Status:
COMPLETED
The Impact of the Gene Recurrence Score on Chemotherapy Prescribing in ER Positive, Lymph Node Positive Early Stage Breast Cancer
Lead Sponsor:
Cancer Trials Ireland
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Brief 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 chemotherap...
Detailed Description
After a breast cancer and any lymph glands have been surgically removed, further (adjuvant) treatment is generally given to reduce the risk of cancer recurrence. For patients with estrogen receptor (E...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- General Inclusion Criteria (All Patients)
- 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))
- Inclusion Criteria - Cohort 1 (Postoperative Patients): N= 75
- 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))
- Involvement of 1-3 lymph nodes (N1, including micrometastases)
- Inclusion Criteria - Cohort 2 (Preoperative Patients): N= 75
- Candidates for preoperative therapy for early breast cancer
- T2-T4 tumours
- Involvement of at least one lymph node, (including micrometastases) on biopsy
- Adequate tissue from core biopsy for 21 gene RS testing (approximate minimum 5mm)
- Exclusion Criteria (All patients):
- 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-)
- Known metastatic breast cancer
- Performance status ≥ 2
- Patients not considered by their treating physician to be fit to undergo chemotherapy.
- Men with breast cancer.
Exclusion
Key Trial Info
Start Date :
March 16 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 2 2021
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT03843346
Start Date
March 16 2017
End Date
February 2 2021
Last Update
January 10 2025
Active Locations (10)
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1
Letterkenny University Hospital
Letterkenny, Co. Donegal, Ireland
2
St Vincent's University Hospital
Dublin, Dublin 4, Ireland
3
Mater Misericordiae University Hospital & Mater Private Hospital
Dublin, Dublin 7, Ireland
4
Beaumont Hospital
Dublin, Dublin 9, Ireland