Stopped: It was determined that we had sufficient enrollment and study data to explore the impact of the Endopredict test in endocrine therapy decision-making.
United States855 participantsStarted 2019-07-02
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Evaluate DRFS of women 5-10 years post diagnosis with ER+, HER2-breast cancer who are low risk according to their EPclin scores