Clinical trial · Observational
(Oncotype DX®) in Estrogen Receptor Positive (ER+) HER-2 Negative (HER 2-) 1-3 Node Positive (pN1) Breast Cancer
A Prospective Clinical Utility Study of the Impact of the 21 Gene Recurrence Score® Assay (Oncotype DX®) in Estrogen Receptor Positive (ER+) HER-2 Negative (HER 2-) 1-3 Node Positive (pN1) Breast Cancer in Multiple BC Cancer Agency Centres
- 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)
This study is a multi-center BCCA study that evaluates the impact of the Oncotype DX® assay on the decision making of the treating physician and the patient. The Oncotype DX® assay is a commercially available diagnostic test that aids in a physician's treatment recommendation to a breast cancer patient. The study also has a pharmacoeconomic component.
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 |
|---|---|---|---|
| Oncotype DX | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Oncotype DX® assay affect on physician's treatment recommendations assessed by questionnaire
- timeFrame
- 1 Month
- description
- The Oncotype DX® assay affect on physician's treatment recommendations pre and post Oncotype DX® Recurrence Score® result.
Secondary outcomes (1)
- measure
- Assessing Costs differences to the Publicly funded Health Care System
- timeFrame
- Data will be analyzed within 8 weeks of enrollment completion and presented within 9 months of study completion
- description
- Costs to a publicly funded health care system
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: 1. Operable breast cancer with the primary tumour (pT1-3) 2. Pathological involvement (microscopic) of 1-3 lymph nodes. No minimum number of total lymph nodes need be resected. Extra-nodal extension of nodal deposit is allowed. 3. Her2Neu negative by IHC (0 or 1+) or FISH by current ASCO/CAP guidelines 4. Patient's tumor must undergo central review at GHI and there must be adequate material for the Oncotype DX® assay. 5. Patient's tumor must contain estrogen receptors (ER+). 6. Patient must be between the ages (inclusive) of 18-79. 7. Patient must be able to give informed consent 8. Patient has adequate performance status (PS ECOG 0,1 or Karnofsky ≥70) and be a medically fit candidate for treatment of their cancer with systemic chemotherapy in addition to hormonal therapy with no contra-indications to either systemic therapy maneuvers Exclusion Criteria: 1. Patients have ER negative tumors (ER-) by local or central BCCA assessment 2. Patients have HER2 positive tumors by local or central BCCA assessment 3. Patients have four or more lymph node positive disease. 4. Lymph node involvement by isolated tumor cells or cells by IHC only (less than 200 cells and/or ≤0.2 mm) 5. Patients have known metastatic breast cancer. 6. Patients are unable to give consent or understand written language. 7. Patients with poor performance status (ECOG 2-4) in whom consideration of adjuvant chemotherapy or adjuvant hormonal therapy would be contraindicated. 8. Pregnant women in whom consideration of adjuvant chemotherapy or adjuvant hormonal therapy would be contraindicated. 9. Patients with tumors that on GHI central pathological review appears inadequate for the Oncotype DX® assay.
References
Publications (1)
- RESULTDavidson JA, Cromwell I, Ellard SL, Lohrisch C, Gelmon KA, Shenkier T, Villa D, Lim H, Sun S, Taylor S, Taylor M, Czerkawski B, Hayes M, Ionescu DN, Yoshizawa C, Chao C, Peacock S, Chia SK. A prospective clinical utility and pharmacoeconomic study of the impact of the 21-gene Recurrence Score(R) assay in oestrogen receptor positive node negative breast cancer. Eur J Cancer. 2013 Jul;49(11):2469-75. doi: 10.1016/j.ejca.2013.03.009. Epub 2013 Apr 20. PMID 23611660