Biomarkers of palbociclib response in hormone receptor-positive advanced breast cancer from the PARSIFAL trial

Currently, there are no clinically actionable biomarkers to predict patient to cyclin-dependent kinases 4 and 6 inhibitors (CDK4/6i) plus endocrine therapy for hormone receptor (HR)[+]/ human epidermal growth factor receptor 2 (HER2)[-] advanced breast cancer (ABC). Herein, we report an exploratory...

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Autores: Albanell Mestres, Joan, Gamez-Pozo, Angelo, Arteaga, Carlos L., Bellet, Meritxell, Rojo, Federico, González, Abel, Bellosillo Paricio, Beatriz, Serra, Violeta, Gener, Petra, Guerrero, José A., Shimizu, Eileen, Mancino, Mario, Rodríguez-Morató, Jose, 1987-, Mina, Leonardo, Pérez-García, José Manuel, Cortés, Javier, Llombart-Cussac, Antonio
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2025
País:España
Institución:Universitat Pompeu Fabra
Repositorio:Repositorio Digital de la UPF
OAI Identifier:oai:dnet:rdupf_______::8e4d613db10af0dedf121044e1130233
Acceso en línea:https://hdl.handle.net/10230/73198
http://dx.doi.org/10.1038/s41523-025-00777-0
Access Level:acceso abierto
Palabra clave:Mama--Càncer
Marcadors bioquímics
Oncologia
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spelling Biomarkers of palbociclib response in hormone receptor-positive advanced breast cancer from the PARSIFAL trialAlbanell Mestres, JoanGamez-Pozo, AngeloArteaga, Carlos L.Bellet, MeritxellRojo, FedericoGonzález, AbelBellosillo Paricio, BeatrizSerra, VioletaGener, PetraGuerrero, José A.Shimizu, EileenMancino, MarioRodríguez-Morató, Jose, 1987-Mina, LeonardoPérez-García, José ManuelCortés, JavierLlombart-Cussac, AntonioMama--CàncerMarcadors bioquímicsOncologiaCurrently, there are no clinically actionable biomarkers to predict patient to cyclin-dependent kinases 4 and 6 inhibitors (CDK4/6i) plus endocrine therapy for hormone receptor (HR)[+]/ human epidermal growth factor receptor 2 (HER2)[-] advanced breast cancer (ABC). Herein, we report an exploratory biomarker substudy (transFAL) from a subset of patients included in PARSIFAL, a phase II randomized clinical trial that evaluated first-line palbociclib plus fulvestrant or letrozole for HR[+]/HER2[-] ABC. No definitive biomarkers were discovered, however, worse outcomes were found with CDK6 postivity (p = 0.008), ER negativity (p = 0.008), high Ki67 (p = 0.04), and TP53 mutation (p = 0.04). ctDNA density (p = 0.036) and number of mutations (p = 0.033) at baseline were significantly higher for resistant patients. Our study reveals future directions to explore in the goal to determine biomarkers of response to CDK4/6i.Nature Research2026202620252026info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfhttps://hdl.handle.net/10230/73198http://dx.doi.org/10.1038/s41523-025-00777-0reponame:Repositorio Digital de la UPFinstname:Universitat Pompeu FabraInglésnpj Breast Cancer. 2025;11(1):59© The Author(s) 2025. Open Access This article is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License, which permits any non-commercial use, sharing, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if you modified the licensed material. You do not have permission under this licence to share adapted material derived from this article or parts of it. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc-nd/4.0/.http://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:dnet:rdupf_______::8e4d613db10af0dedf121044e11302332026-06-12T07:21:37Z
dc.title.none.fl_str_mv Biomarkers of palbociclib response in hormone receptor-positive advanced breast cancer from the PARSIFAL trial
title Biomarkers of palbociclib response in hormone receptor-positive advanced breast cancer from the PARSIFAL trial
spellingShingle Biomarkers of palbociclib response in hormone receptor-positive advanced breast cancer from the PARSIFAL trial
