NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

CompletedN/A

Sponsor: UNICANCER

Conditions: Breast Neoplasm Female

Interventions: IHC4 score

Countries: France

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).

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility 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.

Locations (1)

Nice, France