Clinical trial · Observational
Impact of Oncotype DX® on Treatment Recommendation and Its Economic Evaluation Under the Brazilian Society Perspective
Impact of Oncotype DX® on Treatment Recommendation of for Early-stage Hormone Receptor-positive Breast Cancer and Its Economic Evaluation Under the Brazilian Society Perspective
- 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)
155 Pérola Byington Hospital patients presenting early stage luminal BC were submitted to Oncotype Dx® evaluation. Changes in treatment recommendations and costs were obtained from Pérola Byington Hospital. Oncotype DX® incorporation in the Brazilian Public Health System should be considered, as it results in high clinical impact for patient and high economic impact for health system, being a tool that safely and accurately delimits the subgroup of patients who really need AC.
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 |
|---|---|---|---|
| Adjuvant Treatment | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cost | Other | — | UNRESOLVED |
| Oncotype DX® Assay | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Single arm
- description
- All patients will have the test
- interventionNames
- Genetic: Oncotype DX® Assay
- Other: Cost
Primary outcomes (2)
- measure
- The proportion of patients whose choice of treatment is changed as a result of Oncotype Test Low risk
- timeFrame
- up to 3 weeks
- description
- Changes based on initial clinical measures
- measure
- Economic evaluation
- timeFrame
- up to 5 years
- description
- The costs of each scenario
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Women ≥ 18 years Early stage breast cancer, ER and/or PR positive with HER2 negative breast cancer. Exclusion Criteria: More than one operable primary breast tumor; Multifocal or multicentric tumors; 4 or more lymph node involvement; Metastatic breast cancer; Previous history of breast cancer; Invasive tumor \<2 mm ; Performance status \> 2 and / or other clinical factors that would make the patient a non-viable candidate for adjuvant chemotherapy; Previous hormonal or chemotherapy treatment; Current medical condition that would interfere with their ability to consent (psychiatric illness, for example)
References
Publications (0)
Data not yet available