Albanell Mestres, Joan
Mama--Càncer
Marcadors bioquímics
Oncologia
title_short Biomarkers of palbociclib response in hormone receptor-positive advanced breast cancer from the PARSIFAL trial
title_full Biomarkers of palbociclib response in hormone receptor-positive advanced breast cancer from the PARSIFAL trial
title_fullStr Biomarkers of palbociclib response in hormone receptor-positive advanced breast cancer from the PARSIFAL trial
title_full_unstemmed Biomarkers of palbociclib response in hormone receptor-positive advanced breast cancer from the PARSIFAL trial
title_sort Biomarkers of palbociclib response in hormone receptor-positive advanced breast cancer from the PARSIFAL trial
dc.creator.none.fl_str_mv Albanell Mestres, Joan
Gamez-Pozo, Angelo
Arteaga, Carlos L.
Bellet, Meritxell
Rojo, Federico
González, Abel
Bellosillo Paricio, Beatriz
Serra, Violeta
Gener, Petra
Guerrero, José A.
Shimizu, Eileen
Mancino, Mario
Rodríguez-Morató, Jose, 1987-
Mina, Leonardo
Pérez-García, José Manuel
Cortés, Javier
Llombart-Cussac, Antonio
author Albanell Mestres, Joan
author_facet Albanell Mestres, Joan
Gamez-Pozo, Angelo
Arteaga, Carlos L.
Bellet, Meritxell
Rojo, Federico
González, Abel
Bellosillo Paricio, Beatriz
Serra, Violeta
Gener, Petra
Guerrero, José A.
Shimizu, Eileen
Mancino, Mario
Rodríguez-Morató, Jose, 1987-
Mina, Leonardo
Pérez-García, José Manuel
Cortés, Javier
Llombart-Cussac, Antonio
author_role author
author2 Gamez-Pozo, Angelo
Arteaga, Carlos L.
Bellet, Meritxell
Rojo, Federico
González, Abel
Bellosillo Paricio, Beatriz
Serra, Violeta
Gener, Petra
Guerrero, José A.
Shimizu, Eileen
Mancino, Mario
Rodríguez-Morató, Jose, 1987-
Mina, Leonardo
Pérez-García, José Manuel
Cortés, Javier
Llombart-Cussac, Antonio
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Mama--Càncer
Marcadors bioquímics
Oncologia
topic Mama--Càncer
Marcadors bioquímics
Oncologia
description Currently, there are no clinically actionable biomarkers to predict patient to cyclin-dependent kinases 4 and 6 inhibitors (CDK4/6i) plus endocrine therapy for hormone receptor (HR)[+]/ human epidermal growth factor receptor 2 (HER2)[-] advanced breast cancer (ABC). Herein, we report an exploratory biomarker substudy (transFAL) from a subset of patients included in PARSIFAL, a phase II randomized clinical trial that evaluated first-line palbociclib plus fulvestrant or letrozole for HR[+]/HER2[-] ABC. No definitive biomarkers were discovered, however, worse outcomes were found with CDK6 postivity (p = 0.008), ER negativity (p = 0.008), high Ki67 (p = 0.04), and TP53 mutation (p = 0.04). ctDNA density (p = 0.036) and number of mutations (p = 0.033) at baseline were significantly higher for resistant patients. Our study reveals future directions to explore in the goal to determine biomarkers of response to CDK4/6i.
publishDate 2025
dc.date.none.fl_str_mv 2025
2026
2026
2026
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/10230/73198
http://dx.doi.org/10.1038/s41523-025-00777-0
url https://hdl.handle.net/10230/73198
http://dx.doi.org/10.1038/s41523-025-00777-0
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv npj Breast Cancer. 2025;11(1):59
dc.rights.none.fl_str_mv http://creativecommons.org/licenses/by-nc-nd/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv http://creativecommons.org/licenses/by-nc-nd/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Nature Research
publisher.none.fl_str_mv Nature Research
dc.source.none.fl_str_mv reponame:Repositorio Digital de la UPF
instname:Universitat Pompeu Fabra
instname_str Universitat Pompeu Fabra
reponame_str Repositorio Digital de la UPF
collection Repositorio Digital de la UPF
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15.812429

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