EndoPredict® Extended Endocrine Trial (EXET)

Stopped early

Conditions studied: Primary Invasive Breast Cancer

In brief

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.

Key facts

Study ID

NCT04016935

Run by

Myriad Genetic Laboratories, Inc.

People needed

855

Starts

2019-07-02

Expected to finish

2022-03-31

Last updated by the study team

2022-05-17

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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

Where it is running

• Sutter Hematology and Oncology — Roseville, California, United States
• Florida Cancer Specialists — Fort Myers, Florida, United States
• Florida Cancer Specialists — St. Petersburg, Florida, United States
• Florida Cancer Specialists — Tallahassee, Florida, United States
• Florida Cancer Specialists — West Palm Beach, Florida, United States
• Columbus Regional Research Institute — Columbus, Georgia, United States
• AON Hematology Oncology Clinic — Baton Rouge, Louisiana, United States
• Minnesota Oncology Hematology — Minneapolis, Minnesota, United States
• New York Oncology Hematology — Albany, New York, United States
• New York Oncology Hematology — Albany, New York, United States
• New York Oncology Hematology — Clifton Park, New York, United States
• Hematology Oncology Associates of Central New York, PC — East Syracuse, New York, United States
• Akron General Medical Center — Akron, Ohio, United States
• Summa Health — Akron, Ohio, United States
• UPMC Hillman Cancer Center Beaver — Beaver, Pennsylvania, United States
• UPMC Hillman Cancer Center Upper St. Clair — Bethel Park, Pennsylvania, United States
• Butler Health System Medical Oncology — Butler, Pennsylvania, United States
• UPMC Hillman Cancer Center - Moon — Coraopolis, Pennsylvania, United States
• UPMC Passavant North Cranberry (OHA) — Cranberry Township, Pennsylvania, United States
• UPMC Hillman Cancer Center Erie — Erie, Pennsylvania, United States
• UPMC Hillman Cancer Center Horizon — Farrell, Pennsylvania, United States
• UPMC Hillman Cancer Center Greenville — Greenville, Pennsylvania, United States
• UPMC Hillman Cancer Center Indiana — Indiana, Pennsylvania, United States
• UPMC Hillman Cancer Center Arnold Palmer at Norwin — Irwin, Pennsylvania, United States
• Providence — Burbank, California, United States

Full record on ClinicalTrials.gov

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