Has partial breast irradiation by IORT or brachytherapy been prematurely introduced into the clinic?

In contrast to most new oncology treatments, wide clinical introduction of partial breast irradiation (PBI) is not based on level A trial evidence. Despite promising phase I/II data, new reports based upon large cohorts of patients mention more recurrences and/or complications from PBI compared with whole breast irradiation (WBI), necessitating more careful selection of patients for PBI while awaiting long term results of major clinical trials. In an attempt to improve this we give preoperative PBI within a prospective trial.