Efficacy and Safety Analysis of Nelipepimut-S Vaccine to Prevent Breast Cancer Recurrence: A Randomized, Multicenter, Phase III Clinical Trial.

Elizabeth A MittendorfBiao LuMichelle MeliskoJulie Price HillerIgor Bondarenko Adrian Murray BruntGrybach SergiiKatarina PetrakovaGeorge E Peoples

Published in: Clinical cancer research : an official journal of the American Association for Cancer Research (2019)

NP-S was well tolerated. There was no significant difference in DFS events between NP-S and placebo. Use of mandated annual scans and image-detected recurrence events hastened the interim analysis contributing to early trial termination.

Keyphrases

phase iii
clinical trial
double blind
open label
phase ii
placebo controlled
free survival
computed tomography
study protocol
cross sectional
randomized controlled trial
magnetic resonance