EndoPredict® Extended Endocrine Trial (EXET)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.).

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

Conditions
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Primary Invasive Breast Cancer

Intervention / Treatment
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* Other: Observational


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female At least 18 years of age at time of enrollment Able to provide informed consent ER+, HER2- breast tumor Stage T1-T3 Currently receiving endocrine therapy Are between 4 and 6.5 years post-invasive breast cancer diagnosis Have all available information to produce an EPclin score, including treatment-naïve tumor stage, nodal status, and sufficient amount of remaining tissue from biopsy or resection to perform genomic testing (section 9) Patient and physician are willing to consider a change in endocrine therapy Exclusion Criteria: Metastatic disease or currently active additional cancer diagnosis (except non- melanoma skin cancer) or any second primary breast cancer (includes ductal and/or lobular carcinoma in situ) Patient received systemic chemotherapy within 1 year of enrollment Currently enrolled in an interventional clinical trial or other clinical trial that precludes freely making decisions regarding extended endocrine therapy More than 3 positive nodes Received neo-adjuvant treatment (new-adjuvant chemotherapy or neo-adjuvant endocrine therapy) Are beyond 7 years post-breast cancer diagnosis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with primary invasive ER+ HER2- breast cancer<br>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 | Other: Observational<br>* Observational<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate DRFS of women 5-10 years post diagnosis with ER+, HER2-breast cancer who are low risk according to their EPclin scores | 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 | 10 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 low risk according to their EPclin who received extended endocrine therapy | 10 Years | 
| 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 DRFS between years 5 and 10 post-diagnosis in women classified as high risk according to their EPclin score based on treatment decisions. | 10 Years | 
| Evaluate adherence to EndoPredict® test results when making decisions regarding extended endocrine therapy | 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 | 1 Year | 
| Evaluate adherence to EndoPredict® test results when making decisions regarding extended endocrine therapy according to whether patients received adjuvant chemotherapy. | 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 | 1 Year | 
| Evaluate disease-free survival in patients stratified based on EPclin risk classification and actual treatment. | Evaluate disease-free survival in patients stratified based on EPclin risk classification and actual treatment. | 10 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ER+ and HER2- Breast Cancer patients, Extended Endocrine Therapy, EndoPredict, Additional Relevant MeSH terms:, Breast Neoplasms, Neoplasms by Site, Neoplasms, Breast Diseases, Skin Diseases