{"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":"FG000","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":"FG001","title":"Arm II (Early Local Therapy)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"10"}],"type":"Patient refusal"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"}],"type":"Disease progression"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Lack of insurance coverage for surgery"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"4"}],"type":"Reasons not reported"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"131"},{"groupId":"FG001","numSubjects":"125"}],"type":"STARTED"},{"achievements":[{"comment":"Patient continued their systemic therapy after randomization per their treating physician's discretion.","groupId":"FG000","numSubjects":"131"},{"comment":"Protocol therapy was early surgery and/or radiation therapy in this trial.","groupId":"FG001","numSubjects":"106"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"19"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"recruitmentDetails":"This study was activated on February 8, 2011, accrued its first patient on May 16, 2011, and accrual was terminated on July 23, 2015 with a final accrual of 390 patients on Step 1. Of the 390 patients enrolled, 256 of them were randomized to Step 2 to arm I and arm II."}