Clinical trial · Observational
EndoPredict® Extended Endocrine Trial (EXET)
EndoPredict® Extended Endocrine Trial (EXET): A Prospective Registry to Evaluate the Impact of EndoPredict® Test on Extended Endocrine Treatment Decisions and Patient Outcomes.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): It was determined that we had sufficient enrollment and study data to explore the impact of the Endopredict test in endocrine therapy decision-making.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Invasive Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Observational | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with primary invasive ER+ HER2- breast cancer
- description
- Distant recurrence-free survival (DRFS) between years 5 and 10 post-diagnosis of women with ER+, HER2- breast cancer who are classified as low risk according to their EPclin score and who did not receive extended endocrine therapy
- interventionNames
- Other: Observational
Primary outcomes (1)
- measure
- Evaluate DRFS of women 5-10 years post diagnosis with ER+, HER2-breast cancer who are low risk according to their EPclin scores
- timeFrame
- 10 Years
- description
- The primary objective of this study is to evaluate distant recurrence-free survival (DRFS) between years 5 and 10 post-diagnosis of women with ER+, HER2- breast cancer who are classified as low risk according to their EPclin score and who did not receive extended endocrine therapy
Secondary outcomes (5)
- measure
- Evaluate DRFS between years 5 and 10 post-diagnosis in women classified as low risk according to their EPclin who received extended endocrine therapy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available