Clinical trial · Interventional
The Impact of the Oncotype DX® Breast Cancer Assay on Treatment Decisions in a Canadian Population
The Impact of the Oncotype DX® Breast Cancer Assay on Treatment Decisions in a Canadian Population of Patients With Estrogen Receptor- Positive Early Breast Cancer With 1-3 Positive Lymph Nodes
- 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 main goal of this study is to characterize whether the results of the Oncotype DX® assay affect the physician's treatment recommendations for the adjuvant treatment of women with ER-positive (ER+), early breast cancer (EBC) with 1-3 positive lymph nodes who are potential candidates for chemotherapy, but for whom the benefits of chemotherapy may be uncertain.
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 |
|---|---|---|---|
| Hormone Receptor Positive Malignant Neoplasm of Breast | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Questionnaires, Oncotype Dx Assay | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Early stage breast cancer
- description
- Women with node positive (1-3 nodes), ER positive breast cancer who are receiving (or will receive) endocrine therapy, and who are candidates for chemotherapy. Study subjects will have ONCOTYPE Dx assay performed on their breast tumors, and will complete study questionnaires.
- interventionNames
- Other: Questionnaires, Oncotype Dx Assay
Primary outcomes (1)
- measure
- Change in physicians' treatment recommendations
- timeFrame
- 2-4 weeks
Secondary outcomes (3)
- measure
- Change in patient's treatment preference and level of confidence in treatment plan
- timeFrame
- 2-4 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have undergone surgical treatment for breast cancer with adequate evaluation of lymph node status with a sentinel lymph node procedure or full axillary dissection, with positive involvement of 1-3 axillary lymph nodes as confirmed by histologic examination. * ECOG performance status 0 or 1 * Patient must be a candidate for treatment of their cancer with systemic chemotherapy in addition to hormonal therapy * Eligible Staging Criteria: T1-3 N1 M0 * Breast tumor must undergo central pathology review at GHI and must be found adequate for the Oncotype DX assay. * Breast tumor must be estrogen-receptor positive and HER2 positive (IHC/FISH) as per institutional guidelines Exclusion Criteria: * Patient has a prior history of breast cancer in the same breast * Patient as been newly diagnosed with more than one operable primary breast tumor * Patient has multi-centric tumors (note: patients with multi-focal tumors may be included) * Patient has known metastatic breast cancer * Patient has \<2mm invasive tumor as assessed by local pathologist * Patient has received any kind of neoadjuvant treatment * Presence of clinical factors rendering the patient a non-viable candidate for adjuvant chemotherapy * Presence of a current medical condition that would interfere with patient's ability to consent and participate in this study
References
Publications (0)
Data not yet available