Evidence map›Paper›PMID 40514709›Full record

ArticleBreast cancer research : BCR2025

Association of HER2-low with clinicopathological features in patients with early invasive lobular breast cancer: an international multicentric study.

Karen Van Baelen, Ha-Linh Nguyen, François Richard, Gitte Zels, Maria Margarete Karsten, Guilherme Nader-Marta, Peter Vermeulen, Luc Dirix, Adam David Dordevic, Evandro de Azambuja and 9 more

Registry-linked trialAbstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Breast cancer research : BCR, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07613151 (NAPOLI), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT07613151 recruitingnot on this mapstarted 2026, after this paper: background citation

NAPOLI: Negative/Low Hormone Receptor and APOcrine Lobular Invasive Breast Carcinoma - A Real-World International Cohort Study

TypeobservationalSponsorIstituto Oncologico Veneto IRCCSRan2026 to 2027Enrolled250ConditionsLobular Breast CarcinomaArmsUpfront Breast Surgery, Adjuvant Radiotherapy, Endocrine Therapy, Chemotherapy
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Toward targeted therapeutics for lobular breast cancer.The Journal of clinical investigation · 2026
    Review
  2. Article
  3. 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

19 authors.

Karen Van Baelen *Department of Oncology, Laboratory for Translational Breast Cancer Research (LTBCR), KU Leuven, Box 810, Herestraat 49, O&N IV, Louvain, 3000, Belgium.ORCID http://orcid.org/0000-0002-5700-3574
Ha-Linh Nguyen *Department of Oncology, Laboratory for Translational Breast Cancer Research (LTBCR), KU Leuven, Box 810, Herestraat 49, O&N IV, Louvain, 3000, Belgium.ORCID http://orcid.org/0000-0002-2538-7657
François RichardDepartment of Oncology, Laboratory for Translational Breast Cancer Research (LTBCR), KU Leuven, Box 810, Herestraat 49, O&N IV, Louvain, 3000, Belgium.ORCID http://orcid.org/0000-0003-4353-3619
Gitte ZelsDepartment of Oncology, Laboratory for Translational Breast Cancer Research (LTBCR), KU Leuven, Box 810, Herestraat 49, O&N IV, Louvain, 3000, Belgium.ORCID http://orcid.org/0000-0002-6332-3830
Maria Margarete KarstenDepartment of Gynecology and Breast Center, Charité Universitätsmedizin Berlin, Berlin, Germany.ORCID http://orcid.org/0000-0001-7587-7550
Guilherme Nader-MartaInstitut Jules Bordet, l'Université Libre de Bruxelles (ULB), Hôpital Universitaire de Bruxelles (H.U.B), Brussels, Belgium.ORCID http://orcid.org/0000-0001-7864-3637
Peter VermeulenDepartment of Oncology, Laboratory for Translational Breast Cancer Research (LTBCR), KU Leuven, Box 810, Herestraat 49, O&N IV, Louvain, 3000, Belgium.ORCID http://orcid.org/0000-0002-5676-3141
Luc DirixTranslational Cancer Research Unit, Oncology Centre Antwerp, Ziekenhuis Aan de Stroom, Antwerp, Belgium.ORCID http://orcid.org/0000-0002-6248-1677
Adam David DordevicDepartment of Gynecology and Breast Center, Charité Universitätsmedizin Berlin, Berlin, Germany.
Evandro de AzambujaInstitut Jules Bordet, l'Université Libre de Bruxelles (ULB), Hôpital Universitaire de Bruxelles (H.U.B), Brussels, Belgium.ORCID http://orcid.org/0000-0001-9501-4509
Denis LarsimontInstitut Jules Bordet, l'Université Libre de Bruxelles (ULB), Hôpital Universitaire de Bruxelles (H.U.B), Brussels, Belgium.
Marion MaetensDepartment of Oncology, Laboratory for Translational Breast Cancer Research (LTBCR), KU Leuven, Box 810, Herestraat 49, O&N IV, Louvain, 3000, Belgium.ORCID http://orcid.org/0000-0002-0505-2622
Elia BiganzoliDepartment of Clinical Sciences and Community Health & DSRC, Unit of Medical Statistics, Biometry and Epidemiology "Giulio A. Maccacaro", University of Milan, Milan, Italy.ORCID http://orcid.org/0000-0003-1202-5873
Hans WildiersDepartment of General Medical Oncology, University Hospitals Leuven, Louvain, Belgium.ORCID http://orcid.org/0000-0001-8990-7837
Ann SmeetsDepartment of Surgical Oncology, University Hospitals Leuven, Louvain, Belgium.ORCID http://orcid.org/0000-0002-5091-6602
Ines NevelsteenDepartment of Surgical Oncology, University Hospitals Leuven, Louvain, Belgium.ORCID http://orcid.org/0000-0003-4380-7413
Patrick NevenDepartment of Gynecological Oncology, University Hospitals Leuven, Louvain, Belgium.ORCID http://orcid.org/0000-0002-1434-9460
Giuseppe FlorisDepartment of Pathology, University Hospitals Leuven, Louvain, Belgium.ORCID http://orcid.org/0000-0003-2391-5425
Christine DesmedtDepartment of Oncology, Laboratory for Translational Breast Cancer Research (LTBCR), KU Leuven, Box 810, Herestraat 49, O&N IV, Louvain, 3000, Belgium. christine.desmedt@kuleuven.be.ORCID http://orcid.org/0000-0002-5223-5579

