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 patients: study design of PADA-1

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 patients: study design of PADA-1

Introduction 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 ul...

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Main Authors: C Cheneau, S Barthier, J Lemonnier, Fabrice Andre, C Dubot, L Teixeira, A Escande, T De La Motte Rouge, T Petit, L Arnould, Laurent Arnould, Suzette Delaloge, Jerome Lemonnier, A Marti, L Stefani, F Berger, C Levy, P Barthelemy, S Nguyen, M Gardner, A Lortholary, François-Clément Bidard, J Plaza, L Joly, Thibault de la Motte Rouge, F Andre, I Bièche, C Alleaume, R Sabatier, B Lucas, Ivan Bieche, O Derbel, L Venat-Bouvet, F Del Piano, Florian Clatot, Anne-Claire Hardy-Bessard, Frédérique Berger, Margaux Marce, Thomas Bachelot, Anne Pradines, Jean-Luc Canon, Sandrine Marques, M Achille, H Ammarguellat, O Arsene, T Bachelot, C Bernard-Marty, F-C Bidard, N Bonichon-Lamichhane, N Bonnin, R Bouaita, A Boudrant, V-A Brunel, C Chakiba, F Clatot, F Dalenc, A De Gramont, L Deiana, C Delbaldo, V Delecroix, H Desclos, V D'Hondt, N Dohollou, J-M Ferrero, C Foa, J-S Frenel, C Garnier Tixidre, D Genet, O Gisserot, M Gozy, C Greilsamer, J Grenier, F Guinet, A-C Hardy-Bessard, J-P Jacquin, E Lachaier, S Ladoire, A-P Laurenty, R Le Scodan, N Leduc, E Legouffe, C Levache, F Lorchel, N Marques, J Medioni, A Melis, D Mille, D Mollon, L Moreau, I Moullet, M-A Mouret-Reynier, A Najem, H Orfeuvre, J-F Paitel, B Pistilli, C Riedl, P Soulie, D Spaeth, F Trouboul, C Valmar, H Vegas, A Zannetti, FC Bidard, S Delaloge, A Pradines, JL Canon, S Marques
Format: Article
Language:English
Published: BMJ Publishing Group 2022-03-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/12/3/e055821.full

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https://bmjopen.bmj.com/content/12/3/e055821.full

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