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

dc.contributor
Institut Català de la Salut
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[Pascual T] SOLTI Cancer Research Group, Barcelona, Spain. Department of Medical Oncology, Cancer Institute and Blood Disorders, Hospital Clínic de Barcelona, Barcelona, Spain. Translational Genomics and Targeted Therapies in Solid Tumors, August Pi I Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain. Medicine Department, University of Barcelona, Barcelona, Spain. [Villacampa G] SOLTI Cancer Research Group, Barcelona, Spain. Statistics Unit, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Oliveira M, Escrivá-de-Romaní S] SOLTI Cancer Research Group, Barcelona, Spain. Servei d’Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Breast Cancer Group, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Pernas S] SOLTI Cancer Research Group, Barcelona, Spain. Institut Catala d’Oncologia-IDIBELL, L’Hospitalet, Barcelona, Spain. [Paré L] SOLTI Cancer Research Group, Barcelona, Spain. Reveal Genomics, Barcelona, Spain. [Nuciforo P] Molecular Oncology Group, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain
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Vall d'Hebron Barcelona Hospital Campus
dc.contributor.author
PERNAS SIMON, SONIA
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Pascual, Tomás
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Villacampa Javierre, Guillermo
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Oliveira, Mafalda
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Escriva de Romani, Santiago
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Paré, Laia
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Nuciforo, Paolo
dc.date.accessioned
2025-11-05T18:22:38Z
dc.date.available
2025-11-05T18:22:38Z
dc.date.issued
2025-11-04T12:08:38Z
dc.date.issued
2025-11-04T12:08:38Z
dc.date.issued
2025-09
dc.identifier
Pascual T, Villacampa G, Oliveira M, Escrivá-de-Romaní S, Pernas S, Paré L, et al. Palbociclib and trastuzumab for HER2-positive metastatic breast cancer: final overall survival results of cohort A and B of SOLTI-1303-PATRICIA trial. ESMO Open. 2025 Sep;10(9):105572.
dc.identifier
2059-7029
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http://hdl.handle.net/11351/14011
dc.identifier
10.1016/j.esmoop.2025.105572
dc.identifier
40896880
dc.identifier
001568022300003
dc.identifier.uri
http://hdl.handle.net/11351/14011
dc.description.abstract
HR-positive/HER2-positive; Biomarkers; Gene expression profiling
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HR-positiu/HER2-positiu; Biomarcadors; Perfils d'expressió gènica
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HR-positivo/HER2-positivo; Biomarcadores; Perfil de expresión génica
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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-chemotherapy-based approaches in HR-positive/HER2-positive MBC.
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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.
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application/pdf
dc.language
eng
dc.publisher
Elsevier
dc.relation
ESMO Open;10(9)
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https://doi.org/10.1016/j.esmoop.2025.105572
dc.rights
Attribution-NonCommercial-NoDerivatives 4.0 International
dc.rights
http://creativecommons.org/licenses/by-nc-nd/4.0/
dc.rights
info:eu-repo/semantics/openAccess
dc.source
Scientia
dc.subject
Metàstasi
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Mama - Càncer - Tractament
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Quimioteràpia combinada
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Marcadors tumorals
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DISEASES::Neoplasms::Neoplasms by Site::Breast Neoplasms
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Other subheadings::Other subheadings::Other subheadings::/drug therapy
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ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols
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DISEASES::Neoplasms::Neoplastic Processes::Neoplasm Metastasis
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CHEMICALS AND DRUGS::Biological Factors::Biomarkers::Biomarkers, Tumor
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ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias de la mama
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Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
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TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada
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ENFERMEDADES::neoplasias::procesos neoplásicos::metástasis neoplásica
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COMPUESTOS QUÍMICOS Y DROGAS::factores biológicos::biomarcadores::marcadores tumorales
dc.title
Palbociclib and trastuzumab for HER2-positive metastatic breast cancer: final overall survival results of cohort A and B of SOLTI-1303-PATRICIA trial
dc.type
info:eu-repo/semantics/article
dc.type
info:eu-repo/semantics/publishedVersion


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