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临床试验/NCT03772197
NCT03772197已完成不适用

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

Amwise Diagnostics Pte. Ltd.1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2018年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
138
试验地点
1
主要终点
The locoregional recurrence (LRR) rate, within 5 years after surgery.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients who have performed (Oncotype Dx) genetic testing methods before June 30,
  • Surgery (mastectomy or breast preservation) as the first treatment.
  • ER or PR IHC positive
  • HER2 negative
  • N0-N1 patient
  • Available with FFPE tumor tissue

排除标准

  • T3-T4 or N2-N3
  • With distant metastasis before surgery
  • Preoperative chemotherapy / radiotherapy
  • Insufficient FFPE tumor samples

结局指标

主要结局

The locoregional recurrence (LRR) rate, within 5 years after surgery.

时间窗: 5 years

LRR risk calculated by 18-GC of breast cancer patients would be classified into high risk

The distant recurrence(DR) rate, within 5 years after surgery.

时间窗: 5 years

DR risk calculated by 18-GC of breast cancer patients would be classified into high risk

次要结局

未报告次要终点

研究者

发起方
Amwise Diagnostics Pte. Ltd.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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