Evidence map›Paper›PMID 39826476›Full record

Trial reportESMO open2025

HER2DX in HER2-positive inflammatory breast cancer: correlative insights and comparative analysis with noninflammatory breast cancers.

F Lynce, O Martínez-Sáez, B Walbaum, F Brasó-Maristany, A G Waks, P Villagrasa, G Villacampa Javierre, E Sanfeliu, P Galván, L Paré and 13 more

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

Trial report in ESMO open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01796197 (Phase II Trial of Paclitaxel Combined With Trastuzumab and Pertuzumab as Pre-Operative Therapy for Inflammatory Breast Cancer), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT01796197 phase2completednot on this map

Phase II Trial of Paclitaxel Combined With Trastuzumab and Pertuzumab as Pre-Operative Therapy for Inflammatory Breast Cancer

TypeinterventionalSponsorDana-Farber Cancer InstituteRan2013 to 2026Enrolled23ConditionsBreast CancerArmsTrastuzumab, Pertuzumab, Paclitaxel, Doxorubicin, Cyclophosphamide
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. 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
  2. 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

23 authors.

F LynceDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, USA; Harvard Medical School, Boston, USA. Electronic address: Filipa_Lynce@dfci.harvard.edu.
O Martínez-SáezMedical Oncology Department, Hospital Clinic, Barcelona, Spain; Department of Medicine, University of Barcelona, Barcelona, Spain; Translational Genomics and Targeted Therapies in Solid Tumors, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain.
B WalbaumMedical Oncology Department, Hospital Clinic, Barcelona, Spain; Department of Hematology-Oncology, School of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile.
F Brasó-MaristanyTranslational Genomics and Targeted Therapies in Solid Tumors, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain.
A G WaksDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, USA; Harvard Medical School, Boston, USA.
P VillagrasaReveal Genomics, Barcelona, Spain.
G Villacampa JavierreStatistics Unit, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain; Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, UK.
E SanfeliuPathology Department, Hospital Clinic, Barcelona, Spain.
P GalvánTranslational Genomics and Targeted Therapies in Solid Tumors, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain.
L ParéReveal Genomics, Barcelona, Spain.
L M AndersonDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, USA.
C M PerouLineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, USA.
J S ParkerLife Edit Therapeutics, Morrisville, USA.
A VivancosCancer Genomics Group, Vall d'Hebron Institute of Oncology (VHIO), Barcelona.
M K DiLulloDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, USA.
S PernasMedical Oncology Department, Catalan Institute of Oncology, L'Hospitalet, Barcelona, Spain.
E P WinerYale Cancer Center, New Haven, USA.
B OvermoyerDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, USA; Harvard Medical School, Boston, USA.
E A MittendorfDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, USA; Division of Breast Surgery, Department of Surgery, Brigham and Women's Hospital, Boston, USA.
C Bueno-MuiñoMedical Oncology Department, Hospital Infanta Cristina (Parla), Fundación de Investigación Biomédica H.U. Puerta de Hierro, Majadahonda, Madrid, Spain.
M MartínDepartment of Medical Oncology, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón, CIBERONC, Geicam, Universidad Complutense, Madrid, Spain.
A PratMedical Oncology Department, Hospital Clinic, Barcelona, Spain; Department of Medicine, University of Barcelona, Barcelona, Spain; Reveal Genomics, Barcelona, Spain; Institute of Oncology (IOB)-Hospital Quirónsalud, Barcelona, Spain.
S M TolaneyDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA; Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, USA; Harvard Medical School, Boston, USA.

Funding

Physician Scientist Training in Cancer ResearchT32CA009172 · NCI · DANA-FARBER CANCER INSTITUTE · PI Jennifer R Brown, James A. DeCaprio · 1985 to 2026
$17.1M
NCI NIH HHS T32 CA009172
6 · The paper itself

Abstract

backgroundThe HER2DX assay predicts long-term prognosis and pathologic complete response (pCR) in patients with early-stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer receiving neoadjuvant systemic therapy but has not been evaluated in inflammatory breast cancer (IBC). PATIENTS AND

methodsHER2DX was analyzed in baseline biopsy tissues from 23 patients with stage III HER2-positive IBC on a phase II trial (NCT01796197) treated with neoadjuvant trastuzumab, pertuzumab, and paclitaxel (THP). To assess the assay's predictive accuracy for pCR in IBC, clinical-pathological features and outcomes from this IBC cohort were compared with 156 patients with stage III HER2-positive non-IBC from four different cohorts. Comparative analyses included HER2DX scores, gene signatures, and expression of individual genes between patients with IBC and non-IBC.

resultsNotable differences in clinicopathological characteristics included higher pertuzumab and chemotherapy usage and lower axillary burden in patients with IBC compared with non-IBC. In the combined cohort (n = 179), HER2DX pCR score and pertuzumab use were significant predictors of pCR, but not IBC status. The pCR rates in patients treated with trastuzumab-based chemotherapy (including IBC and non-IBC) were 68.9%, 58.5%, and 16.3% in the HER2DX pCR-high, -medium, and -low groups, respectively. Comparative gene expression analysis indicated minor differences between IBC and non-IBC affecting individual HER2, immune, and proliferation genes.

conclusionsThe HER2DX pCR score could predict pCR in stage III HER2-positive IBC following treatment with de-escalated neoadjuvant systemic therapy and in stage III HER2-positive non-IBC. Elevated pCR rates in HER2-positive IBC with high HER2DX pCR scores suggest there may be a role for treatment de-escalation in these patients and confirmatory studies are justified.

Indexed as

Breast NeoplasmsErb-b2 Receptor Tyrosine KinasesInflammatory Breast NeoplasmsAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsFemaleHumansMiddle AgedNeoadjuvant TherapyPaclitaxelPrognosisTrastuzumabAntibodies, Monoclonal, HumanizedERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesPaclitaxelpertuzumabTrastuzumabHER2DXHER2-positiveinflammatory breast cancerpathologic complete response

Identifiers

PMID39826476
PMCPMC11786065

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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.