Evidence map›Paper›PMID 41188218›Full record

Trial reportNature communications2025

HER2DX in older patients with HER2-positive early breast cancer: extended follow-up from the RESPECT trial of trastuzumab ± chemotherapy.

Kazuki Nozawa, Masataka Sawaki, Yukari Uemura, Michiko Tsuneizumi, Toshimi Takano, Naomi Gondo, Fumikata Hara, Michiko Harao, Tatsuya Toyama, Naruto Taira and 12 more

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Nature communications, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01104935 (Evaluation of Trastuzumab Without Chemotherapy as a Postoperative Adjuvant Therapy in HER2 Positive Elderly Breast Cancer Patients), 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.

NCT01104935 phase3completednot on this map

Evaluation of Trastuzumab Without Chemotherapy as a Postoperative Adjuvant Therapy in HER2 Positive Elderly Breast Cancer Patients: Randomized Controlled Trial

TypeinterventionalSponsorComprehensive Support Project for Oncology ResearchRan2009 to 2018Enrolled275ConditionsBreast CancerArmstrastuzumab monotherapy, trastuzumab and chemotherapy
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

22 authors.

Kazuki NozawaDepartment of Advanced Clinical Research and Development, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
Masataka SawakiDepartment of Breast Oncology, Nagoya Medical Center, Nagoya, Japan.
Yukari UemuraBiostatistics Section, Department of Data Science, Center of Clinical Sciences, National Center for Global Health and Medicine, Shinjuku, Japan.
Michiko TsuneizumiDepartment of Breast Surgery, Shizuoka General Hospital, Shizuoka, Japan.
Toshimi TakanoDepartment of Breast Medical Oncology, The Cancer Institute Hospital of JFCR, Koto, Japan.ORCID http://orcid.org/0000-0002-8417-5291
Naomi GondoDepartment of Breast and Thyroid Surgical Oncology, Sagara Hospital, Kagoshima, Japan.
Fumikata HaraDepartment of Breast Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Michiko HaraoDepartment of Breast Oncology, Jichi Medical University, Shimotsuke, Japan.
Tatsuya ToyamaDepartment of Breast Surgery, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.ORCID http://orcid.org/0000-0003-4713-7795
Naruto TairaDepartment of Breast and Thyroid Surgery, Kawasaki Medical School, Kurashiki, Japan.
Ana VivancosReveal Genomics, Barcelona, Spain.ORCID http://orcid.org/0000-0003-2888-6512
Charles M PerouDepartment of Genetics, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA.
Esther SanfeliuReveal Genomics, Barcelona, Spain.
Fara Brasó-MaristanyReveal Genomics, Barcelona, Spain.
Joel S ParkerReveal Genomics, Barcelona, Spain.
Wesley BuckinghamReveal Genomics, Barcelona, Spain.ORCID http://orcid.org/0009-0006-4707-9803
Laia ParéReveal Genomics, Barcelona, Spain.
Guillermo VillacampaStatistics Unit, Vall d'Hebron Institute of Oncology, Barcelona, Spain.
Mercedes Marín-AguileraReveal Genomics, Barcelona, Spain.
Patricia VillagrasaReveal Genomics, Barcelona, Spain.
Aleix PratReveal Genomics, Barcelona, Spain. alprat@clinic.cat.ORCID http://orcid.org/0000-0003-2377-540X
Hiroji IwataDepartment of Advanced Clinical Research and Development, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Older adults with HER2-positive early breast cancer are underrepresented in clinical trials, and the benefit of chemotherapy in this population remains uncertain. We evaluated the HER2DX genomic assay within the randomized RESPECT trial (NCT01104935), which compared adjuvant trastuzumab with or without chemotherapy in patients aged 70-80 years. In this prespecified translational analysis (Trans-RESPECT), HER2DX scores were available for 154 patients. The HER2DX risk score classified 74.0% as low risk and 26.0% as high risk. Ten-year relapse-free and overall survival were higher in the low-risk group. HER2DX remained independently associated with overall survival in multivariable analysis. The HER2DX immune, luminal, and proliferation signatures that compose the risk score were also prognostic. While the HER2DX pCR score was not prognostic overall, exploratory subgroup analyses suggested a potential survival benefit from chemotherapy in the pCR-high group. HER2DX offers prognostic value and may guide chemotherapy use in older patients with HER2-positive early breast cancer. Clinical Trial Information NCT01104935.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsErb-b2 Receptor Tyrosine KinasesTrastuzumabAgedAged, 80 and overBiomarkers, TumorChemotherapy, AdjuvantFemaleFollow-Up StudiesHumansPrognosisBiomarkers, TumorERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesTrastuzumab

Identifiers

PMID41188218
PMCPMC12586486

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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.