Evidence mapPaperPMID 41762297Full record

Observational studyBreast cancer research and treatment2026

Real-world second- and third-line progression-free survival after progression on first-line CDK4/6 inhibitors in HR+/HER2- metastatic breast cancer by PAM50 intrinsic subtype: the SOLTI-1801 CDK-PREDICT study.

Pablo Tolosa, Isabel García-Fructuoso, Tomás Pascual, Olga Martínez-Sáez, Juan Miguel Cejalvo, Sonia Servitja, María Fernández Abad, Javier David Benitez Fuentes, Fara Brasó-Maristany, Ester Sanfeliu and 16 more

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Breast cancer research and treatment, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

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4 · The record

Corrections and comments

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5 · Who and what money

Authors and funding

26 authors.

Pablo TolosaMedical Oncology Department, Hospital 12 de Octubre, Madrid, Spain. pablo.tolosa@salud.madrid.org.
Isabel García-FructuosoClínic Barcelona Comprehensive Cancer Center, Hospital Clínic de Barcelona, Barcelona, Spain.
Tomás PascualSOLTI Cancer Research Group, Barcelona, Spain.
Olga Martínez-SáezClínic Barcelona Comprehensive Cancer Center, Hospital Clínic de Barcelona, Barcelona, Spain.
Juan Miguel CejalvoSOLTI Cancer Research Group, Barcelona, Spain.
Sonia ServitjaHospital del Mar Research Institute (IMIM), Barcelona, Spain.
María Fernández AbadHospital Universitario Ramón y Cajal, Madrid, Spain.
Javier David Benitez FuentesOncology Department, Hospital Clínico San Carlos, Madrid, Spain.
Fara Brasó-MaristanyClínic Barcelona Comprehensive Cancer Center, Hospital Clínic de Barcelona, Barcelona, Spain.
Ester SanfeliuTranslational Genomics and Targeted Therapies in Solid Tumors, August Pi I Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain.
Laura LemaMedical Oncology Department, Hospital 12 de Octubre, Madrid, Spain.
Yolanda RuanoDepartment of Pathology, Molecular Pathology Unit, Hospital Universitario 12 de Octubre, Madrid, Spain.
Lucía ParrillaDepartment of Pathology, Hospital Universitario 12 de Octubre, Madrid, Spain.
Ana María RonceroMedical Oncology Department, Hospital 12 de Octubre, Madrid, Spain.
María Ángeles CobosMedical Oncology Department, Hospital 12 de Octubre, Madrid, Spain.
Irene DíazMedical Oncology Department, Hospital 12 de Octubre, Madrid, Spain.
Karla Alicia Centelles LópezUnidad de Tumores Mamarios, Instituto Nacional de Cancerología, Ciudad de Mexico, México.
Rodrigo Sánchez-BayonaMedical Oncology Department, Hospital 12 de Octubre, Madrid, Spain.
Manuel AlvaMedical Oncology Department, Hospital 12 de Octubre, Madrid, Spain.
Ainhoa MadariagaMedical Oncology Department, Hospital 12 de Octubre, Madrid, Spain.
Guillermo VillacampaSOLTI Cancer Research Group, Barcelona, Spain.
Fernando SalvadorSOLTI Cancer Research Group, Barcelona, Spain.
Agustín Sánchez-BelmonteVall d ́Hebron Institute of Oncology (VHIO), Barcelona, Spain.
Marcos MalumbresVall d ́Hebron Institute of Oncology (VHIO), Barcelona, Spain.
Aleix PratSOLTI Cancer Research Group, Barcelona, Spain.
Eva CiruelosMedical Oncology Department, Hospital 12 de Octubre, Madrid, Spain. eva.ciruelos@gmail.com.

Funding

Instituto de Salud Carlos III (ISCIII) DTS21/00111Instituto de Salud Carlos III (ISCIII) PI 18/01408"Proyectos Líneas Estratégicas Colaboración" funded by the Ministerio de Inovación y Ciencias and the "Unión Europea Next Generation" PLEC2021-007892the "Proyectos Líneas Estratégicas Colaboración" funded by the Ministerio de Inovación y Ciencias and the "Unión Europea Next Generation" PLEC2021-007892
6 · The paper itself

Abstract

purposeEstrogen receptor-positive (ER+), HER2-negative (HER2-) metastatic breast cancer (MBC) shows variable outcomes after first-line CDK4/6 inhibitors (CDK4/6i) plus endocrine therapy (ET). The prognostic role of PAM50 intrinsic subtypes (IS) in this setting remains unestablished. We evaluated IS and biomarker profiles in the SOLTI-1801 CDK-PREDICT cohort, focusing on real-world second- and third-line progression-free survival (rwPFS-2L and rwPFS-3L).

methodsThis multicenter observational study reports a post hoc secondary analysis of ER+ /HER2- MBC patients previously treated with first-line CDK4/6i plus ET. Baseline metastatic biopsies were molecularly profiled (PAM50, CCNE1, PDCD1) using the nCounter platform. rwPFS-2L and rwPFS-3L were defined from initiation of second- or third-line therapy to progression or death. Kaplan-Meier and Cox models assessed associations with clinical, molecular, and treatment variables.

resultsAmong evaluable patients (n = 125 for rwPFS-2L; n = 95 for rwPFS-3L), Luminal A/B subtypes represented most cases, while advanced lines showed more aggressive profiles. Median rwPFS-2L was 7.2 months in luminal IS vs. 6.1 in non-luminal (HR 1.40; 95% CI 0.86-2.30); the Basal-like (BL) subtype correlated with significantly shorter rwPFS-2L (HR 3.82; 95% CI 1.07-13.63). In rwPFS-3L, similar trends were seen (6.4 vs. 3.3 months; HR 1.74; 95% CI 0.98-3.08), with BL showing the poorest outcomes (HR 5.63; 95% CI 1.17-27.02). High CCNE1 expression was linked to shorter rwPFS-2L (HR 1.22; 95% CI 1.02-1.47). Targeted agents were frequent in 2L (51%) and capecitabine in 3L (36%), while endocrine monotherapy yielded poorest rwPFS.

conclusionsOutcomes after CDK4/6i progression differ by PAM50 IS, supporting its role in guiding post-progression treatment.

Indexed as

Breast NeoplasmsCyclin-Dependent Kinase 4Cyclin-Dependent Kinase 6Erb-b2 Receptor Tyrosine KinasesProtein Kinase InhibitorsAdultAgedBiomarkers, TumorFemaleHumansMiddle AgedNeoplasm MetastasisPrognosisProgression-Free SurvivalReceptors, EstrogenReceptors, ProgesteroneBiomarkers, TumorCDK4 protein, humanCDK6 protein, humanCyclin-Dependent Kinase 4Cyclin-Dependent Kinase 6ERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesProtein Kinase InhibitorsReceptors, EstrogenReceptors, ProgesteroneCDK 4/6 inhibitorsHormone receptor-positive/HER2-negative advanced breast cancerIntrinsic subtypesPAM50PI3K inhibitorsrwPFS-2LSERDs

Identifiers

PMID41762297
PMCPMC12950024

What Socratic holds

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LicenceCC BY-NC-ND
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.