Breast CancerNCT02654444
Semi-Quantification of Her2/Neu Protein Expression in Formalin Fixed, Paraffin-Embedded Normal and Neoplastic Tissue
An observational study of Breast Cancer, run by Applied Spectral Imaging Ltd..
Trial summary
The purpose of the study is the identification and quantification of protein expression level in breast cancer tissues. The imaging system is intended for diagnostic use as an aid to the pathologist in the detection, counting and classifying her2 immunohistochemical (IHC) stained samples. Read more about this study
- Who is it for?
- Ages 21 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- May 2013to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women having breast cancer
Who may be able to join
- Women having breast cancer aged 21 and up
- Borders of tumor nuclei are distinguishable
- Nuclei should have good integrity
- Background should not contain particles that interfere with the analysis
Who cannot join
- Slides that cannot be analyzed manually by Pathologist
About this study
Official title: Concordance Study of Her2 Expression Level in Breast Cancer Tissues
The purpose of the study is the identification and quantification of protein expression level in breast cancer tissues.
The imaging system is intended for diagnostic use as an aid to the pathologist in the detection, counting and classifying her2 immunohistochemical (IHC) stained samples.
Read the detailed description
The anti Her2/neu Kit is a semi-quantitative immunohistochemical (IHC) assay to identify the Human Epithelial growth factor receptor (Her2/neu) expression in formalin-fixed, paraffin-embedded human breast cancer tissue specimens. Results from the Her-2 test is indicated as an aid in the assessment of patients for whom HERCEPTIN® (Trastuzumab) treatment is being considered. While the Her-2 kit provides the antibodies that offer direct visualization and semi-quantification of the HER2 protein expression through a brightfield microscope, the GenASIs GoPath system is designed to complement the routine workflow of the pathologist in the review of immunohistochemically stained histologic slides.
- Conditions
- Breast Cancer
- Keywords
- Immunohistochemical (IHC), Her2/Neu, Breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GenASIs HiPath IHC #1 | Expression of HER2 antibody. Semi-Quantitative value | |
| GenASIs HiPath IHC #2 | Expression of HER2 antibody. Semi-Quantitative value | |
| GenASIs HiPath IHC #3 | Expression of HER2 antibody. Semi-Quantitative value |
What is being measured
The primary outcome is the main question the study is designed to answer.
IVD study of HER2 IHC samples: Accuracy of analysis
Comparison tests (accuracy) between manual and automatic analysis of antibody expressions. The results from the automatic counting from the clinical studies will be compared to the manual counting analysis.
The study is declared Success if the lower limit of two-sided 95% exact Binomial confidence interval for I. Positive, Negative and Overall agreement with manual count will be at least 85% II. Equivocal agreement with manual count will be at least 80%
Measured: 1 Day
IVD study of HER2 IHC samples: Repeatability & Reproducibility of analysis
Repeatability \& Reproducibility tests of system analysis of antibody expressions. R\&R acceptance criteria of HER2 are related to the average agreement for between runs, between days and between systems The R\&R part of the study will be declared "Success" based on the two-level HER2/neu outcome (negative=0 \& 1+, positive=2+ \& 3+), if positive and negative average agreements will be at least 85%
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study startMay 2013
- Primary completionMay 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Applied Spectral Imaging Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02654444
- Sponsor's protocol ID
- ASI-HER2-IHC
- Status last verified
- Nov 2026
- First submitted
- 5 Feb 2015
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concordance Study of Her2 Expression Level in Breast Cancer Tissues
- ClinicalTrials.gov ID
- NCT02654444
- Acronym / sponsor ID
- ASI-HER2-IHC
- Conditions
- Breast Cancer
- Keywords
- Immunohistochemical (IHC), Her2/Neu, Breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Applied Spectral Imaging Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 13 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is the identification and quantification of protein expression level in breast cancer tissues.
The imaging system is intended for diagnostic use as an aid to the pathologist in the detection, counting and classifying her2 immunohistochemical (IHC) stained samples.
Detailed description
The anti Her2/neu Kit is a semi-quantitative immunohistochemical (IHC) assay to identify the Human Epithelial growth factor receptor (Her2/neu) expression in formalin-fixed, paraffin-embedded human breast cancer tissue specimens. Results from the Her-2 test is indicated as an aid in the assessment of patients for whom HERCEPTIN® (Trastuzumab) treatment is being considered. While the Her-2 kit provides the antibodies that offer direct visualization and semi-quantification of the HER2 protein expression through a brightfield microscope, the GenASIs GoPath system is designed to complement the routine workflow of the pathologist in the review of immunohistochemically stained histologic slides.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GenASIs HiPath IHC #1 | – | –Expression of HER2 antibody. Semi-Quantitative value |
| GenASIs HiPath IHC #2 | – | –Expression of HER2 antibody. Semi-Quantitative value |
| GenASIs HiPath IHC #3 | – | –Expression of HER2 antibody. Semi-Quantitative value |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women having breast cancer
Key inclusion criteria (4 listed)
- Women having breast cancer aged 21 and up
- Borders of tumor nuclei are distinguishable
- Nuclei should have good integrity
- Background should not contain particles that interfere with the analysis
Key exclusion criteria (1 listed)
- Slides that cannot be analyzed manually by Pathologist
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
IVD study of HER2 IHC samples: Accuracy of analysis
Time frame: 1 Day
Comparison tests (accuracy) between manual and automatic analysis of antibody expressions. The results from the automatic counting from the clinical studies will be compared to the manual counting analysis. The study is declared Success if the lower limit of two-sided 95% exact Binomial confidence interval for I. Positive, Negative and Overall agreement with manual count will be at least 85% II. Equivocal agreement with manual count will be at least 80%
IVD study of HER2 IHC samples: Repeatability & Reproducibility of analysis
Time frame: 1 Day
Repeatability \& Reproducibility tests of system analysis of antibody expressions. R\&R acceptance criteria of HER2 are related to the average agreement for between runs, between days and between systems The R\&R part of the study will be declared "Success" based on the two-level HER2/neu outcome (negative=0 \& 1+, positive=2+ \& 3+), if positive and negative average agreements will be at least 85%
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
Related trials for Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
Not yet recruitingPhase 1
A Study to Evaluate the Effects of GDC-4198 in Combination With Letrozole, Fulvestrant, or Giredestrant in Participants With Locally Advanced or Metastatic Hormone Receptor-Positive, HER2-Negatve Breast Cancer
Advanced or Metastatic Breast Cancer
Not yet recruitingPhase 2
Netupitant/Palonosetron for Prevention of Nausea and Vomiting in Breast Cancer ADC Therapy
Breast Cancer
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-)
Not yet recruiting
Molecular Subtype-Guided Postoperative Radiotherapy for Phyllodes Tumor of the Breast
Radiotherapy, Adjuvant, Phyllodes Breast Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Applied Spectral Imaging Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IVD study of HER2 IHC samples: Accuracy of analysis (time frame: 1 Day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026; AzTrials last refreshed its copy on 6 Nov 2026.