The impact of analysis methodology details on invasive breast cancer-free survival in randomized clinical trials

Full standardization of endpoints can only be achieved when the excluded components (like SPNBCs for IBCFS) of the endpoints are considered (and reported in detail!) as well. Different statistical approaches address different clinical questions. For the majority of clinical trials, reporting the total effect ('ignoring' SPNBCs) on IBCFS as well as invasive disease-free survival is strongly recommended.