Evidence map›Paper›PMID 37302750›Full record

ArticleAnnals of oncology : official journal of the European Society for Medical Oncology2023

Association of HER2DX with pathological complete response and survival outcomes in HER2-positive breast cancer.

G Villacampa, N M Tung, S Pernas, L Paré, C Bueno-Muiño, I Echavarría, S López-Tarruella, M Roche-Molina, M Del Monte-Millán, M Marín-Aguilera and 25 more

Registry-linked trialAbstract read
In one paragraph

Article in Annals of oncology : official journal of the European Society for Medical Oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07220135 (A Randomized Trial of Neoadjuvant THP vs TCHP for HER2-amplified/Positive Breast Cancer), which is not on this map. Cited by 44 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 1 pooled it
–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.

NCT07220135 phase2recruitingnot on this mapstarted 2025, after this paper: background citation

A Randomized Trial of Neoadjuvant THP vs TCHP for HER2-amplified/Positive Breast Cancer (NeoTHERa)

TypeinterventionalSponsorUniversity of Kansas Medical CenterRan2025 to 2031Enrolled100ConditionsBreast CancerArmsCarboplatin, Docetaxel, Trastuzumab (or biosimilar), Pertuzumab (or biosimilar)
3 · Its place in the literature

Who cites it

44 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  14. Associations of the HER2DX Genomic Test with Biological and Pathologic Features in HER2-Positive Breast Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Article
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  19. CD8Signal transduction and targeted therapy · 2025
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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

35 authors.

G VillacampaSOLTI Breast Cancer Research Group, Barcelona; Oncology Data Science, Vall d'Hebron Institute of Oncology, Barcelona, Spain.
N M TungBeth Israel, Boston, USA.
S PernasMedical Oncology Department, Catalan Institute of Oncology, L'Hospitalet de Llobregat, Barcelona.
L ParéReveal Genomics, Barcelona.
C Bueno-MuiñoMedical Oncology Department, Hospital Infanta Cristina (Parla), Fundación de Investigación Biomédica del H.U. Puerta de Hierro, Majadahonda, Madrid.
I EchavarríaDepartment of Medical Oncology, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, CiberOnc, Madrid.
S López-TarruellaDepartment of Medical Oncology, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, CiberOnc, Madrid.
M Roche-MolinaDepartment of Medical Oncology, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, CiberOnc, Madrid.
M Del Monte-MillánDepartment of Medical Oncology, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, CiberOnc, Madrid.
M Marín-AguileraReveal Genomics, Barcelona.
F Brasó-MaristanyTranslational Genomics and Targeted Therapies in Solid Tumors, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona; Department of Medical Oncology, Hospital Clinic of Barcelona, Barcelona, Spain.
A G WaksMedical Oncology, Dana-Farber Cancer Institute, Boston; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston; Harvard Medical School, Boston, USA.
T PascualSOLTI Breast Cancer Research Group, Barcelona; Translational Genomics and Targeted Therapies in Solid Tumors, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona; Department of Medical Oncology, Hospital Clinic of Barcelona, Barcelona, Spain.
O Martínez-SáezTranslational Genomics and Targeted Therapies in Solid Tumors, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona; Department of Medical Oncology, Hospital Clinic of Barcelona, Barcelona, Spain.
A VivancosCancer Genomics Group, VHIO, Barcelona, Spain.
P F ConteDepartment of Surgery, Oncology and Gastroenterology, University of Padova, Padova; Istituto Oncologico Veneto, IRCCS, Padova, Italy.
V GuarneriDepartment of Surgery, Oncology and Gastroenterology, University of Padova, Padova; Istituto Oncologico Veneto, IRCCS, Padova, Italy.
M Vittoria DieciDepartment of Surgery, Oncology and Gastroenterology, University of Padova, Padova; Istituto Oncologico Veneto, IRCCS, Padova, Italy.
G GriguoloDepartment of Surgery, Oncology and Gastroenterology, University of Padova, Padova; Istituto Oncologico Veneto, IRCCS, Padova, Italy.
J CortésInternational Breast Cancer Center, Pangaea Oncology, Quirónsalud Group, Barcelona.
A Llombart-CussacArnau de Vilanova Hospital, Universidad Católica de Valencia, Valencia, Spain.
M MuñozTranslational Genomics and Targeted Therapies in Solid Tumors, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona; Department of Medical Oncology, Hospital Clinic of Barcelona, Barcelona, Spain.
M VidalTranslational Genomics and Targeted Therapies in Solid Tumors, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona; Department of Medical Oncology, Hospital Clinic of Barcelona, Barcelona, Spain.
B AdamoTranslational Genomics and Targeted Therapies in Solid Tumors, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona; Department of Medical Oncology, Hospital Clinic of Barcelona, Barcelona, Spain.
A C WolffDepartment of Oncology, Johns Hopkins University School of Medicine, Baltimore.
A DeMicheleDepartment of Oncology, University of Pennsylvania, Philadelphia.
P VillagrasaReveal Genomics, Barcelona.
J S ParkerLineberger Comprehensive Cancer Center, Department of Genetics, University of North Carolina at Chapel Hill, Chapel Hill.
C M PerouLineberger Comprehensive Cancer Center, Department of Genetics, University of North Carolina at Chapel Hill, Chapel Hill.
A Fernandez-MartinezLineberger Comprehensive Cancer Center, Department of Genetics, University of North Carolina at Chapel Hill, Chapel Hill.
L A CareyLineberger Comprehensive Cancer Center, Department of Genetics, University of North Carolina at Chapel Hill, Chapel Hill.
E A MittendorfMedical Oncology, Dana-Farber Cancer Institute, Boston; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston; Harvard Medical School, Boston, USA; Division of Breast Surgery, Department of Surgery, Brigham and Women's Hospital, Boston, USA.
M MartínDepartment of Medical Oncology, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, CiberOnc, Madrid.
A PratReveal Genomics, Barcelona; Translational Genomics and Targeted Therapies in Solid Tumors, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona; Department of Medical Oncology, Hospital Clinic of Barcelona, Barcelona, Spain; Institute of Oncology (IOB)-Quirón, Barcelona, Spain. Electronic address: alprat@clinic.cat.
S M TolaneyMedical Oncology, Dana-Farber Cancer Institute, Boston; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston; Institute of Oncology (IOB)-Quirón, Barcelona, Spain. Electronic address: sara_tolaney@dfci.harvard.edu.

