Evidence map›Paper›PMID 41569440›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2026

Pembrolizumab and Paclitaxel in Patients with HR+/HER2- Breast Cancer with HER2-Enriched or Basal-like Subtypes.

Benedetta Conte, Fara Brasó-Maristany, Tomás Pascual, Cristina Hernando, Silvia Vázquez, Salvador Blanch, Mafalda Oliveira, Juan Antonio Virizuela, Montserrat Muñoz, Elia Seguí and 16 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04251169 (Targeting Non-Luminal Disease by PAM50 With Pembrolizumab + Paclitaxel in Hormone Receptor-positive/HER2-negative Advanced/Metastatic Breast Cancer, Who Have Progressed on or After CDK 4/6 Inhibitor Treatment), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

NCT04251169 phase2terminatednot on this map

Targeting Non-Luminal Disease by PAM50 With Pembrolizumab + Paclitaxel in Hormone Receptor-positive/HER2-negative Advanced/Metastatic Breast Cancer, Who Have Progressed on or After CDK 4/6 Inhibitor Treatment

TypeinterventionalSponsorSOLTI Breast Cancer Research GroupRan2020 to 2024Enrolled20ConditionsMetastatic Breast CancerArmsPembrolizumab, Paclitaxel
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

26 authors.

Benedetta ConteFacultat de Medicina i Ciències de la Salut, Universitat de Barcelona (UB) , Barcelona, Spain.ORCID 0000-0003-4720-2497
Fara Brasó-MaristanyTranslational Genomics and Targeted Therapies in Solid Tumors, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain.ORCID 0000-0001-5440-9643
Tomás PascualFacultat de Medicina i Ciències de la Salut, Universitat de Barcelona (UB) , Barcelona, Spain.ORCID 0000-0001-8431-3183
Cristina HernandoBiomedical Research Institute INCLIVA, Valencia, Spain.ORCID 0000-0002-6865-4196
Silvia VázquezSOLTI Cancer Research Group , Barcelona, Spain.ORCID 0000-0002-0287-6191
Salvador BlanchSOLTI Cancer Research Group , Barcelona, Spain.ORCID 0009-0008-9553-2179
Mafalda OliveiraSOLTI Cancer Research Group , Barcelona, Spain.ORCID 0000-0001-9152-8799
Juan Antonio VirizuelaSOLTI Cancer Research Group , Barcelona, Spain.ORCID 0009-0005-7337-8615
Montserrat MuñozDepartment of Translational Medicine, University of Piemonte Orientale, Novara, Italy.ORCID 0000-0001-7772-1437
Elia SeguíFacultat de Medicina i Ciències de la Salut, Universitat de Barcelona (UB) , Barcelona, Spain.ORCID 0000-0001-7770-9825
Adela Rodriguez-HernandezFacultat de Medicina i Ciències de la Salut, Universitat de Barcelona (UB) , Barcelona, Spain.ORCID 0000-0002-4899-6607
Maria Jesus Vidal LosadaFacultat de Medicina i Ciències de la Salut, Universitat de Barcelona (UB) , Barcelona, Spain.ORCID 0000-0003-1992-5727
Patricia GalvánTranslational Genomics and Targeted Therapies in Solid Tumors, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain.ORCID 0000-0002-8153-0307
Oleguer CastilloTranslational Genomics and Targeted Therapies in Solid Tumors, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain.ORCID 0000-0003-0260-8127
Paula BlascoTranslational Genomics and Targeted Therapies in Solid Tumors, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain.ORCID 0000-0002-8858-210X
Manuel AlvaMedical Oncology Department, University of Piemonte Orientale, Madrid, Spain.ORCID 0000-0002-2016-4972
Nuria ChicTranslational Genomics and Targeted Therapies in Solid Tumors, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain.ORCID 0000-0001-9736-6276
Esther SanfeliuTranslational Genomics and Targeted Therapies in Solid Tumors, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain.ORCID 0000-0002-7974-3346
Sara Cano-CrespoSOLTI Cancer Research Group , Barcelona, Spain.ORCID 0009-0006-4615-5640
Fernando SalvadorSOLTI Cancer Research Group , Barcelona, Spain.ORCID 0000-0002-5442-1754
Guillermo VillacampaStatistics Unit, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.ORCID 0000-0003-4868-6585
Lorea VillanuevaSOLTI Cancer Research Group , Barcelona, Spain.ORCID 0000-0003-1858-7076
Juan Manuel Ferrero-CafieroSOLTI Cancer Research Group , Barcelona, Spain.ORCID 0000-0001-8796-8812
Ana VivancosGenomics Cancer Group, Vall d'Hebron Institute of Oncology, Barcelona, Spain.ORCID 0000-0003-2888-6512
Aleix PratFacultat de Medicina i Ciències de la Salut, Universitat de Barcelona (UB) , Barcelona, Spain.ORCID 0000-0003-2377-540X
Eva CiruelosSOLTI Cancer Research Group , Barcelona, Spain.ORCID 0000-0002-2796-1042

