Evidence map›Paper›PMID 28302091›Full record

ArticleBMC cancer2017

Development of a test that measures real-time HER2 signaling function in live breast cancer cell lines and primary cells.

Yao Huang, David J Burns, Benjamin E Rich, Ian A MacNeil, Abhijit Dandapat, Sajjad M Soltani, Samantha Myhre, Brian F Sullivan, Carol A Lange, Leo T Furcht and 1 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in BMC cancer, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03812393 (Phase II Trial Evaluating the Efficacy and Safety of Neoadjuvant Neratinib and Chemotherapy in Early Stage Triple-Negative Breast Cancer Patients Who Exhibit Enhanced HER2 Signaling by Live Cell HER2 Signaling Transduction Analysis), which is not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
0.8field-weighted citation impact, top 26% of its field
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.

NCT03812393 phase2unknown statusnot on this mapstarted 2019, after this paper: background citation

Phase II Trial Evaluating the Efficacy and Safety of Neoadjuvant Neratinib and Chemotherapy in Early Stage Triple-Negative Breast Cancer Patients Who Exhibit Enhanced HER2 Signaling by Live Cell HER2 Signaling Transduction Analysis (FACT-2)

TypeinterventionalSponsorWest Cancer CenterRan2019 to 2024Enrolled27ConditionsTriple Negative Breast Cancer, Early-stage Breast Cancer, HER2-positive Breast CancerArmsNeratinib
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 17 citations in OpenAlex.

  1. Article
  2. Cancer-AssociatedInternational journal of medical sciences · 2025
    Review
  3. Article
  4. Article
  5. Review
  6. Article
  7. Review
  8. Article
  9. Cancer-associated mutations in the p85α N-terminal SH2 domain activate a spectrum of receptor tyrosine kinases.Proceedings of the National Academy of Sciences of the United States of America · 2021
    Article
  10. New HER2-negative breast cancer subtype responsive to anti-HER2 therapy identified.Journal of cancer research and clinical oncology · 2020
    Article
  11. Article
  12. Article
  13. 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

11 authors at 1 institution in 1 country.

Yao HuangCelcuity LLC, Minneapolis, MN, USA.
David J BurnsCelcuity LLC, Minneapolis, MN, USA.
Benjamin E RichCelcuity LLC, Minneapolis, MN, USA.
Ian A MacNeilCelcuity LLC, Minneapolis, MN, USA.
Abhijit DandapatCelcuity LLC, Minneapolis, MN, USA.
Sajjad M SoltaniCelcuity LLC, Minneapolis, MN, USA.
Samantha MyhreCelcuity LLC, Minneapolis, MN, USA.
Brian F SullivanCelcuity LLC, Minneapolis, MN, USA.
Carol A LangeDivision of Hematology, Oncology, and Transplantation, Departments of Medicine and Pharmacology and The Masonic Cancer Center, University of Minnesota, Minneapolis, MN, USA.
Leo T FurchtDepartment of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, MN, USA.
Lance G LaingCelcuity LLC, Minneapolis, MN, USA. LLaing@Celcuity.com.
University of Minnesota · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundApproximately 18-20% of all human breast cancers have overexpressed human epidermal growth factor receptor 2 (HER2). Standard clinical practice is to treat only overexpressed HER2 (HER2+) cancers with targeted anti-HER2 therapies. However, recent analyses of clinical trial data have found evidence that HER2-targeted therapies may benefit a sub-group of breast cancer patients with non-overexpressed HER2. This suggests that measurement of other biological factors associated with HER2 cancer, such as HER2 signaling pathway activity, should be considered as an alternative means of identifying patients eligible for HER2 therapies.

methodsA new biosensor-based test (CELx

resultsThe analytical sensitivity and analyte specificity of this method was demonstrated using ligands with high affinity and specificity for HER1 and HER3. The HER2-driven signaling quantified ranged 50-fold between the lowest and highest cell lines. The HER2+ cell lines were almost equally divided into high and low signaling test result groups, suggesting that little correlation exists between HER2 protein expression and HER2 signaling level. Unexpectedly, the highest HER2-driven signaling level recorded was with a HER2- cell line.

conclusionsMeasurement of HER2 signaling activity in the tumor cells of breast cancer patients is a feasible approach to explore as a biomarker to identify HER2-driven cancers not currently diagnosable with genomic techniques. The wide range of HER2-driven signaling levels measured suggests it may be possible to make a distinction between normal and abnormal levels of activity. Analytical validation studies and clinical trials treating HER2- patients with abnormal HER2-driven signaling would be required to evaluate the analytical and clinical validity of using this functional biomarker as a diagnostic test to select patients for treatment with HER2 targeted therapy. In clinical practice, this method would require patient specimens be delivered to and tested in a central lab.

Indexed as

Biomarkers, TumorBiosensing TechniquesBreast NeoplasmsDrug Resistance, NeoplasmErb-b2 Receptor Tyrosine KinasesFemaleGene Expression Regulation, NeoplasticHumansMCF-7 CellsPrognosisBiomarkers, TumorERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesBreast cancerBreast tumorCancer diagnosticCELx HSF TestHER2-negativeHER2-positiveOncologyPrimary epithelial cellsSignaling pathwayTargeted therapeutics

Identifiers

PMID28302091
PMCPMC5356237
OpenAlexW2596809090

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.