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936423.pdf (1.08 MB)

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2026-04-08

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cc-by (c) Alexios Matikas et al., 2026
Si us plau utilitzeu sempre aquest identificador per citar o enllaçar aquest document: https://hdl.handle.net/2445/229249

Neoadjuvant palbociclib and endocrine therapy versus chemotherapy in ER + /HER2- breast cancer: a randomized phase II trial

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https://doi.org/10.1038/s41467-026-71452-6

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n PREDIX LumB patients with estrogen receptor positive and human epidermal growth factor receptor negative (ER + /HER2-) breast cancer > 20 mm and/or with lymph node metastasis were randomized 1:1 to receive either paclitaxel weekly for 12 weeks followed by palbociclib and endocrine therapy for 12 weeks (arm A), or the reverse sequence (arm B). Primary endpoint is objective radiologic response at 12 weeks (ORR12), and key secondary endpoints are ORR24, pathologic complete response, event-free survival, safety and correlative studies of tissue and circulating biomarkers. Whole exome sequencing and RNA sequencing were performed on baseline fresh frozen tissue samples. In total, 179 patients comprise the intention-to-treat population. There is no statistically significant difference between the two arms in ORR12 (59% vs 45%, p = 0.058). An exploratory gene expression analysis identified differentially expressed genes and gene sets between responders and non-responders at 12 weeks. A predictive signature, CDKPredX, comprising 31 genes related to proliferation, ER signaling and immune activity was developed to identify patients resistant to chemotherapy but responding to palbociclib plus endocrine therapy (pinteraction=0.03). The predictive signature was independently validated in the CORALLEEN trial (pinteraction=0.048). Clinicaltrials.gov identifier: NCT02603679

Matèries

Hormonoteràpia, Marcadors bioquímics, Càncer de mama, Quimioteràpia

Matèries (anglès)

Hormone therapy, Biochemical markers, Breast cancer, Chemotherapy

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Articles publicats en revistes (Medicina)
Articles publicats en revistes (IDIBAPS: Institut d'investigacions Biomèdiques August Pi i Sunyer)

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PASCUAL, Tomás, GAVILÁ, Joaquín, PRAT APARICIO, Aleix, PEROU, Charles m., BRANDBERG, Yvonne, BERGH, Jonas, HATSCHEK, Thomas, FOUKAKIS, Theodoros, JOHANSSON, Hemming, HELLSTRÖM, Mats, AGARTZ, Susanne, GRYBÄCK, Per, SALGKAMIS, Dimitrios, ZERDES, Ioannis, WANG, Kang, HARTMAN, Johan, ACS, Balazs, SUN, Wenwen, MATIKAS, Alexios, TZORAS, Evangelos, SARAFIDIS, Michail, SIFAKIS, Emmanouil g., BJÖHLE, Judith, BARNEKOW, Elin, MARGOLIN, Sara, ISAKSSON FRIMAN, Erika, EDMAN KESSLER, Luisa, ZOUZOS, Athanasios, BOYACI, Ceren, VILLACAMPA, Guillermo. Neoadjuvant palbociclib and endocrine therapy versus chemotherapy in ER + /HER2- breast cancer: a randomized phase II trial. _Nature Communications_. 2026. Vol. 17, núm. 3403. [consulta: 5 de maig de 2026]. ISSN: 2041-1723. [Disponible a: https://hdl.handle.net/2445/229249]

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