EndoPredict® Extended Endocrine Trial (EXET)

May 10, 2022 updated by: Myriad Genetic Laboratories, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
855

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: 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
10 Years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: 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
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.
Time Frame: 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.
10 Years
Evaluate adherence to EndoPredict® test results when making decisions regarding extended endocrine therapy
Time Frame: 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
1 Year
Evaluate adherence to EndoPredict® test results when making decisions regarding extended endocrine therapy according to whether patients received adjuvant chemotherapy.
Time Frame: 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
1 Year
Evaluate disease-free survival in patients stratified based on EPclin risk classification and actual treatment.
Time Frame: 10 Years
Evaluate disease-free survival in patients stratified based on EPclin risk classification and actual treatment.
10 Years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Compare previous chemotherapy treatment decisions to chemotherapy treatment recommendations based on EndoPredict® risk classification.
Time Frame: 1 Year
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.
Time Frame: 10 Years
Repeat all primary and secondary objectives in subsets of patients based on variables such as clinicopathologic features and treatment.
10 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Myriad Genetic Laboratories, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joyce O'Shaunessey, MD, US Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 2, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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