Clinical trial · Observational
Concordance of the IHC4 Score Performed in Local or Central Laboratory to Endopredict in ER+/HER2- Breast Cancer
Retrospective Study Assessing the Concordance of the IHC4 Score Performed in Local Pathology Laboratory or in a Central Laboratory to a Molecular Gold Standard Test Endopredict in Breast Cancer Infiltrating ER+ HER2-
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Retrospective observational, multicentric study assessing the immunohistochemistry (IHC) based test IHC4 score in infiltrating early breast cancer: comparison of the score performed in local laboratory vs in a central laboratory and concordance with a molecular gold standard classifier (EndoPredict).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasm Female | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IHC4 score | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- ER+/HER2- infiltrating early breast cancer
- description
- Patients with ER+/HER2- infiltrating early breast cancer for which EndoPredict molecular signature was performed.
- interventionNames
- Diagnostic Test: IHC4 score
Primary outcomes (1)
- measure
- To assess the reproducibility of the IHC4 score testing performed in local pathology laboratory (i.e. real life) to in a central laboratory.
- timeFrame
- Day 1
- description
- Inter-laboratory concordance rate of IHC4 score performed in a local laboratory versus central laboratory. The equivalence of the two methods is defined as a ≥90% concordance rate.
Secondary outcomes (3)
- measure
- To assess the inter-observer reproducibility of IHC4 scoring carry out by different local pathologists on digitalised slides.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Sample selection criteria: 1. Prior information of the patient. 2. Histologically proven invasive breast cancer, 3. ER-positive breast cancer, according to the following criteria: ER ≥10 % (local assessment) 4. HER2-negative tumor by IHC (score 0 or 1+) and/or fluorescent in situ hybridization (FISH)/chromogenic in situ hybridization (CISH) negative (local assessment) 5. IHC staining slides for ER, PR, KI67 and HER2 carry out on surgical resection according to local protocol available, 6. In situ hybridization (ISH) staining for HER2 carry out on surgical resection, in case of IHC 2+ for HER2 immunostaining 7. EndoPredict test results available (EPclin), 8. Formalin-fixed and paraffin-embedded (FFPE) block from surgical resection of the primary tumor available, 9. Patient ≥18 years old.
References
Publications (0)
Data not yet available