A single-arm study design with non-inferiority and superiority time-to-event endpoints: a tool for proof-of-concept and de-intensification strategies in breast cancer

A single-arm study design with non-inferiority and superiority time-to-event endpoints: a tool for proof-of-concept and de-intensification strategies in breast cancer

De-escalation trials in oncology evaluate therapies that aim to improve the quality of life of patients with low-risk cancer by avoiding overtreatment. Non-inferiority randomized trials are commonly used to investigate de-intensified regimens with similar efficacy to that of standard regimens but wi...

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Bibliographic Details
Main Authors: Miguel Sampayo-Cordero, Bernat Miguel-Huguet, Andrea Malfettone, Elena López-Miranda, María Gion, Elena Abad, Daniel Alcalá-López, Jhudit Pérez-Escuredo, José Manuel Pérez-García, Antonio Llombart-Cussac, Javier Cortés
Format: Article
Language:English
Published: Frontiers Media S.A. 2023-07-01
Series:Frontiers in Oncology
Subjects:
time-to-event
non-inferiority
single-arm
phase II
clinical trial
superiority
Online Access:https://www.frontiersin.org/articles/10.3389/fonc.2023.1048242/full

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https://www.frontiersin.org/articles/10.3389/fonc.2023.1048242/full

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