Status:
TERMINATED
EndoPredict® Extended Endocrine Trial (EXET)
Lead Sponsor:
Myriad Genetic Laboratories, Inc.
Conditions:
Primary Invasive Breast Cancer
Eligibility:
FEMALE
18+ years
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 recepto...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 2 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2022
Estimated Enrollment :
855 Patients enrolled
Trial Details
Trial ID
NCT04016935
Start Date
July 2 2019
End Date
March 31 2022
Last Update
May 17 2022
Active Locations (52)
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1
Providence
Burbank, California, United States, 91505
2
Sutter Hematology and Oncology
Roseville, California, United States, 95661
3
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
4
Florida Cancer Specialists
St. Petersburg, Florida, United States, 33705