Randomised, open-label, multicentric phase III trial to evaluate the safety and efficacy of palbociclib in combination with endocrine therapy, guided by ESR1 mutation monitoring in oestrogen receptor-positive, HER2-negative metastatic breast cancer patien

Fiche publication

Date publication

mars 2022

Journal

BMJ open

Auteurs

Membres identifiés du Cancéropôle Est :
Dr ARNOULD Laurent

Tous les auteurs :
Berger F, Marce M, Delaloge S, Hardy-Bessard AC, Bachelot T, Bièche I, Pradines A, De La Motte Rouge T, Canon JL, André F, Arnould L, Clatot F, Lemonnier J, Marques S, Bidard FC,

Lien Pubmed

https://www.ncbi.nlm.nih.gov/pubmed/35241469

Résumé

The combination of a CDK4/6 inhibitor with an aromatase inhibitor (AI) has recently become the gold standard for AI-sensitive first line treatment of oestrogen receptor-positive (ER+) HER2-negative (HER2-) advanced breast cancer. However, most patients receiving this combination will ultimately progress and require further therapies.Several studies have demonstrated that the onset of a gene mutation lead to AIs resistance in the advanced setting. mutations can be detected in circulating tumour DNA (ctDNA) using a digital PCR assay. Our study aims to prove the clinical efficacy of periodic monitoring for emerging or rise of mutations in ctDNA to trigger an early change from AI plus palbociclib to fulvestrant plus palbociclib treatment while assessing global safety.