EndoPredict® Extended Endocrine Trial (EXET)

NCT04016935 | Terminated

• 1 other identifier: ONC-010
• Study Type: observational
• Target: 855
• Locations: 1 country
• Sites: 52

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.

Conditions

Primary Invasive Breast Cancer

Keywords

ER+ and HER2- Breast Cancer patients; Extended Endocrine Therapy; EndoPredict; Additional Relevant MeSH terms:; Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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.

  10 Years

• Evaluate adherence to EndoPredict® test results when making decisions regarding extended endocrine therapy

  1 Year

• Evaluate adherence to EndoPredict® test results when making decisions regarding extended endocrine therapy according to whether patients received adjuvant chemotherapy.

  1 Year

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

  10 Years

Other Outcomes (2)

• 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.

  10 Years

Study Arms (1)

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

Interventions

Observational OTHER

Observational

Patients with primary invasive ER+ HER2- breast cancer

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 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.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Myriad Genetic Laboratories, Inc.: lead

Study Sites (52)

Providence

Burbank, California, 91505, United States

Location

Sutter Hematology and Oncology

Roseville, California, 95661, United States

Location

Florida Cancer Specialists

Fort Myers, Florida, 33901, United States

Location

Florida Cancer Specialists

St. Petersburg, Florida, 33705, United States

Location

Florida Cancer Specialists

Tallahassee, Florida, 32308, United States

Location

Florida Cancer Specialists

West Palm Beach, Florida, 33401, United States

Location

Columbus Regional Research Institute

Columbus, Georgia, 31904, United States

Location

AON Hematology Oncology Clinic

Baton Rouge, Louisiana, 70809, United States

Location

Minnesota Oncology Hematology

Minneapolis, Minnesota, 55404, United States

Location

New York Oncology Hematology

Albany, New York, 12206, United States

Location

New York Oncology Hematology

Albany, New York, 12208, United States

Location

New York Oncology Hematology

Clifton Park, New York, 12065, United States

Location

Hematology Oncology Associates of Central New York, PC

East Syracuse, New York, 13057, United States

Location

Akron General Medical Center

Akron, Ohio, 44302, United States

Location

Summa Health

Akron, Ohio, 44304, United States

Location

UPMC Hillman Cancer Center Beaver

Beaver, Pennsylvania, 15009, United States

Location

UPMC Hillman Cancer Center Upper St. Clair

Bethel Park, Pennsylvania, 15102, United States

Location

Butler Health System Medical Oncology

Butler, Pennsylvania, 16001, United States

Location

UPMC Hillman Cancer Center - Moon

Coraopolis, Pennsylvania, 15108, United States

Location

UPMC Passavant North Cranberry (OHA)

Cranberry Township, Pennsylvania, 16066, United States

Location

UPMC Hillman Cancer Center Erie

Erie, Pennsylvania, 16505, United States

Location

UPMC Hillman Cancer Center Horizon

Farrell, Pennsylvania, 16121, United States

Location

UPMC Hillman Cancer Center Greenville

Greenville, Pennsylvania, 16125, United States

Location

UPMC Hillman Cancer Center Indiana

Indiana, Pennsylvania, 15701, United States

Location

UPMC Hillman Cancer Center Arnold Palmer at Norwin

Irwin, Pennsylvania, 15642, United States

Location

UPMC Hillman Cancer Center Murtha

Johnstown, Pennsylvania, 15901, United States

Location

UPMC Hillman Cancer McKeesport

McKeesport, Pennsylvania, 15132, United States

Location

Ortenzio Cancer Center

Mechanicsburg, Pennsylvania, 17050, United States

Location

UPMC Hillman Cancer Center Monroeville

Monroeville, Pennsylvania, 15146, United States

Location

UPMC Hillman Cancer Center Arnold Palmer at Mt. Pleasant

Mount Pleasant, Pennsylvania, 15666, United States

Location

UPMC Hillman Cancer Center - Natrona Heights

Natrona Heights, Pennsylvania, 15065, United States

Location

UPMC Hillman Cancer Center New Castle

New Castle, Pennsylvania, 16105, United States

Location

Allegheny Health Network

Pittsburgh, Pennsylvania, 15212, United States

Location

Magee-Women's Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Pittsburgh Medical Center (UPMC)

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC Hillman Cancer Center St Margaret

Pittsburgh, Pennsylvania, 15215, United States

Location

UPMC Hillman Cancer Center Passavant (HOA)

Pittsburgh, Pennsylvania, 15237, United States

Location

UPMC Hillman Cancer Center Passavant (OHA)

Pittsburgh, Pennsylvania, 15237, United States

Location

UPMC - St. Clair Hospital - Integrated Cancer Services

Pittsburgh, Pennsylvania, 15243, United States

Location

UPMC Hillman Cancer Center Northwest

Seneca, Pennsylvania, 16346, United States

Location

UPMC Hillman Cancer Center Uniontown

Uniontown, Pennsylvania, 15401, United States

Location

UPMC Hillman Cancer Center Washington

Washington, Pennsylvania, 15301, United States

Location

UPMC Hillman Cancer Center Jefferson

West Mifflin, Pennsylvania, 15122, United States

Location

UPMC Hillman Cancer Center Williamsport

Williamsport, Pennsylvania, 17701, United States

Location

UPMC Memorial

York, Pennsylvania, 17408, United States

Location

Carolina Blood and Cancer Care Associates

Lancaster, South Carolina, 29732, United States

Location

Carolina Blood and Cancer Care Associates

Rock Hill, South Carolina, 29732, United States

Location

Baptist Cancer Center

Memphis, Tennessee, 38120, United States

Location

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

Texas Oncology Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

Hope Cancer of Texas

Tyler, Texas, 75701, United States

Location

Texas Oncology

Tyler, Texas, 75702, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Joyce O'Shaunessey, MD

  US Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: July 12, 2019
• Study Start: July 2, 2019
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (52)