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Brief Title: EndoPredict® Extended Endocrine Trial (EXET)
Official Title: EndoPredict® Extended Endocrine Trial (EXET): A Prospective Registry to Evaluate the Impact of EndoPredict® Test on Extended Endocrine Treatment Decisions and Patient Outcomes.
Study ID: NCT04016935
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.).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Providence, Burbank, California, United States
Sutter Hematology and Oncology, Roseville, California, United States
Florida Cancer Specialists, Fort Myers, Florida, United States
Florida Cancer Specialists, Saint 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
UPMC Hillman Cancer Center Murtha, Johnstown, Pennsylvania, United States
UPMC Hillman Cancer McKeesport, McKeesport, Pennsylvania, United States
Ortenzio Cancer Center, Mechanicsburg, Pennsylvania, United States
UPMC Hillman Cancer Center Monroeville, Monroeville, Pennsylvania, United States
UPMC Hillman Cancer Center Arnold Palmer at Mt. Pleasant, Mount Pleasant, Pennsylvania, United States
UPMC Hillman Cancer Center - Natrona Heights, Natrona Heights, Pennsylvania, United States
UPMC Hillman Cancer Center New Castle, New Castle, Pennsylvania, 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 St Margaret, Pittsburgh, Pennsylvania, United States
UPMC Hillman Cancer Center Passavant (HOA), Pittsburgh, Pennsylvania, United States
UPMC Hillman Cancer Center Passavant (OHA), Pittsburgh, Pennsylvania, United States
UPMC - St. Clair Hospital - Integrated Cancer Services, Pittsburgh, Pennsylvania, United States
UPMC Hillman Cancer Center Northwest, Seneca, Pennsylvania, United States
UPMC Hillman Cancer Center Uniontown, Uniontown, Pennsylvania, United States
UPMC Hillman Cancer Center Washington, Washington, Pennsylvania, United States
UPMC Hillman Cancer Center Jefferson, West Mifflin, Pennsylvania, United States
UPMC Hillman Cancer Center Williamsport, Williamsport, Pennsylvania, United States
UPMC Memorial, York, Pennsylvania, United States
Carolina Blood and Cancer Care Associates, Lancaster, South Carolina, United States
Carolina Blood and Cancer Care Associates, Rock Hill, South Carolina, United States
Baptist Cancer Center, Memphis, Tennessee, United States
Tennessee Oncology, Nashville, Tennessee, United States
Texas Oncology Sammons Cancer Center, Dallas, Texas, United States
Hope Cancer of Texas, Tyler, Texas, United States
Texas Oncology, Tyler, Texas, United States
Name: Joyce O'Shaunessey, MD
Affiliation: US Oncology
Role: PRINCIPAL_INVESTIGATOR