A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF ADJUVANT ATEZOLIZUMAB OR PLACEBO AND TRASTUZUMAB EMTANSINE FOR HER2-POSITIVE BREAST CANCER AT HIGH RISK OF RECURRENCE FOLLOWING PREOPERATIVE THERAPY

简要总结

主要结局

次要结局

• 1. Invasive disease-free survival including second primary non breast invasive cancer
• 2. IDFS, in the PD-L1-positive and the PD-L1-negative population (defined as all randomized patients from the ITT population with a centrally assessed PD-L1-positive [i.e., PD-L1 status of IC1/2/3] or PD-L1-negative status [i.e.,PD-L1 status of IC0] at randomization as per corresponding stratification factors recorded in the IWRS).
• 3. Disease-free survival
• 4 . Overall survival
• 5 . Distant recurrence-free interval
• 6. The proportion of patients in each arm with clinically meaningful deterioration in GHS/QoL physical, role, and cognitive function as measured by scales of the European Organisation for Research and Treatment of Cancer quality of life questionnaire for cancer (EORTC QLQ C30)
• 7. Mean absolute scores and mean change from baseline scores in GHS/QoL, physical, role, and cognitive function, as assessed using the EORTC QLQ C30
• 9. Maximum and minimum serum concentrations for atezolizumab and trastuzumab emtansine
• 8. Incidence and severity of adverse events
• 10. Incidence of antidrug antibodies (ADAs) to atezolizumab and to trastuzumab emtansine at specified timepoints