Clinical trial · Observational
Parallel Comparison of 18 Gene Classifiers and Oncotype DX (Nanostring)
Head-to-Head Comparison of 18-Gene-Based Clinical-Genomic Model and Oncotype DX 21-Gene Assay for Predicting Recurrence of Early-stage Breast Cancer
NCT03772197CI-TRIAL-00036183completedClinicalTrials.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)
A recurrence index for distant recurrence (RI-DR), an 18-gene-based clinical-genomic model, has been developed for early-stage breast cancer (EBC). In this study, Investigators compared the prognostic performance of the RI-DR with the Oncotype DX (ODx) recurrence score (RS) for any recurrence risk type.
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Recurrence | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- The locoregional recurrence (LRR) rate, within 5 years after surgery.
- timeFrame
- 5 years
- description
- LRR risk calculated by 18-GC of breast cancer patients would be classified into high risk
- measure
- The distant recurrence(DR) rate, within 5 years after surgery.
- timeFrame
- 5 years
- description
- DR risk calculated by 18-GC of breast cancer patients would be classified into high risk
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients who have performed (Oncotype Dx) genetic testing methods before June 30, 2017. 2. Surgery (mastectomy or breast preservation) as the first treatment. 3. ER or PR IHC positive 4. HER2 negative 5. N0-N1 patient 6. Available with FFPE tumor tissue Exclusion Criteria: 1. T3-T4 or N2-N3 2. With distant metastasis before surgery 3. Preoperative chemotherapy / radiotherapy 4. Insufficient FFPE tumor samples
References
Publications (0)
Data not yet available
No reference posted for this study.