Palbociclib and trastuzumab for HER2-positive metastatic breast cancer: final overall survival results of cohort A and B of SOLTI-1303-PATRICIA trial

This work was supported by a grant from Pfizer (no grant number), which also provided palbociclib. Pfizer had no role in the management of this trial. All decisions and responsibilities for the trial were managed solely by the sponsor, the SOLTI Group.

Detalhes bibliográficos
Autores: Pascual, T., Villacampa Javierre, Guillermo, Oliveira, Mafalda, Escrivá-de-Romaní, S., Pernas, S., Paré, L., Adamo, Barbara, Cortés, J., Perelló, A., Galán, M., Melé, Mireia, Villanueva, L., González-Rodríguez, Marta, Tolosa, Pablo, Gonzalez-Farre, Blanca, Galván, Patricia, Canes, Jordi, Nuciforo, Paolo, Ferrero-Cafiero, Juan Manuel, Gonzàlez Farré, Xavier, Villagrasa-Gonzalez, Patricia, Prat, Aleix, Ciruelos, Eva
Formato: artículo
Fecha de publicación:2025
País:España
Recursos:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repositorio:Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:oai:recercat.cat:20.500.12328/5114
Acesso em linha:http://hdl.handle.net/20.500.12328/5114
https://dx.doi.org/10.1016/j.esmoop.2025.105572
Access Level:acceso abierto
Palavra-chave:Metastatic breast cancer
HR-positive/HERC-positive
Palbociclib
Trastuzumab
Biomarkers
Gene expression profiling
Cáncer de mama metastásico
Biomarcadores
Perfil de expresión genética
Càncer de mama metastàsico
Biomarcadors
Perfil d'expressió genètica
616
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oai_identifier_str oai:recercat.cat:20.500.12328/5114
network_acronym_str ES
network_name_str España
repository_id_str
spelling Palbociclib and trastuzumab for HER2-positive metastatic breast cancer: final overall survival results of cohort A and B of SOLTI-1303-PATRICIA trialPascual, T.Villacampa Javierre, GuillermoOliveira, MafaldaEscrivá-de-Romaní, S.Pernas, S.Paré, L.Adamo, BarbaraCortés, J.Perelló, A.Galán, M.Melé, MireiaVillanueva, L.González-Rodríguez, MartaTolosa, PabloGonzalez-Farre, BlancaGalván, PatriciaCanes, JordiNuciforo, PaoloFerrero-Cafiero, Juan ManuelGonzàlez Farré, XavierVillagrasa-Gonzalez, PatriciaPrat, AleixCiruelos, EvaMetastatic breast cancerHR-positive/HERC-positivePalbociclibTrastuzumabBiomarkersGene expression profilingCáncer de mama metastásicoBiomarcadoresPerfil de expresión genéticaCàncer de mama metastàsicoBiomarcadorsPerfil d'expressió genètica616This work was supported by a grant from Pfizer (no grant number), which also provided palbociclib. Pfizer had no role in the management of this trial. All decisions and responsibilities for the trial were managed solely by the sponsor, the SOLTI Group.Background: The SOLTI-1303-PATRICIA trial (NCT02448420) is a phase II study investigating palbociclib and trastuzumab, with or without endocrine therapy, in hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC). This manuscript presents final overall survival (OS) results and biomarker analyses. Patients and methods: Patients previously treated with trastuzumab and two to four regimens were eligible. For estrogen receptor (ER)-negative disease (cohort A), patients received palbociclib and trastuzumab. For ER-positive disease, patients were randomized 1 : 1 to cohort B1 (no additional therapy) or B2 (letrozole). OS and long-term progression-free survival (PFS) were pre-defined secondary endpoints. Kaplan—Meier curves and stratified Cox models were used. Results: Among 71 patients, median OS was 29.8 months [95% confidence interval (CI) 20.9-38.0 months]; 4-year OS rates were 13.3% (A), 35.7% (B1), and 32.3% (B2). PAM50 luminal subtypes showed better OS than non-luminal subtypes (38.0 versus 26.6 months). Exploratory biomarker analyses found luminal-related genes associated with better long-term survival, while basal and proliferation-related genes were linked to resistance. Higher luminal A, luminal B, and previously reported chemo-endocrine scores correlated with favorable prognoses. Conclusions: These findings highlight the relevance of gene expression profiling in HER2-positive breast cancer and support biomarker-driven patient selection. Long-term PATRICIA results validate the potential of non-chemotherapybased approaches in HR-positive/HER2-positive MBC.info:eu-repo/semantics/publishedVersionElsevier2025info:eu-repo/semantics/article7http://hdl.handle.net/20.500.12328/5114https://dx.doi.org/10.1016/j.esmoop.2025.105572reponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésESMO Open10;9© 2025 The Author(s). Published by Elsevier Ltd on behalf of European Society for Medical Oncology. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).http://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:recercat.cat:20.500.12328/51142026-05-29T05:05:01Z
