Status:
COMPLETED
Parallel Comparison of 18 Gene Classifiers and Oncotype DX (Nanostring)
Lead Sponsor:
Amwise Diagnostics Pte. Ltd.
Conditions:
Breast Cancer
Recurrence
Eligibility:
FEMALE
18-75 years
Brief Summary
A recurrence index for distant recurrence (RI-DR), an 18-gene-based clinical-genomic model, has been developed for early-stage breast cancer (EBC). In this study, Investigators compared the prognostic...
Detailed Description
With improved diagnosis, breast cancer can now be detected at early stages, thus improving survival rates. However, overtreatment is common; considering that the risk of recurrence is low, patients ma...
Eligibility Criteria
Inclusion
- Patients who have performed (Oncotype Dx) genetic testing methods before June 30, 2017.
- Surgery (mastectomy or breast preservation) as the first treatment.
- ER or PR IHC positive
- HER2 negative
- N0-N1 patient
- Available with FFPE tumor tissue
Exclusion
- T3-T4 or N2-N3
- With distant metastasis before surgery
- Preoperative chemotherapy / radiotherapy
- Insufficient FFPE tumor samples
Key Trial Info
Start Date :
June 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2018
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT03772197
Start Date
June 1 2018
End Date
November 1 2018
Last Update
December 19 2018
Active Locations (1)
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1
Amwise
Taipei, Taiwan, 106