Funding

Breast Cancer Research Foundation (BCRF) BCRF-22-198Breast Cancer Research Foundation (BCRF) BCRF-23-198Breast Cancer Research Foundation (BCRF) BCRF-24-198CRIS Cancer Foundation (CRIS Foundation) PR_EX_2021-14Fundación Científica Asociación Española Contra el Cáncer (AECC) EPAEC246711CLINFundación Científica Asociación Española Contra el Cáncer (AECC) INVES21943BRASFundación Fero (Fundació Fero) ONCOXXI21Horizon 2020 Framework Programme (H2020) 847912HORIZON EUROPE Marie Sklodowska-Curie Actions (MSCA) 955951Instituto de Salud Carlos III (ISCIII) PI22/01017
6 · The paper itself

Abstract

purposeHormone receptor-positive (HR+), HER2-negative (HER2-) metastatic breast cancer (mBC) is biologically distinct from early-stage disease, with a higher prevalence of genomically defined nonluminal subtypes, particularly the HER2-enriched (HER2-E) and basal-like subtypes. These tumors are highly proliferative, less dependent on hormone signaling, and associated with poor outcomes and early resistance to endocrine therapy and CDK4/6 inhibition (CDK4/6i). This biological shift highlights the need for biomarker-driven strategies in the CDK4/6i-resistant setting. PATIENTS AND

methodsThe SOLTI-1716 TATEN trial (NCT04251169) is a phase II, single-arm study evaluating the combination of pembrolizumab and paclitaxel in patients with HR+/HER2- mBC classified as HER2-E or basal-like by PAM50 following progression on CDK4/6i. A total of 126 patients were screened using the PAM50 genomic assay; 20 with HER2-E or basal-like subtypes were enrolled and received pembrolizumab (200 mg every 3 weeks) and paclitaxel (80 mg/m2 weekly).

resultsThe primary endpoint, overall response rate (ORR), was 61.1% [95% confidence interval (CI), 35.7-82.7], and the clinical benefit rate was 94.4% (95% CI, 72.7-99.9). The median progression-free survival was 8.1 months (95% CI, 5.9-10.4), and the median overall survival was 26 months [95% CI, 18-not reached (NR)]. Three patients achieved durable responses lasting ≥24 months. Gene expression analyses revealed that high expression of proliferation- and immune-related genes predicted improved ORR and survival, whereas luminal-related gene expression was associated with lower clinical benefit.

conclusionsThese results suggest that chemo-immunotherapy may be an effective strategy in genomically defined nonluminal subtypes of HR+/HER2- mBC following CDK4/6i resistance and highlight the value of molecular subtyping to guide post-endocrine treatment decisions.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsErb-b2 Receptor Tyrosine KinasesAdultAgedAntibodies, Monoclonal, HumanizedBiomarkers, TumorFemaleHumansMiddle AgedPaclitaxelReceptors, EstrogenReceptors, ProgesteroneAntibodies, Monoclonal, HumanizedBiomarkers, TumorERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesPaclitaxelpembrolizumabReceptors, EstrogenReceptors, Progesterone

Identifiers

PMID41569440
PMCPMC13040208

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Registered trials

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 OpenQuestion graph.