EndoPredict® Extended Endocrine Trial (EXET)
- Conditions
- Primary Invasive Breast Cancer
- Interventions
- Other: Observational
- Registration Number
- NCT04016935
- Lead Sponsor
- Myriad Genetic Laboratories, Inc.
- Brief Summary
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
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.).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 855
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with primary invasive ER+ HER2- breast cancer Observational 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
- Primary Outcome Measures
Name Time Method Evaluate DRFS of women 5-10 years post diagnosis with ER+, HER2-breast cancer who are low risk according to their EPclin scores 10 Years 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
- Secondary Outcome Measures
Name Time Method 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 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. 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 adherence to EndoPredict® test results when making decisions regarding extended endocrine therapy 1 Year 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 adherence to EndoPredict® test results when making decisions regarding extended endocrine therapy according to whether patients received adjuvant chemotherapy. 1 Year 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. 10 Years Evaluate disease-free survival in patients stratified based on EPclin risk classification and actual treatment.
Trial Locations
- Locations (46)
UPMC Memorial
🇺🇸York, Pennsylvania, United States
AON Hematology Oncology Clinic
🇺🇸Baton Rouge, Louisiana, United States
Allegheny Health Network
🇺🇸Pittsburgh, Pennsylvania, United States
Magee-Women's Hospital of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center (UPMC)
🇺🇸Pittsburgh, Pennsylvania, United States
UPMC Hillman Cancer Center Passavant (HOA)
🇺🇸Pittsburgh, Pennsylvania, United States
UPMC - St. Clair Hospital - Integrated Cancer Services
🇺🇸Pittsburgh, Pennsylvania, United States
Tennessee Oncology
🇺🇸Nashville, Tennessee, United States
Providence
🇺🇸Burbank, California, United States
Akron General Medical Center
🇺🇸Akron, Ohio, United States
Minnesota Oncology Hematology
🇺🇸Minneapolis, Minnesota, United States
Florida Cancer Specialists
🇺🇸West Palm Beach, Florida, United States
Columbus Regional Research Institute
🇺🇸Columbus, Georgia, United States
UPMC Hillman Cancer Center Indiana
🇺🇸Indiana, Pennsylvania, United States
Summa Health
🇺🇸Akron, Ohio, United States
Hematology Oncology Associates of Central New York, PC
🇺🇸East Syracuse, New York, United States
Texas Oncology Sammons Cancer Center
🇺🇸Dallas, Texas, United States
UPMC Hillman Cancer Center - Moon
🇺🇸Coraopolis, Pennsylvania, United States
UPMC Hillman Cancer McKeesport
🇺🇸McKeesport, Pennsylvania, United States
UPMC Passavant North Cranberry (OHA)
🇺🇸Cranberry Township, Pennsylvania, United States
UPMC Hillman Cancer Center Passavant (OHA)
🇺🇸Pittsburgh, Pennsylvania, United States
UPMC Hillman Cancer Center Greenville
🇺🇸Greenville, Pennsylvania, United States
UPMC Hillman Cancer Center Monroeville
🇺🇸Monroeville, Pennsylvania, United States
UPMC Hillman Cancer Center Northwest
🇺🇸Seneca, Pennsylvania, United States
UPMC Hillman Cancer Center Washington
🇺🇸Washington, Pennsylvania, United States
UPMC Hillman Cancer Center Jefferson
🇺🇸West Mifflin, Pennsylvania, United States
Baptist Cancer Center
🇺🇸Memphis, Tennessee, United States
Texas Oncology
🇺🇸Tyler, Texas, United States
UPMC Hillman Cancer Center Arnold Palmer at Norwin
🇺🇸Irwin, Pennsylvania, United States
UPMC Hillman Cancer Center - Natrona Heights
🇺🇸Natrona Heights, Pennsylvania, United States
UPMC Hillman Cancer Center Uniontown
🇺🇸Uniontown, Pennsylvania, United States
UPMC Hillman Cancer Center Williamsport
🇺🇸Williamsport, Pennsylvania, United States
UPMC Hillman Cancer Center Murtha
🇺🇸Johnstown, Pennsylvania, United States
UPMC Hillman Cancer Center Horizon
🇺🇸Farrell, Pennsylvania, United States
UPMC Hillman Cancer Center Beaver
🇺🇸Beaver, Pennsylvania, United States
UPMC Hillman Cancer Center Upper St. Clair
🇺🇸Bethel Park, Pennsylvania, United States
UPMC Hillman Cancer Center New Castle
🇺🇸New Castle, Pennsylvania, United States
Ortenzio Cancer Center
🇺🇸Mechanicsburg, Pennsylvania, United States
UPMC Hillman Cancer Center Arnold Palmer at Mt. Pleasant
🇺🇸Mount Pleasant, Pennsylvania, United States
UPMC Hillman Cancer Center St Margaret
🇺🇸Pittsburgh, Pennsylvania, United States
Hope Cancer of Texas
🇺🇸Tyler, Texas, United States
Sutter Hematology and Oncology
🇺🇸Roseville, California, United States
New York Oncology Hematology
🇺🇸Clifton Park, New York, United States
Butler Health System Medical Oncology
🇺🇸Butler, Pennsylvania, United States
UPMC Hillman Cancer Center Erie
🇺🇸Erie, Pennsylvania, United States
Carolina Blood and Cancer Care Associates
🇺🇸Rock Hill, South Carolina, United States