Funding

Research Foundation Flanders 1297322 N
6 · The paper itself

Abstract

purposeThe antibody-drug conjugate trastuzumab deruxtecan has proven to be not only efficient in patients with HER2+ breast cancers (BC), but also in those patients with so-called HER2-low BC. HER2-low tumors are well described in the general BC population, but not in patients with invasive lobular carcinoma (ILC). Here, we aimed at analyzing the association of HER2-low with clinicopathological features and survival outcomes in patients with early-stage pure ILC.

methodsA multicentric retrospective cohort of patients diagnosed with stage I-III estrogen receptor positive (ER+) HER2 negative (HER2-) ILC between 01/01/2000 and 12/31/2020 was assembled. HER2- disease was categorized further by immunohistochemical (IHC) score into HER2 0, HER2 1+ and HER2 2+ following time appropriate ASCO/CAP guidelines from 2007 onward and by local guidelines prior to 2007. The association of HER2-low (HER2 1+ and 2+) with clinicopathological variables was assessed using multinomial logistic regression. Survival analyses were performed to evaluate the association of HER2-low with disease-free (DFS), distant recurrence-free (DRFS) and overall survival (OS).

resultsThe data of 2098 patients with ER+ HER2- ILC was collected of which 1103 (52.6%) had a HER2-low tumor. Of these 716 (34.1%) had an IHC score of HER2 1+ and 387 (18.4%) of HER2 2+. In multivariable analysis, both tumor size of ≥ 2cm (OR: 1.37; 95%CI 1.01 - 1.87; p-value 0.042) and multifocality (OR: 1.55; 95%CI 1.11 - 2.15; p-value 0.009) were associated with HER2-low. HER2-low was associated with worse DFS (HR: 1.32; 95%CI 1.06 - 1.66; p-value 0.015) and OS (HR: 1.42; 95%CI 1.12 - 1.81; p-value 0.004) as compared to HER2 0. No association of HER2-low with DRFS was observed.

conclusionsHER2-low is present in more than half of the patients with early ER+ HER2- pure ILCs and is associated with larger tumor size and multifocality. HER2-low is associated with a worse DFS and OS as compared to HER2 0.

Indexed as

Biomarkers, TumorBreast NeoplasmsCarcinoma, LobularErb-b2 Receptor Tyrosine KinasesAdultAgedFemaleHumansMiddle AgedNeoplasm StagingPrognosisReceptors, EstrogenRetrospective StudiesBiomarkers, TumorERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesReceptors, EstrogenClinicopathological featuresHER2-lowInvasive lobular carcinomaSurvival

Identifiers

PMID40514709
PMCPMC12166569

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Registered trials

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