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

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ClinicalTrials.gov Identifier: NCT04246606
Recruitment Status : Recruiting
First Posted : January 29, 2020
Last Update Posted : May 8, 2020
Sponsor:
Collaborator:
Roche Diagnostics
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment
Breast Neoplasm Female Diagnostic Test: IHC4 score

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.

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Study Type : Observational
Estimated Enrollment : 155 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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-
Actual Study Start Date : April 24, 2020
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
ER+/HER2- infiltrating early breast cancer
Patients with ER+/HER2- infiltrating early breast cancer for which EndoPredict molecular signature was performed.
Diagnostic Test: IHC4 score

The IHC4 score is a prognostic tool that incorporates immunohistochemical parameters of ER (H-score), PR (% of positive cells), HER2 (positive or negative status), and Ki67 (% of positive cells).

IHC4 score, combined with nodal status and tumor grade, age, and the type of endocrine therapy (tamoxifen or aromatase inhibitors) provides a clinical score IHC4+C.

IHC4+C provides a prognostic risk of distant recurrence at 10 years for patients who underwent endocrine therapy for 5 years. IHC4+C defined three distinct risk categories:

  • <10%: low risk
  • [10-20%]: intermediate risk
  • >20%: high risk




Primary Outcome Measures :
  1. To assess the reproducibility of the IHC4 score testing performed in local pathology laboratory (i.e. real life) to in a central laboratory. [ Time Frame: 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 :
  1. To assess the inter-observer reproducibility of IHC4 scoring carry out by different local pathologists on digitalised slides. [ Time Frame: Day 1 ]
    Inter-observer reproducibility of IHC4 scoring carry out by different local pathologists on digitalised slides.

  2. Reproducibility of IHC4+C score compare to the molecular gold standard EPclin (Endopredict). [ Time Frame: 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).

  3. To assess the consistency of the IHC4 scoring performed by a pathologist to an automatic image recognition algorithm. [ Time Frame: Day 1 ]
    Inter-observer reproducibility of IHC4 scoring carry out by a pathologist to an automatic image recognition algorithm


Biospecimen Retention:   Samples Without DNA
Immunostaining slides for ER, PR, Ki67 and HER2 carry out on surgical resection


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with ER+/HER2- infiltrating early breast cancer for which EndoPredict molecular signature was performed.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04246606


Contacts
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Contact: Etienne Lonchamp, PhD 0033 1 85 34 36 24 e-lonchamp@unicancer.fr
Contact: Jérôme Lemonnier, PhD 0033 1 71 93 67 02 j-lemonnier@unicancer.fr

Locations
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France
Centre Antoine Lacassagne Recruiting
Nice, France, 06180
Principal Investigator: Juliette Haudebourg, MD         
Sponsors and Collaborators
UNICANCER
Roche Diagnostics
Investigators
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Principal Investigator: Juliette Haudebourg, MD Centre Antoine Lacassagne
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Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT04246606    
Other Study ID Numbers: TRA05-GEFPICS
First Posted: January 29, 2020    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by UNICANCER:
IHC4
IHC4+C
Endopredict
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases