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

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

IHC4 score

Juliette Haudebourg, MD

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).

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.

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

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

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-

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.

Inter-observer reproducibility of IHC4 scoring carry out by different local pathologists on digitalised slides.

To assess the consistency of IHC4+C score (IHC4 combined with nodal status and tumor grade) to the molecular gold standard EPclin (Endopredict).

Inter-observer reproducibility of IHC4 scoring carry out by a pathologist to an automatic image recognition algorithm

Roche Diagnostics GmbH

UNICANCER

Distant recurrence-free survival (DRFS) between years 5 and 10 post-diagnosis of women with ER+, HER2- breast cancer who are classified as low risk according to their EPclin score and who did not receive extended endocrine therapy

Observational

Joyce O'Shaunessey, MD

The purpose of this study is to evaluate the impact of using EndoPredict® clinically to inform treatment decisions for extended endocrine therapy, and the subsequent impact on patient outcomes.

The EndoPredict® molecular test is validated to predict late distant recurrence after 5 years of endocrine therapy in women with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) early stage breast cancer, with or without treatment with adjuvant chemotherapy. The test provides an individualized EPclin score based on the tumor gene expression, tumor size and nodal status, and categorizes patients as High or Low risk of distant recurrence.

The primary objective of this study is to evaluate the distant recurrence-free survival (DRFS) at 5-10 years in patients with ER+/HER2- early stage breast cancer with EPclin Low scores that did not extend endocrine therapy.

Data collection is prospective and patient enrollment is expected to occur over 24 months. The study will enroll patients who are near the 5-year post-diagnosis time point when decisions on extending endocrine therapy are being made. Patient breast cancer tumors, stored from surgical collection after initial diagnosis, will be tested with EndoPredict and a report generated. The provider will convey the report results to the patient and establish a treatment plan to continue or forgo endocrine therapy. Patients will then be followed for 6 years with data collection every year, and outcomes (distant and local disease recurrence, second primary breast cancer, etc.) recorded.

The associations between outcomes and treatment, EPclin score and risk category, EP molecular score, and clinicopathologic features will be investigated in all patients and in subpopulations (node negative, node positive, treated with or without chemotherapy, etc.).

The primary objective of this study is to evaluate distant recurrence-free survival (DRFS) between years 5 and 10 post-diagnosis of women with ER+, HER2- breast cancer who are classified as low risk according to their EPclin score and who did not receive extended endocrine therapy.

EndoPredict® Extended Endocrine Trial (EXET)

EndoPredict® Extended Endocrine Trial (EXET): A Prospective Registry to Evaluate the Impact of EndoPredict® Test on Extended Endocrine Treatment Decisions and Patient Outcomes.

Compare previous chemotherapy treatment decisions to chemotherapy treatment recommendations based on EndoPredict® risk classification.

Repeat all primary and secondary objectives in subsets of patients based on variables such as clinicopathologic features and treatment.

The primary objective of this study is to evaluate distant recurrence-free survival (DRFS) between years 5 and 10 post-diagnosis of women with ER+, HER2- breast cancer who are classified as low risk according to their EPclin score and who did not receive extended endocrine therapy

Evaluate DRFS between years 5 and 10 post-diagnosis in women classified as low risk according to their EPclin who received extended endocrine therapy

Evaluate DRFS between years 5 and 10 post-diagnosis in women classified as high risk according to their EPclin score based on treatment decisions.

Evaluate the proportion of patients classified as EPclin low who forgo extending endocrine and the proportion of EPclin high who extend endocrine therapy beyond 5 years

Evaluate the proportion of patients who received adjuvant chemotherapy classified as EPclin low who forgo extending endocrine and those classified as EPclin high who extend endocrine therapy beyond 5 years

Evaluate disease-free survival in patients stratified based on EPclin risk classification and actual treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Concordance of the IHC4 Score Performed in Local or Central Laboratory to Endopredict in ER+/HER2- Breast Cancer	NCT04246606	Breast Neoplasm...	IHC4 score	18 Years -	UNICANCER
EndoPredict® Extended Endocrine Trial (EXET)	NCT04016935	Primary Invasiv...	Observational	18 Years -	Myriad Genetic Laboratories, Inc.
EndoPredict® Extended Endocrine Trial (EXET)	NCT04016935	Primary Invasiv...	Observational	18 Years -	Myriad Genetic Laboratories, Inc.

Spots Global Cancer Trial Database for endopredict

Every month we try and update this database with for endopredict cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for endopredict

Every month we try and update this database with for endopredict cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for endopredict cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.