%0 Randomized Controlled Trial
%T Management of second ipsilateral breast tumor event: An advocacy for a randomized trial.
%A Hannoun-Lévi JM
%A Savignoni A
%A Féron JG
%A Malhaire C
%A Ezzili C
%A Brédart A
%A Loap P
%A Kirova Y
%J Cancer Radiother
%V 28
%N 2
%D 2024 Apr 11
%M 38216433
%F 1.217
%R 10.1016/j.canrad.2023.11.001
%X For a second ipsilateral breast tumor event, salvage mastectomy is the standard of care while second conservative treatment is a possible option. However, level 1 proofs are missing, leading to perform salvage mastectomy for patients who could receive second conservative treatment and consequently avoid psychological/quality of life salvage mastectomy deleterious impacts. A phase 3 randomized trial comparing salvage mastectomy to second conservative treatment is needed. Here we discuss what would be to us the optimal design of such trial to confirm the non-inferiority between the two salvage options, with a focus on methodological aspects in terms of patient characteristics and statistical issues.