Outcomes
death, breast cancer-unrelated death, Breast Cancer, tumor
TUMOR, RECURRENCE, METASTASIS, BREAST CANCER, UTERINE CARCINOMA IN SITU, EVENT, SECONDARY
The primary endpoint was disease-free survival (DFS), defined as the time from the date of first registration until the date of the first event (recurrence in the ipsilateral preserved breast, ipsilateral chest wall or regional lymph node, or distant organ metastasis; secondary cancer without cutaneous basal cell carcinoma/spindle cell carcinoma and uterine carcinoma in situ; or all-cause death) in each group (CT+ET and ET). Secondary endpoints were the percentage of patients clinically responding to NET (CR or PR) and histological tumor response to NET, and DFS, distant DFS (DDFS), and overall survival (OS) in each group. Other secondary endpoints were the percentages of patients undergoing breast-conserving surgery, safety, health-related quality of life, and cost-effectiveness. DDFS was defined as the time to recurrence in distant organs such as the bone, liver, lung, brain excluding soft tissue or locoregional region, and breast cancer-unrelated death since randomization. OS was defined as the time from the date of primary enrollment until the date of death from any cause. Clinical staging, histological classification, and clinical response to NET were assessed in accordance with the General Rules for Clinical and Pathological Recording of Breast Cancer 15th Edition [