Concordance of the IHC4 Score Performed in Local or Central Laboratory to Endopredict in ER+/HER2- Breast Cancer

Completed

• Conditions: Breast Neoplasm Female
• Interventions: Diagnostic Test: IHC4 score

• Registration Number: NCT04246606
• Lead Sponsor: UNICANCER

Brief Summary

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).

Detailed Description

The IHC4 prognostic signature is an algorithm based on a combination of biomarkers evaluated in immunohistochemistry and anatomical-clinical parameters. Immunohistochemistry is routinely performed as a diagnostic procedure for estrogen receptor (ER; H-score 0-300), progesterone receptor (PR; % of marked cells), HER2 (positive vs negative status) and Ki67 (% of marked cells evaluated by counting). Clinical parameters include lymph node status (0N+, 1-3N+, \>3N+, \>3N+), tumour size in mm (≤10mm, 11-20, 21-50, \>50mm), histologic grade (1, 2, 3), patient's age at diagnosis (\<65 years, ≥65 years), and type of treatment (anti-estrogen or aromatase inhibitors).

The method for reading and scoring conditions is very precise and currently guarantee the validity of the test (validated centrally in TransATAC). However, there is not yet an open access web platform available for the calculation of the IHC4 score, due to the prior need for homogenisation of the interpretation of immunochemistry (standardisation of the protocol) to generate a reliable and validated IHC4 under decentralised "real life" conditions. There is currently few published data on the weight of technical parameters (antibody clones, automaton type, etc.) or interpretation methods (scoring) in the calculation of the IHC4 score (IHC4 robustness). However, only one study, published recently, shows a good tolerance of the test to variations in technical protocol or reading.

In this context, a study coordinated by the GEFPICS group, composed of expert pathologists in breast cancer, has been set up to better define the robustness and the scope of IHC4 score. These project will assess 2 main aspects: (i) validate the local "real life" technique for the calculation of the IHC4 score; and (ii) homogenise the IHC reading method (especially for Ki67), on a cohort of cases from the GEFPICS, tested in a prognostic molecular signatures.

Study Timeline

• Study First Submitted: 2020-01-23
• Study First Submitted QC: 2020-01-27
• Study First Posted: 2020-01-29
• Study Start: 2020-04-24
• Primary Completion: 2023-09-30
• Status Verified: 2023-11
• Study Completion: 2023-11-01
• Last Update Submitted: 2023-11-17
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 155

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ER+/HER2- infiltrating early breast cancer	IHC4 score	Patients with ER+/HER2- infiltrating early breast cancer for which EndoPredict molecular signature was performed.

Primary Outcome Measures

Name	Time	Method
To assess the reproducibility of the IHC4 score testing performed in local pathology laboratory (i.e. real life) to in a central laboratory.	Day 1	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 Outcome Measures

Name	Time	Method
To assess the inter-observer reproducibility of IHC4 scoring carry out by different local pathologists on digitalised slides.	Day 1	Inter-observer reproducibility of IHC4 scoring carry out by different local pathologists on digitalised slides.
Reproducibility of IHC4+C score compare to the molecular gold standard EPclin (Endopredict).	Day 1	To assess the consistency of IHC4+C score (IHC4 combined with nodal status and tumor grade) to the molecular gold standard EPclin (Endopredict).
To assess the consistency of the IHC4 scoring performed by a pathologist to an automatic image recognition algorithm.	Day 1	Inter-observer reproducibility of IHC4 scoring carry out by a pathologist to an automatic image recognition algorithm

Trial Locations

Locations (1)

Centre Antoine Lacassagne; 🇫🇷 Nice, France