Clinical trial · Observational
Probability of OncotypeDx to Reallocate As Low or High Risk of Recurrence Breast Cancer Patients with Uncertain Biology
Prospective Study Evaluating the Probability of OncotypeDx to Allocate At Low or High Risk of Recurrence Early ER Positive HER2 Negative Breast Cancer Patients with Uncertain Biological Behavior Evaluated by Pathological Parameters
NCT06363812CI-TRIAL-00086599completedClinicalTrials.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)
In some cases of hormone receptor positive, human epidermal growth factor receptor 2 (HER2) negative early breast cancer the benefit of adding adjuvant chemotherapy to hormonal treatment, estimated on the basis of the classical clinico-pathological parameters, is unclear. In these cases the application of a genomic test could be useful in guiding the therapeutic choice.
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 (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- the proportion of tumor samples with a useful OncotypeDx
- timeFrame
- 15 days
- description
- number of low risk and high risk at OncotypeDx divided by the total number of tests
Secondary outcomes (2)
- measure
- the proportion of patients in which the result of the test has induced a modification in the initial treatment plan
- timeFrame
- 15 days
- description
- number of cases with a therapeutic change divided by the total number of tested cases
- measure
- the proportion of tumor samples with an intermediate risk or not evaluable at OncotypeDx
- timeFrame
- 15 days
- description
- number of intermediate risk and not evaluable at OncotypeDx divided by the total number of tests
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological diagnosis of infiltrating ductal or lobular ER+ HER2- early breast cancer adequately treated with surgery * Nodal status: no regional lymph node metastasis (pN0) or micrometastatic regional lymph node (pN1mic) * Uncertain biological behavior defined by all of the following parameters: ER \>20% and progesterone receptor (PgR) \>20% and Ki67 between 14% and 30% and G2 * Written informed consent Exclusion Criteria: * pathologic tumor stage (pT) \> 5 cm (not applicable to the internal control group) * Prior neoadjuvant therapy * Evidence of metastatic disease * No axillary exploration (sentinel lymph node biopsy or axillary dissection) * Multifocal or multicentral or bilateral tumors
References
Publications (7)
- BACKGROUNDAlbain KS, Barlow WE, Shak S, Hortobagyi GN, Livingston RB, Yeh IT, Ravdin P, Bugarini R, Baehner FL, Davidson NE, Sledge GW, Winer EP, Hudis C, Ingle JN, Perez EA, Pritchard KI, Shepherd L, Gralow JR, Yoshizawa C, Allred DC, Osborne CK, Hayes DF; Breast Cancer Intergroup of North America. Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial. Lancet Oncol. 2010 Jan;11(1):55-65. doi: 10.1016/S1470-2045(09)70314-6. Epub 2009 Dec 10. PMID 20005174
- BACKGROUNDCheang MC, Chia SK, Voduc D, Gao D, Leung S, Snider J, Watson M, Davies S, Bernard PS, Parker JS, Perou CM, Ellis MJ, Nielsen TO. Ki67 index, HER2 status, and prognosis of patients with luminal B breast cancer. J Natl Cancer Inst. 2009 May 20;101(10):736-50. doi: 10.1093/jnci/djp082. Epub 2009 May 12. PMID 19436038
- BACKGROUNDDowsett M, Cuzick J, Wale C, Forbes J, Mallon EA, Salter J, Quinn E, Dunbier A, Baum M, Buzdar A, Howell A, Bugarini R, Baehner FL, Shak S. Prediction of risk of distant recurrence using the 21-gene recurrence score in node-negative and node-positive postmenopausal patients with breast cancer treated with anastrozole or tamoxifen: a TransATAC study. J Clin Oncol. 2010 Apr 10;28(11):1829-34. doi: 10.1200/JCO.2009.24.4798. Epub 2010 Mar 8. PMID 20212256
- BACKGROUNDEarly Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 May 14-20;365(9472):1687-717. doi: 10.1016/S0140-6736(05)66544-0. PMID 15894097
- BACKGROUNDHarris LN, Ismaila N, McShane LM, Hayes DF. Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline Summary. J Oncol Pract. 2016 Apr;12(4):384-9. doi: 10.1200/JOP.2016.010868. Epub 2016 Mar 8. No abstract available.