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

NCT04246606 | Completed

• 1 other identifier: TRA05-GEFPICS
• Study Type: observational
• Target: 155
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Neoplasm Female

Keywords

IHC4; IHC4+C; Endopredict

Outcome Measures

Primary Outcomes (1)

• To assess the reproducibility of the IHC4 score testing performed in local pathology laboratory (i.e. real life) to in a central laboratory.

  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.

  Day 1

Secondary Outcomes (3)

• To assess the inter-observer reproducibility of IHC4 scoring carry out by different local pathologists on digitalised slides.

  Day 1

• Reproducibility of IHC4+C score compare to the molecular gold standard EPclin (Endopredict).

  Day 1

• To assess the consistency of the IHC4 scoring performed by a pathologist to an automatic image recognition algorithm.

  Day 1

Study Arms (1)

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

Interventions

IHC4 score DIAGNOSTIC_TEST

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

ER+/HER2- infiltrating early breast cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ER+/HER2- infiltrating early breast cancer for which EndoPredict molecular signature was performed.

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• UNICANCER: lead
• Roche Diagnostics GmbH: collaborator

Study Sites (1)

Centre Antoine Lacassagne

Nice, 06180, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Immunostaining slides for ER, PR, Ki67 and HER2 carry out on surgical resection

Study Officials

• Juliette Haudebourg, MD

  Centre Antoine Lacassagne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: January 29, 2020
• Study Start: April 24, 2020
• Primary Completion: September 30, 2023
• Study Completion: November 1, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

FR (1)