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

NCT04246606 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 155

Last updated 2023-11-18

No results posted yet for this study

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).

Conditions

  • Breast Neoplasm Female

Interventions

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

Sponsors & Collaborators

  • Roche Diagnostics GmbH

    collaborator INDUSTRY

  • UNICANCER

    lead OTHER

Principal Investigators

  • Juliette Haudebourg, MD · Centre Antoine Lacassagne

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-24
Primary Completion
2023-09-30
Completion
2023-11-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04246606 on ClinicalTrials.gov