Funding

UNC Lead Academic Participating SiteUG1CA233373 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI CAREY, LISA A, DEES, ELIZABETH CLAIRE · 2019 to 2025
$3.5M
NCI NIH HHS UG1 CA233373
6 · The paper itself

Abstract

backgroundThe HER2DX genomic test predicts pathological complete response (pCR) and survival outcome in early-stage HER2-positive (HER2+) breast cancer. Here, we evaluated the association of HER2DX scores with (i) pCR according to hormone receptor status and various treatment regimens, and (ii) survival outcome according to pCR status. MATERIALS AND

methodsSeven neoadjuvant cohorts with HER2DX and clinical individual patient data were evaluated (DAPHNe, GOM-HGUGM-2018-05, CALGB-40601, ISPY-2, BiOnHER, NEOHER and PAMELA). All patients were treated with neoadjuvant trastuzumab (n = 765) in combination with pertuzumab (n = 328), lapatinib (n = 187) or without a second anti-HER2 drug (n = 250). Event-free survival (EFS) and overall survival (OS) outcomes were available in a combined series of 268 patients (i.e. NEOHER and PAMELA) with a pCR (n = 118) and without a pCR (n = 150). Cox models were adjusted to evaluate whether HER2DX can identify patients with low or high risk beyond pCR status.

resultsHER2DX pCR score was significantly associated with pCR in all patients [odds ratio (OR) per 10-unit increase = 1.59, 95% confidence interval 1.43-1.77; area under the ROC curve = 0.75], with or without dual HER2 blockade. A statistically significant increase in pCR rate due to dual HER2 blockade over trastuzumab-only was observed in HER2DX pCR-high tumors treated with chemotherapy (OR = 2.36 (1.09-5.42). A statistically significant increase in pCR rate due to multi-agent chemotherapy over a single taxane was observed in HER2DX pCR-medium tumors treated with dual HER2 blockade (OR = 3.11, 1.54-6.49). The pCR rates in HER2DX pCR-low tumors were ≤30.0% regardless of treatment administered. After adjusting by pCR status, patients identified as HER2DX low-risk had better EFS (P < 0.001) and OS (P = 0.006) compared with patients with HER2DX high-risk.

conclusionsHER2DX pCR score and risk score might help identify ideal candidates to receive neoadjuvant dual HER2 blockade in combination with a single taxane in early-stage HER2+ breast cancer.

Indexed as

Breast NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsBridged-Ring CompoundsErb-b2 Receptor Tyrosine KinasesFemaleHumansNeoadjuvant TherapyTaxoidsTrastuzumabTreatment OutcomeBridged-Ring CompoundsErb-b2 Receptor Tyrosine KinasestaxaneTaxoidsTrastuzumabbreast cancerHER2HER2DXneoadjuvantpathological complete responsepertuzumab

Identifiers

PMID37302750
PMCPMC10735273

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Registered trials

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