Rationale and trial design of NATALEE: a Phase III trial of adjuvant ribociclib + endocrine therapy versus endocrine therapy alone in patients with HR+/HER2- early breast cancer.

Dennis J SlamonPeter A FaschingSara Alsterlind HurvitzStephen ChiaJohn CrownMiguel MartínCarlos Henrique Barrios Aditya BardiaSeock-Ah ImDenise A YardleyMichael UntchChiun-Sheng HuangDaniil StroyakovskiyBinghe XuRebecca L MorooseSherene LoiFrances ViscoValerie Bee-MunteanuKaren AfenjarRodrigo FrescoTetiana TaranArunava ChakravarttyJuan Pablo ZarateAgnes LteifGabriel N Hortobagyi

Published in: Therapeutic advances in medical oncology (2023)

ClinicalTrials.gov identifier: NCT03701334 (https://clinicaltrials.gov/ct2/show/NCT03701334).

Keyphrases

phase iii
clinical trial
open label
phase ii
early breast cancer
double blind
placebo controlled
study protocol
computed tomography
early stage
stem cells
randomized controlled trial
magnetic resonance imaging
image quality
contrast enhanced
mesenchymal stem cells
smoking cessation