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.

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.

Study Overview

• Status: Terminated
• Conditions: Primary Invasive Breast Cancer
• Intervention / Treatment: Other: Observational

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.).

• Study Type: Observational
• Enrollment (Actual): 855

Contacts and Locations

Study Locations

• United States
  • California
    • Burbank, California, United States, 91505
      • Providence
    • Roseville, California, United States, 95661
      • Sutter Hematology and Oncology
  • Florida
    • Fort Myers, Florida, United States, 33901
      • Florida Cancer Specialists
    • Saint Petersburg, Florida, United States, 33705
      • Florida Cancer Specialists
    • Tallahassee, Florida, United States, 32308
      • Florida Cancer Specialists
    • West Palm Beach, Florida, United States, 33401
      • Florida Cancer Specialists
  • Georgia
    • Columbus, Georgia, United States, 31904
      • Columbus Regional Research Institute
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • AON Hematology Oncology Clinic
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Minnesota Oncology Hematology
  • New York
    • Albany, New York, United States, 12206
      • New York Oncology Hematology
    • Albany, New York, United States, 12208
      • New York Oncology Hematology
    • Clifton Park, New York, United States, 12065
      • New York Oncology Hematology
    • East Syracuse, New York, United States, 13057
      • Hematology Oncology Associates of Central New York, PC
  • Ohio
    • Akron, Ohio, United States, 44302
      • Akron General Medical Center
    • Akron, Ohio, United States, 44304
      • Summa Health
  • Pennsylvania
    • Beaver, Pennsylvania, United States, 15009
      • UPMC Hillman Cancer Center Beaver
    • Bethel Park, Pennsylvania, United States, 15102
      • UPMC Hillman Cancer Center Upper St. Clair
    • Butler, Pennsylvania, United States, 16001
      • Butler Health System Medical Oncology
    • Coraopolis, Pennsylvania, United States, 15108
      • UPMC Hillman Cancer Center - Moon
    • Cranberry Township, Pennsylvania, United States, 16066
      • UPMC Passavant North Cranberry (OHA)
    • Erie, Pennsylvania, United States, 16505
      • UPMC Hillman Cancer Center Erie
    • Farrell, Pennsylvania, United States, 16121
      • UPMC Hillman Cancer Center Horizon
    • Greenville, Pennsylvania, United States, 16125
      • UPMC Hillman Cancer Center Greenville
    • Indiana, Pennsylvania, United States, 15701
      • UPMC Hillman Cancer Center Indiana
    • Irwin, Pennsylvania, United States, 15642
      • UPMC Hillman Cancer Center Arnold Palmer at Norwin
    • Johnstown, Pennsylvania, United States, 15901
      • UPMC Hillman Cancer Center Murtha
    • McKeesport, Pennsylvania, United States, 15132
      • UPMC Hillman Cancer McKeesport
    • Mechanicsburg, Pennsylvania, United States, 17050
      • Ortenzio Cancer Center
    • Monroeville, Pennsylvania, United States, 15146
      • UPMC Hillman Cancer Center Monroeville
    • Mount Pleasant, Pennsylvania, United States, 15666
      • UPMC Hillman Cancer Center Arnold Palmer at Mt. Pleasant
    • Natrona Heights, Pennsylvania, United States, 15065
      • UPMC Hillman Cancer Center - Natrona Heights
    • New Castle, Pennsylvania, United States, 16105
      • UPMC Hillman Cancer Center New Castle
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny Health Network
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee-Women's Hospital of UPMC
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center (UPMC)
    • Pittsburgh, Pennsylvania, United States, 15215
      • UPMC Hillman Cancer Center St Margaret
    • Pittsburgh, Pennsylvania, United States, 15237
      • UPMC Hillman Cancer Center Passavant (HOA)
    • Pittsburgh, Pennsylvania, United States, 15237
      • UPMC Hillman Cancer Center Passavant (OHA)
    • Pittsburgh, Pennsylvania, United States, 15243
      • UPMC - St. Clair Hospital - Integrated Cancer Services
    • Seneca, Pennsylvania, United States, 16346
      • UPMC Hillman Cancer Center Northwest
    • Uniontown, Pennsylvania, United States, 15401
      • UPMC Hillman Cancer Center Uniontown
    • Washington, Pennsylvania, United States, 15301
      • UPMC Hillman Cancer Center Washington
    • West Mifflin, Pennsylvania, United States, 15122
      • UPMC Hillman Cancer Center Jefferson
    • Williamsport, Pennsylvania, United States, 17701
      • UPMC Hillman Cancer Center Williamsport
    • York, Pennsylvania, United States, 17408
      • UPMC Memorial
  • South Carolina
    • Lancaster, South Carolina, United States, 29732
      • Carolina Blood and Cancer Care Associates
    • Rock Hill, South Carolina, United States, 29732
      • Carolina Blood and Cancer Care Associates
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Baptist Cancer Center
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology
  • Texas
    • Dallas, Texas, United States, 75246
      • Texas Oncology Sammons Cancer Center
    • Tyler, Texas, United States, 75702
      • Texas Oncology
    • Tyler, Texas, United States, 75701
      • Hope Cancer of Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Approximately 2,800 patients with ER+, HER2- breast cancer will be enrolled in this study across multiple sites. These patients will include both node-positive and node negative patients, with a minimum of 1673 patients with low-risk EPclin scores including 1,505 who forego extended endocrine therapy. Patients will be eligible for the study if they meet the following inclusion criteria.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with primary invasive ER+ HER2- breast cancer; 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; Observational

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare previous chemotherapy treatment decisions to chemotherapy treatment recommendations based on EndoPredict® risk classification.	Compare previous chemotherapy treatment decisions to chemotherapy treatment recommendations based on EndoPredict® risk classification.	1 Year
Repeat all primary and secondary objectives in subsets of patients based on variables such as clinicopathologic features and treatment.	Repeat all primary and secondary objectives in subsets of patients based on variables such as clinicopathologic features and treatment.	10 Years

Collaborators and Investigators

• Sponsor: Myriad Genetic Laboratories, Inc.
• Investigators: Principal Investigator: Joyce O'Shaunessey, MD, US Oncology

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 2, 2019
• Primary Completion (ACTUAL): March 31, 2022
• Study Completion (ACTUAL): March 31, 2022

Study Registration Dates

• First Submitted: June 26, 2019
• First Submitted That Met QC Criteria: July 9, 2019
• First Posted (ACTUAL): July 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 10, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Neoplasms; Breast Neoplasms; Skin Diseases; Neoplasms by Site; Breast Diseases; Extended Endocrine Therapy; Additional Relevant MeSH terms:; ER+ and HER2- Breast Cancer patients; EndoPredict
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: ONC-010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No