Clinical trial · Observational
A Prospective, Multicenter Registry to Observe the Treatment Patterns, Clinical Outcomes, and Decision-Making in Patients With Early Breast Cancer Eligible for EndoPredict® Testing
NCT07389408CI-TRIAL-00102465PRELUDErecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study is planned to observe and document the therapeutic decision-making process, treatment protocols, and clinical outcomes in patients with luminal breast cancer, whether they have undergone EndoPredict® testing or not
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Adenocarcinoma | Breast Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Non-metastatic breast cancer N0-N1 patients eligible for EndoPredict testing
- description
- Subjects diagnosed with non-metastatic invasive breast cancer, pT1-pT3, with 0 to 3 positive axillary lymph nodes, ER-positive, HER2-negative, that have not received neo-adjuvant chemotherapy and therefore are eligible for EndoPredict® testing. No intervention is planned, as this is an observational study and treatment of patients will not be changed due to their participation in the study.
Primary outcomes (4)
- measure
- Distant relapse free survival (DRFS)
- timeFrame
- 5- and 10-years
- description
- To collect and evaluate distant relapse-free survival (DRFS) at 5 and 10 years in patients with luminal breast cancer, with analyses stratified by EPclin risk group among participants who undergo EndoPredict® testing.
- measure
- Overall Survival (OS)
- timeFrame
- 5- and 10-years
- description
- To collect and evaluate overall survival (OS) at 5 and 10 years in patients with luminal breast cancer, with analyses stratified by EPclin risk group among participants who undergo EndoPredict® testing.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years old. * Histological diagnosis of invasive breast cancer. * T1-T3 tumor size. * 0-3 positive axillary lymph nodes. * Documented ER-positive tumor by immunohistochemistry (≥1% or Allred Score: ≥3/8 or H-score: ≥50/ 300) * Documented HER2-negative tumor by immunohistochemistry and/or in situ hybridization * Subject with signed and dated informed consent form. Exclusion Criteria: * History of another primary malignancy within the last 5 years, except for resected non-melanoma skin cancer. * Pre-operative chemotherapy administered. * Subject without signed and dated informed consent form.
References
Publications (0)
Data not yet available
No reference posted for this study.