Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-24 @ 10:07 PM
NCT ID:
NCT04016935
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04016935
Study Brief:
Protocol Section:
NCT04016935