Parallel Comparison of 18 Gene Classifiers and Oncotype DX (Nanostring)

Study Overview
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Brief Summary
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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 performance of the RI-DR with the Oncotype DX (ODx) recurrence score (RS) for any recurrence risk type.

Detailed Description
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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 may suffer from side effects without receiving the full benefits of adjuvant therapies. To overcome the imprecision of prognosis based on clinicopathologic factors, genomic tests for breast cancer prognosis, such as the Oncotype DX® (ODx), MammaPrint®, and EndoPredict® assay kits, are frequently utilized. These multigene panels were development based on Caucasian populations, and may not suitable to Asian population due to the differences in the incidence and lifestyle of breast cancer patients from different ethic backgrounds. To fiil this gap, an 18-gene classifier (18-GC) based on the gene-expression profiling of Chinese breast cancer patients was developed In the current study, investigators combined clinical variables and genetic information to generate a clinical-genomic model: RI-DR, a recurrence index for distant recurrence (based on a genomic model and 6 clinical variables: age, tumor size, lymph node status, estrogen receptor status, lymphovascular invasion, tumor grading). By using tissues that have been tested with ODx, in this study, investigators evaluated the performance of the RI-DR model with that of the ODx assay in the prognosis assessment of a cohort of patients from Taiwan.

Official Title
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Head-to-Head Comparison of 18-Gene-Based Clinical-Genomic Model and Oncotype DX 21-Gene Assay for Predicting Recurrence of Early-stage Breast Cancer

Conditions
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Breast Cancer, Recurrence

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: T3-T4 or N2-N3 With distant metastasis before surgery Preoperative chemotherapy / radiotherapy Insufficient FFPE tumor samples

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The locoregional recurrence (LRR) rate, within 5 years after surgery. | LRR risk calculated by 18-GC of breast cancer patients would be classified into high risk | 5 years | 
| The distant recurrence(DR) rate, within 5 years after surgery. | DR risk calculated by 18-GC of breast cancer patients would be classified into high risk | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Distant recurrence, NanoString, Gene-expression profiling, Prognosis, Locoreginal recurrence