dc.title.none.fl_str_mv Palbociclib and trastuzumab for HER2-positive metastatic breast cancer: final overall survival results of cohort A and B of SOLTI-1303-PATRICIA trial
title Palbociclib and trastuzumab for HER2-positive metastatic breast cancer: final overall survival results of cohort A and B of SOLTI-1303-PATRICIA trial
spellingShingle Palbociclib and trastuzumab for HER2-positive metastatic breast cancer: final overall survival results of cohort A and B of SOLTI-1303-PATRICIA trial
Pascual, T.
Metastatic breast cancer
HR-positive/HERC-positive
Palbociclib
Trastuzumab
Biomarkers
Gene expression profiling
Cáncer de mama metastásico
Biomarcadores
Perfil de expresión genética
Càncer de mama metastàsico
Biomarcadors
Perfil d'expressió genètica
616
title_short Palbociclib and trastuzumab for HER2-positive metastatic breast cancer: final overall survival results of cohort A and B of SOLTI-1303-PATRICIA trial
title_full Palbociclib and trastuzumab for HER2-positive metastatic breast cancer: final overall survival results of cohort A and B of SOLTI-1303-PATRICIA trial
title_fullStr Palbociclib and trastuzumab for HER2-positive metastatic breast cancer: final overall survival results of cohort A and B of SOLTI-1303-PATRICIA trial
title_full_unstemmed Palbociclib and trastuzumab for HER2-positive metastatic breast cancer: final overall survival results of cohort A and B of SOLTI-1303-PATRICIA trial
title_sort Palbociclib and trastuzumab for HER2-positive metastatic breast cancer: final overall survival results of cohort A and B of SOLTI-1303-PATRICIA trial
dc.creator.none.fl_str_mv Pascual, T.
Villacampa Javierre, Guillermo
Oliveira, Mafalda
Escrivá-de-Romaní, S.
Pernas, S.
Paré, L.
Adamo, Barbara
Cortés, J.
Perelló, A.
Galán, M.
Melé, Mireia
Villanueva, L.
González-Rodríguez, Marta
Tolosa, Pablo
Gonzalez-Farre, Blanca
Galván, Patricia
Canes, Jordi
Nuciforo, Paolo
Ferrero-Cafiero, Juan Manuel
Gonzàlez Farré, Xavier
Villagrasa-Gonzalez, Patricia
Prat, Aleix
Ciruelos, Eva
author Pascual, T.
author_facet Pascual, T.
Villacampa Javierre, Guillermo
Oliveira, Mafalda
Escrivá-de-Romaní, S.
Pernas, S.
Paré, L.
Adamo, Barbara
Cortés, J.
Perelló, A.
Galán, M.
Melé, Mireia
Villanueva, L.
González-Rodríguez, Marta
Tolosa, Pablo
Gonzalez-Farre, Blanca
Galván, Patricia
Canes, Jordi
Nuciforo, Paolo
Ferrero-Cafiero, Juan Manuel
Gonzàlez Farré, Xavier
Villagrasa-Gonzalez, Patricia
Prat, Aleix
Ciruelos, Eva
author_role author
author2 Villacampa Javierre, Guillermo
Oliveira, Mafalda
Escrivá-de-Romaní, S.
Pernas, S.
Paré, L.
Adamo, Barbara
Cortés, J.
Perelló, A.
Galán, M.
Melé, Mireia
Villanueva, L.
González-Rodríguez, Marta
Tolosa, Pablo
Gonzalez-Farre, Blanca
Galván, Patricia
Canes, Jordi
Nuciforo, Paolo
Ferrero-Cafiero, Juan Manuel
Gonzàlez Farré, Xavier
Villagrasa-Gonzalez, Patricia
Prat, Aleix
Ciruelos, Eva
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Metastatic breast cancer
HR-positive/HERC-positive
Palbociclib
Trastuzumab
Biomarkers
Gene expression profiling
Cáncer de mama metastásico
Biomarcadores
Perfil de expresión genética
Càncer de mama metastàsico
Biomarcadors
Perfil d'expressió genètica
616
topic Metastatic breast cancer
HR-positive/HERC-positive
Palbociclib
Trastuzumab
Biomarkers
Gene expression profiling
Cáncer de mama metastásico
Biomarcadores
Perfil de expresión genética
Càncer de mama metastàsico
Biomarcadors
Perfil d'expressió genètica
616
description This work was supported by a grant from Pfizer (no grant number), which also provided palbociclib. Pfizer had no role in the management of this trial. All decisions and responsibilities for the trial were managed solely by the sponsor, the SOLTI Group.
publishDate 2025
dc.date.none.fl_str_mv 2025
dc.type.none.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv http://hdl.handle.net/20.500.12328/5114
https://dx.doi.org/10.1016/j.esmoop.2025.105572
url http://hdl.handle.net/20.500.12328/5114
https://dx.doi.org/10.1016/j.esmoop.2025.105572
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv ESMO Open
10;9
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 7
dc.publisher.none.fl_str_mv Elsevier
publisher.none.fl_str_mv Elsevier
dc.source.none.fl_str_mv reponame:Recercat. Dipósit de la Recerca de Catalunya
instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
instname_str Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
reponame_str Recercat. Dipósit de la Recerca de Catalunya
collection Recercat. Dipósit de la Recerca de Catalunya
repository.name.fl_str_mv
repository.mail.fl_str_mv
_version_ 1869406608765747200
score 15,198674

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