The study and design end points have been described else-where.9 (link),10 (link) Briefly, after stratification based on age, hormone receptor status, and tumor size, patients with 1 or 2 sentinel nodes with metastases detected by hematoxylin and eosin stain were randomized to no further axillary-specific treatment including no axillary third-field irradiation (SLND alone group) or completion ALND (ALND group). Patients were assessed for disease recurrence with a history and physical examination every 6 months for the first 36 months and yearly thereafter. Annual mammography was required; other testing was based on individual symptoms or by investigator preference.
Follow-up was planned for 10 years. The primary study end point was overall survival, which was defined as the time from randomization until death from any cause. Disease-free survival, which was defined as the time from randomization to death or first breast cancer recurrence, was a secondary end point along with morbidity and locoregional recurrence. Locoregional recurrence was defined as a tumor in the breast or in ipsilateral axillary, internal mammary, subclavicular, or supraclavicular nodes. All other disease sites were defined as distant metastases. Secondary end points have been reported.6 (link),13 (link)
Follow-up was planned for 10 years. The primary study end point was overall survival, which was defined as the time from randomization until death from any cause. Disease-free survival, which was defined as the time from randomization to death or first breast cancer recurrence, was a secondary end point along with morbidity and locoregional recurrence. Locoregional recurrence was defined as a tumor in the breast or in ipsilateral axillary, internal mammary, subclavicular, or supraclavicular nodes. All other disease sites were defined as distant metastases. Secondary end points have been reported.6 (link),13 (link)
