The Impact of the Gene Recurrence Score on Chemotherapy Prescribing in ER Positive, Lymph Node Po… (NCT03843346) | Clinical Trial Compass
CompletedNot Applicable
The Impact of the Gene Recurrence Score on Chemotherapy Prescribing in ER Positive, Lymph Node Positive Early Stage Breast Cancer
Ireland87 participantsStarted 2017-03-16
Plain-language summary
This study examines the impact of an additional tumour test called the 21 gene Recurrence Score (OncotypeDx®), a commercially available test on a Medical Oncologist's decision to recommend chemotherapy.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Age 18 years of age or older
✓. ER Positive Tumours (≥1% positive cells or Allred score ≥ 2 (Appendix 1))
✓. Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer (0-1 by IHC or FISH \<2.0)
✓. No evidence of metastatic disease on CT, bone scan or other imaging
✓. Fit for consideration of chemotherapy as determined by the Investigator
✓. Adequate performance status (Eastern Cooperative Oncology Group (ECOG) 0 or 1 (Appendix 2))
✓. Adequate surgical excision of breast tumour (mastectomy or lumpectomy) and lymph nodes (sentinel lymph biopsy or axillary dissection)
✓. Any tumour size (T stage (Appendix 3))
Exclusion criteria
✕. ER negative tumour (Allred score 0-1)
✕. HER2 positive tumours as defined by IHC 3+ or FISH ≥ 2.0
✕. Node negative disease, including those with Isolated tumour cells only (node negative i+/i-)