Clinical trial · Observational
Oncotype DX in BRCA-mutated Breast Cancer Patients: Our Experience. A Retrospective Observational Monocentric Study
NCT06484725CI-TRIAL-00078523OnBRAcompletedClinicalTrials.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 aims to evaluate the distribution of the Oncotype DX RS® genomic test in patients with ER-positive and HER2-negative breast cancer treated from January 2012 to December 2021, focusing on patients presenting germline mutations.
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 |
| Genetic Predisposition | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oncotype DX assay | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Wild type patients
- description
- Patients with no mutations or VUS in Breast Cancer-related genes candidated to surgery as primary treatment and eligible for Oncotype DX assay.
- interventionNames
- Genetic: Oncotype DX assay
- label
- VUS patients
- description
- Patients with VUS in Breast Cancer-related genes candidated to surgery as primary treatment and eligible for Oncotype DX assay.
- interventionNames
- Genetic: Oncotype DX assay
- label
- Mutated patients
- description
- Patients with mutation in Breast Cancer-related genes candidated to surgery as primary treatment and eligible for Oncotype DX assay.
- interventionNames
- Genetic: Oncotype DX assay
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age at diagnosis at least 18 years * Women who underwent breast surgery in OSR * Patients with ER-positive, HER2-unamplified early-stage BC who underwent the Oncotype DX assay, according to the standard of care. Exclusion Criteria: * Male * ER negative or HER2 amplified disease * Patient s who did not undergo breast surgery in OSR * Patient s who did not undergo the Oncotype Dx assay
References
Publications (0)
Data not yet available
No reference posted for this study.