TAM01 study [
death, TAM01
SECONDARY, RECURRENCE, METASTASES
The TAM01 trial is a randomized multicenter open-label superiority phase 3 trial that assessed the effects of extended tamoxifen treatment on recurrence and mortality in early BC, the design and conduct of which have been described elsewhere [TAM01 trial’s primary endpoint was DFS while OS was a secondary. DFS was defined as the time elapsed between inclusion and local or regional recurrence, distant metastases or death from any cause. Patients who did not experience any recurrence, metastases or died were censored at date of last news. OS was defined as the time elapsed between inclusion and death, regardless of its cause. Patients who were still alive (including those lost to follow-up) were censored at the last known date they were alive. In the original trial publication [Patients from the LT arm and patients from the ST arm, with prolonged exposure after treatment, were therefore, allocated according to true tamoxifen exposure to a cohort of “12 years tamoxifen (extended group)”, while patients from the ST arm or LT arm who discontinued at randomization were included in a cohort of “2–3 years tamoxifen (short-term group)”.The revised definition of invasive DFS (iDFS) reported by DATECAN initiative [