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Study record managers: refer to the Data Element Definitions if submitting registration or information. TTDR is defined as the time from date of randomization until the first occurrence of distant recurrence or death from breast cancer. Competing events include distant recurrence at other sites as the first distant recurrence and death from any cause prior to distant recurrence. Distant Disease-free Survival DDFS in Neratinib Arm Compared to Placebo Arm at Year 5 [ Time Frame: From randomization until time of event up to 5 years ] Distant disease-free survival time is defined as the time from date of randomization until the first occurrence of distant recurrence or death from any cause. Talk with your doctor and family members or friends about deciding to a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below.

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