Outcomes
death
ADVERSE EVENT, RECURRENCE, METASTASIS, EVENT, INVASIVE CANCER, SECONDARY
The primary outcome was disease-free survival (DFS), defined as the time from randomization to occurrence of a new event, including local recurrence, regional relapse, distant metastasis, or death from any cause (excluding a second nonbreast invasive cancer). Patients alive without any predefined event were censored at the time of the last follow-up. The secondary outcomes included (1) overall survival (OS), defined as the time from randomization to death from any cause; (2) distant DFS (DDFS), defined as the time from randomization to the earliest distant metastasis or death from any cause; (3) DFS-s, defined as the time from randomization to occurrence of a new event, including local recurrence, regional relapse, distant metastasis, and second nonbreast invasive cancer; and (4) safety, which was assessed throughout the study treatment according to the Common Terminology Criteria for Adverse Events, version 4.0.