Evidence map›Paper›PMID 39854658›Full record

Trial reportJCO precision oncology2025

Genomic Characterization and Prognostic Significance of Human Epidermal Growth Factor Receptor 2-Low, Hormone Receptor-Positive, Early Breast Cancers From the BIG 1-98 and SOFT Clinical Trials.

Stephen J Luen, Lauren C Brown, Courtney T van Geelen, Peter Savas, Roswitha Kammler, Patrizia Dell'Orto, Olivia Biasi, Alan S Coates, Richard D Gelber, Beat Thürlimann and 6 more

Abstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in JCO precision oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
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

16 authors.

Stephen J LuenDepartment of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
Lauren C BrownDepartment of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
Courtney T van GeelenSir Peter MacCallum Department of Oncology, The University of Melbourne, Victoria, Australia.ORCID 0000-0002-2716-9135
Peter SavasDepartment of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.ORCID 0000-0001-5999-428X
Roswitha KammlerInternational Breast Cancer Study Group, Coordinating Center, Central Pathology Office, Bern, Switzerland.ORCID 0000-0002-5572-7894
Patrizia Dell'OrtoInternational Breast Cancer Study Group Central Pathology Office, Milan, Italy.ORCID 0000-0001-9166-0829
Olivia BiasiInternational Breast Cancer Study Group Central Pathology Office, Milan, Italy.
Alan S CoatesInternational Breast Cancer Study Group and University of Sydney, Sydney, Australia.ORCID 0000-0002-0141-7356
Richard D GelberDepartment of Data Science, Dana-Farber Cancer Institute, Harvard Medical School, Harvard T.H. Chan School of Public Health, and Frontier Science and Technology Research Foundation, Boston, MA.ORCID 0000-0001-8270-8712
Beat ThürlimannSwissBreastCare, Zürich, Switzerland.
Marco ColleoniDivision of Medical Senology, IEO, European Institute of Oncology IRCCS, Milan, Italy.ORCID 0000-0002-5743-3013
Gini F FlemingDepartment of Medicine, The University of Chicago, Chicago, IL.ORCID 0000-0003-2845-4023
Prudence A FrancisDepartment of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.ORCID 0000-0002-7207-9286
Meredith M ReganDivision of Biostatistics, International Breast Cancer Study Group Statistical Center, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA.ORCID 0000-0002-2428-6109
Giuseppe VialeInternational Breast Cancer Study Group Central Pathology Office, Milan, Italy.ORCID 0000-0003-1882-7068
Sherene LoiDepartment of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.ORCID 0000-0001-6137-9171

Funding

Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
NCIC Clinical Trials Group - Canadian Collaborating Clinical Trials NetworkU10CA180863 · NCI · QUEEN'S UNIVERSITY AT KINGSTON · PI Janet Ellen Dancey · 2014 to 2026
$40.4M
IBCSG STATISTICAL CENTER--A BREAST CANCER STUDY RESOURCEU24CA075362 · NCI · DANA-FARBER CANCER INSTITUTE · PI REGAN, MEREDITH M · 1997 to 2015
$7.5M
NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180863NCI NIH HHS U24 CA075362
6 · The paper itself

Abstract

purposeTo investigate whether hormone receptor-positive, human epidermal growth factor receptor 2-low (HR+HER2-low) versus HR+HER2-zero early breast cancers have distinct genomic and clinical characteristics.

methodsThis study included HR+, HER2-negative early breast cancers from patients enrolled in the phase III, randomized BIG 1-98 and SOFT clinical trials that had undergone tumor genomic sequencing. Tumors were classified HR+HER2-low if they had a centrally reviewed HER2 immunohistochemistry (IHC) score of 1+ or 2+ with negative in situ hybridization and HR+HER2-zero if they had an HER2 IHC score of 0.

resultsA total of 1,795 tumors were evaluable for this study (BIG 1-98 n = 520, SOFT n = 1,275). The frequency of HER2-low tumors was 37% and 21% in the postmenopausal BIG 1-98 and premenopausal SOFT cohorts, respectively. There were no significant differences in clinicopathologic variables between HER2-low and HER2-zero groups which was consistent across both trials. There was no significant difference in risk of distant recurrence for patients with HER2-low tumors versus HER2-zero tumors (5-year % distant recurrence-free 94.0%

conclusionIn two large clinical trials with centrally reviewed HER2 IHC, our findings do not support HER2-low breast cancer as a distinct clinical or biologic entity among HR+HER2- early breast cancers. Absolute differences in median

Indexed as

Breast NeoplasmsErb-b2 Receptor Tyrosine KinasesReceptors, EstrogenReceptors, ProgesteroneAdultAgedFemaleGenomicsHumansMiddle AgedPrognosisERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesReceptors, EstrogenReceptors, Progesterone

Identifiers

PMID39854658
PMCPMC11835511

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Registered trials

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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.