Clinical trial · Interventional
A Prospective Cohort Study to Evaluate the Oncotype DX® Test in Early Stage Breast Cancer
NCT01423890CI-TRIAL-00014122ONCOTYPEDXcompletedN/AClinicalTrials.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 prospective population-based cohort study is being conducted in Ontario to evaluate whether the performance of Oncotype DX® changes the treatment recommended and the treatment received in women or men with node negative, ER positive breast cancer who are receiving (or will receive) endocrine therapy and who are candidates for chemotherapy. One thousand eligible consenting women and men will have their tumor tissue specimen sent to Genomic Health where the Oncotype DX® assay will be performed.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ONCOTYPEDX Test | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Early Stage Breast Cancer
- description
- Women and men with node negative, ER positive breast cancer who are receiving (or will receive) endocrine therapy, and who are candidates for chemotherapy.
- interventionNames
- Genetic: ONCOTYPEDX Test
Primary outcomes (1)
- measure
- Change in treatment recommendation
- timeFrame
- One month
- description
- The primary outcome is the change in treatment recommendation by the oncologist and the change in treatment preference of the patient.
Secondary outcomes (3)
- measure
- Association between Oncotype DX® RS with other estimated risk calculations
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women or men with histologic evidence of invasive breast cancer (ductal, lobular or mixed disease). * Surgical resection including breast conserving surgery or modified radical mastectomy or simple mastectomy, within the last four months. * Axillary lymph nodes assessed for tumor by: (i) sentinel node biopsy, or (ii) axillary node dissection, or (iii) both * Axillary lymph node assessment negative for cancer, or positive only for micrometastases (i.e., cancer \<2mm by H\&E stain). * Tumor is estrogen receptor (ER) positive. * Receiving or to receive adjuvant endocrine therapy (i.e., tamoxifen or aromatase inhibitor). * Being considered for adjuvant chemotherapy. Exclusion Criteria: * Axillary lymph node positive for cancer. * Patients with inoperable locally advanced breast cancer. * Metastatic breast cancer, including local ipsilateral recurrence. * HER2 neu positive. * Physician/Patient unwilling to comply with study protocol. * Inability to provide informed consent (e.g. dementia or severe cognitive impairment).
References
Publications (0)
Data not yet available
No reference posted for this study.