"description":"The Functional Assessment of Cancer Therapy-Breast Trial Outcome Index (FACT-B TOI) was used as the primary HRQL endpoint, measured by the prorated aggregate score of the 24 items from the FACT-B (7 functional well-being, 7 physical well-being, 10 breast cancer specific items). The theoretical range of the prorated aggregate score was 0-96, higher scores indicate better quality of life.","dispersionType":"Standard Deviation","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":"MEAN","populationDescription":"All randomized patients at step 2 who reported quality of life data at 18 months after randomization","reportingStatus":"POSTED","timeFrame":"Assessed at 18 months after randomization","title":"Health-related Quality of Life (HRQL)","type":"SECONDARY","unitOfMeasure":"score on a scale"}